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Introduction: There are no randomized trials studying the outcomes of mechanical aspiration thrombectomy (MAT) for management of pulmonary embolism (PE). Methods: We performed a systematic review and meta-analysis of existing literature to evaluate the safety and efficacy of MAT in the setting of PE. Inclusion criteria were as follows: studies reporting more than five patients, study involved MAT, and reported clinical outcomes and pulmonary artery pressures. Studies were excluded if they failed to separate thrombectomy data from catheter-directed thrombolysis data. Databases searched include PubMed, EMBASE, Web of Science until April, 2021. Results: Fourteen case series were identified, consisting of 516 total patients (mean age 58.4 ± 13.6 years). Three studies had only high-risk PE, two studies had only intermediate-risk PE, and the remaining nine studies had a combination of both high-risk and intermediate-risk PE. Six studies used the Inari FlowTriever device, five studies used the Indigo Aspiration system, and the remaining three studies used the Rotarex or Aspirex suction thrombectomy system. Four total studies employed thrombolytics in a patient-specific manner, with seven receiving local lysis and 17 receiving systemic lysis, and 40 receiving both. A random-effects meta-analyses of proportions of in-hospital mortality, major bleeding, technical success, and clinical success were calculated, which yielded estimate pooled percentages [95% CI] of 3.6% [0.7%, 7.9%], 0.5% [0.0%, 1.8%], 97.1% [94.8%, 98.4%], and 90.7% [85.5%, 94.3%]. Conclusion: There is significant heterogeneity in clinical, physiologic, and angiographic data in the currently available data on MAT. RCTs with consistent parameters and outcomes measures are still needed.

Purpose To evaluate the ability of preprocedural computed tomography angiography (CTA) to predict the technical success of embolization of type II endoleak arising from a lumbar artery after endovascular aortic repair (EVAR). Materials and Methods All patients at a single academic institution who underwent angiography with possible embolization for a post-EVAR lumbar-supplied type II endoleak from 2009 to 2018 were retrospectively reviewed. Patients who did not undergo CTA before the procedure were excluded. CTAs were reviewed for the ability to trace the entire course of a feeding vessel from the internal iliac artery (IIA) to the lumbar artery at the site of the endoleak. Procedural imaging was reviewed for technical success, defined as the catheterization and embolization of the aneurysm sac through a lumbar artery. Results Fifty-seven angiograms with a type II endoleak and suspected feeding lumbar artery were identified. On CTA acquired before the procedure, the arterial path supplying this lumbar artery could be traced from the IIA to the aneurysm sac in 18 (32%) patients. Embolization was technically successful in 16 of these 18 (89%) procedures compared with 10 of 39 (26%) procedures in which the supplying artery could not be traced using CTA (P Conclusions A potential catheter path from the IIA through the iliolumbar and lumbar arteries to the aneurysm sac can be traced on preprocedural CTA in the minority of lumbar-supplied type II endoleaks. The ability to trace these inflow vessels may predict technical success during embolization. The low rate of technical success when the feeding vessel could not be traced using CTA suggests that these patients should be considered for percutaneous or transcaval sac puncture.

Purpose To formulate a statistical model relating ablation time, power, and work with posttreatment cavity volume following percutaneous microwave ablation of hepatic tumors in vivo. Materials and Methods A retrospective review (October 2015 to October 2018) yielded 122 hepatic tumors treated with microwave ablation. Ablation cavity dimensions were measured at 1-month follow-up examination and calculated using an ellipsoid volume formula. The antenna manufacturer (Neuwave Medical, Madison, Wisconsin) provided the activation time and energy used to calculate the antenna work. Generalized estimating equations with ordinary least-squares regression models were obtained to relate tumor volume with cumulative antenna work. Coefficient of determination (R2) and mean square error were used as statistical measures of model prediction performance. Results There is a logarithmic relationship between postablation cavity volume (cm3) and cumulative work (kJ), represented by the formula: log10 cm3 = −0.4583 + 0.9887 × cumulative work (log10 kJ) (R2 = 0.41, mean square error, 0.102). Ablation volumes were predicted as a function of antenna work, calculated using an antilog transformation. When a single antenna was used, ablation cavity volume was predicted using a generalized estimating equation ordinary least-squares regression model of power and time: log10cm3= −0.0546 + 0.0485 × total time (min) + 0.0107 × power (W) (R2 = 0.30; mean square error, 0.106). Using this model, a nomogram was developed to predict the postablation cavity volume based on total activation time and target power. Conclusion There is a logarithmic relationship between the ablation work and posttreatment ablation cavity volume, which can be expressed in a nomogram when using a single probe.

Catheter-directed thrombolysis (CDT) has been associated with rapid recovery of right ventricular (RV) function. The Bashir catheter was developed for enhanced thrombolysis in large vessels such as the pulmonary arteries (PAs) with lower doses of tissue plasminogen activator (tPA).The aim of this study was to evaluate the efficacy and safety of tPA infused using a pharmacomechanical (PM) CDT device called the Bashir endovascular catheter in patients with intermediate-risk acute pulmonary embolism (PE).Patients with symptoms of acute PE with computed tomographic evidence of RV dilatation were enrolled. The Bashir catheter was used to deliver 7 mg tPA into each PA over 5 hours. The primary efficacy endpoint was the core laboratory-assessed change in computed tomographic angiography-derived RV/left ventricular (LV) diameter ratio at 48 hours, and the primary safety endpoint was serious adverse events (SAEs) including major bleeding at 72 hours.At 18 U.S. sites, 109 patients were enrolled. The median device placement time was 15 minutes. At 48 hours after PM-CDT, the RV/LV diameter ratio decreased by 0.56 (33.3%; P 0.0001). PA obstruction as measured by the refined modified Miller index was reduced by 35.9% (P 0.0001). One patient (0.92%) had 2 SAEs: a retroperitoneal bleed (procedure related) and iliac vein thrombosis (device related). Two other procedure-related SAEs were epistaxis and non-access site hematoma with anemia.PM-CDT with the Bashir endovascular catheter is associated with a significant reduction in RV/LV diameter ratio and a very low rate of adverse events or major bleeding in patients with intermediate-risk acute PE. The notable finding was a significant reduction in PA obstruction with low-dose tPA. (Recombinant tPA by Endovascular Administration for the Treatment of Submassive PE Using CDT for the Reduction of Thrombus Burden [RESCUE]; NCT04248868).

Fibromuscular dysplasia is a nonatherosclerotic, under-recognized disorder primarily seen in middle-aged women. It can lead to several complications, such as hypertension, headaches, dissections, aneurysms, myocardial infarctions, and cerebrovascular accidents, to name a few. This article provides a comprehensive review of current literature on epidemiology, etiology, diagnosis, treatment, and long-term surveillance and fibromuscular dysplasia management. In addition, it renders the role of education and prevention for patients living with this condition and family screening. Lastly, it emphasizes the importance of a comprehensive multidisciplinary care model and patient input, given the complexity of this disease and its systemic presence and protean manifestations.

Outflow graft complications after left ventricular assist device placement are infrequent but highly morbid. In this case report, we describe endovascular repair of multiple outflow graft defects with external hemorrhage in a complex patient using overlapping stent grafts. This approach successfully stopped the outflow graft hemorrhage and temporized the patient for subsequent cardiac transplantation.

Purpose To evaluate psoas muscle area (PMA) as a predictor of all-cause mortality after endovascular aneurysm repair (EVAR) and compare it with other predictor variables. Material and Methods Retrospective review of 407 patients who underwent EVAR over a 7-year period was performed. Demographics, comorbidity variables, and outcomes were collected. Preprocedure computed tomography scans were used to measure the PMA. Descriptive statistics summarized the demographic information and predictor variables. Kaplan-Meier analysis and univariate and multivariate Cox proportional regression analyses were performed. The main outcome measure was survival time. Results Median survival time for patients with PMA in the lowest quartile of the distribution (≤1442 mm2) was 65.5 months (95% confidence interval [95% CI] 37.7–78.9) vs 91.2 months (95% CI 77.9–110.0 when PMA >1442 mm2). Multivariate analysis revealed lower PMA was associated with decreased survival (adjusted hazard ratio [AHR] 1.68; 95% CI 1.15–2.40, P = .006). Similarly, the presence of coronary artery disease (AHR 1.54, 95% CI 1.01–2.35, P = .045) and statin use after EVAR were associated with decreased survival (AHR 2.36, 95% CI 1.24–4.49, P = .009). Hyperlipidemia was associated with increased survival after EVAR (AHR 0.51, 95% CI 0.33–0.81, P = .004). Compared with patients with low body mass index (BMI) ( Conclusions Although PMA is a risk factor for decreased survival time, other factors such as patient hyperlipidemia, presence of coronary artery disease, post-EVAR statin use, and BMI are also predictive of postoperative mortality.

Few studies have documented relationships between endovascular therapy, duplex ultrasonography (DUS), post-thrombotic syndrome (PTS), and quality of life (QOL). The Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT) trial randomized 692 patients with acute proximal deep vein thrombosis (DVT) to receive anticoagulation or anticoagulation plus pharmacomechanical catheter-directed thrombolysis (PCDT). Compression DUS was obtained at baseline, 1 month and 12 months. Reflux DUS was obtained at 12 months in a subset of 126 patients. Clinical outcomes were collected over 24 months. At 1 month, patients who received PCDT had less residual thrombus compared to Control patients, evidenced by non-compressible common femoral vein (CFV) (21% vs 35%, p < 0.0001), femoral vein (51% vs 70%, p < 0.0001), and popliteal vein (61% vs 74%, p < 0.0001). At 12 months, in the ultrasound substudy, valvular reflux prevalence was similar between groups (85% vs 91%, p = 0.35). CFV non-compressibility at 1 month was associated with higher rates of any PTS (61% vs 46%, p < 0.001), a higher incidence of moderate-or-severe PTS (30% vs 19%, p = 0.003), and worse QOL (difference 8.2 VEINES-QOL (VEnous INsufficiency Epidemiological and Economic Study on Quality of Life) points; p = 0.004) at 24 months. Valvular reflux at 12 months was associated with moderate-or-severe PTS at 24 months (30% vs 0%, p = 0.01). In summary, PCDT results in less residual thrombus but does not reduce venous valvular reflux. CFV non-compressibility at 1 month is associated with more PTS, more severe PTS, and worse QOL at 24 months. Valvular reflux may predispose to moderate-or-severe PTS. ClinicalTrials.gov Identifier NCT00790335.

Purpose To characterize the degree of venous collateralization before and after endovascular therapy and determine the effect of collateralization on success of thrombolysis and rate of repeat intervention in patients with Paget–Schroetter syndrome. Materials and Methods A single-center retrospective study of 37 extremities in 36 patients (mean age, 32.64 y; range, 15–72 y; 24 men) with PSS treated with endovascular therapy from 2007 through 2017 was conducted. Venograms at presentation, after lysis, postoperatively, and at each repeat intervention were graded for venous stenosis, thrombus burden, and collateralization on a 5-point scale. Collateralization was classified as high-grade (9 extremities) or low-grade (28 extremities) based on grading of the venograms at presentation. Results Primary technical success rate for endovascular treatment was 100%. Eighty-six percent of patients (32 of 37) underwent thrombolysis, 91% (34 of 37) underwent mechanical thrombectomy, and 83% (30 of 37) underwent balloon angioplasty. Overall primary patency rate was 50% at 12 months. The repeat intervention rate within 12 months was significantly higher for extremities with high- vs low-grade collateralization (89% vs 43%; P = .016). There was a significant decrease in the median grade of collateral severity after initial intervention (2 vs 1; P = .044) and 1 day postoperatively (2 vs 1; P = .040) vs the venogram at presentation. Conclusions Severity of venous collateralization on the venogram at presentation of patients with PSS does not appear to affect success of endovascular therapy but may predict long-term patency of affected extremities. Patients in this cohort with severe collateralization on presentation were more likely to need repeat intervention.

This study evaluated the long-term outcomes of the Misago peripheral stent trial (Terumo) for atherosclerotic lesions in the superficial femoral artery (SFA) in patients with claudication.This was a prospective multicenter, single-arm, clinical trial of primary stent placement for de novo cases of SFA disease conducted in the United States and Asia. The primary endpoint was freedom from clinically driven target lesion revascularization (CD-TLR) at 36 months. Secondary outcomes were ankle-brachial index (ABI), Rutherford score, Walking Impairment Questionnaire (WIQ), a quality of life survey, and rate of device fracture.A total of 276 patients (64.4% male; mean age, 69.3 ± 10.1 years) were enrolled. Freedom from CD-TLR was 78.5% (95% confidence interval [CI], 73.0%-83.0%) at 24 months and 75.4% (95% CI, 69.6%-80.2%) at 36 months. Baseline ABI was 0.7 ± 0.1 and 0.98 ± 0.20 (P.001) at 30 days after the procedure. Baseline Rutherford score was 3.6 ± 0.6 and 1.6 ± 1.0 30 at 30 days after the procedure (P.001). Mean (and changed) ABI and Rutherford score at 36 months compared to day 30 after the procedure were, respectively, 0.91 (-0.1 ± 0.2) and 1.5 (-0.2 ± 1.1). WIQ score at baseline was 21.49 ± 26.30 and 50.51 ± 38.49 at 30 days after the procedure ( P.001). The mean WIQ score at 2 years was 46.65 ± 37.31 (P = .12). Stent fracture rate at 36 months was 2.0% (4 of 202 patients).OSPREY (Occlusive-Stenotic Peripheral Artery Revascularization Study) 36-month data demonstrated persistent freedom from CD-TLR and sustained improvement in ABI and Rutherford score with primary stent placement for SFA lesions.

Background Abdominal exploration followed by vascular bypass has been the standard of care for acute mesenteric ischemia (AMI), but there is increasing use of endovascular treatment with selective exploratory laparotomy. Methods We performed a retrospective review of patients diagnosed with AMI who underwent mesenteric artery angioplasty or stenting at a single institution from 2010-2017. Patients were divided into 3 groups: those who did not undergo exploratory laparotomy; those who received endovascular treatment before laparotomy (post-reperfusion laparotomy group); and those who had endovascular treatment after laparotomy (pre-reperfusion laparotomy group). Results Patients who did not undergo exploratory laparotomy showed 85.7% (12/14) survival, compared with 63.6% (7/11) in the post-reperfusion group and 25.0% (2/8) in the pre-reperfusion group, P=0.077). Time to reperfusion was significant (P=0.009) in predicting survival for patients who underwent exploratory laparotomy. Conclusion Emergent endovascular treatment prior to laparotomy seems to be associated with a higher survival.

The goal of thoracic endograft placement in type B aortic dissection is to prevent aneurysmal degeneration and other complications. Although TEVAR is a highly effective tool for managing type B aortic dissection, many patients will require additional interventions. In this article, we present a case-based review of techniques for the management of persistent false lumen perfusion and stent-graft induced new entry tears after TEVAR for aortic dissection.

Management of acute complicated Type B aortic dissection (TBAD) requires a multidisciplinary approach with careful evaluation and understanding of the complicating features. Patients who present with or progress to a complicated TBAD must be triaged and managed rapidly due to the high morbidity and mortality even in the presence of optimal medical, endovascular, and open therapies. When required, invasive therapies can be broken down most simply into four treatments: thoracic endograft placement, aortic fenestration, branch vessel stenting, and open repair. However, which therapy to offer and in which order is often unclear. In this review, focus is placed on clinical presentation, diagnosis, and explanation for one or a combination of these therapies. In addition, contraindications as well as expected outcomes, complications, and adjunct therapies will be reviewed. The advent of advanced endovascular techniques has certainly improved the immediate morbidity and mortality of acute complicated TBAD; however, much remains to learn about patient selection and therapeutic intervention performed.

Objectives: Endovascular treatment of atheromatous chronic total occlusions (CTOs) of the lower extremity using the subintimal arterial flossing with antegrade-retrograde intervention (SAFARI) method may fail due to inability to position the antegrade and retrograde wires in the same plane. Failed attempted SAFARI in three limbs, in two patients, was rescued using a gunsight technique. Material and Methods: Retrospective procedure database review revealed three procedures where an occlusion could not be crossed despite antegrade and retrograde access which were treated using a novel technique for percutaneous puncture through antegrade and retrograde loop snares (gunsight technique). Results: Three limbs in two patients (mean age: 64 years) were treated using the gunsight technique. All three CTOs were successfully crossed and dilated with angioplasty and/or stents. A positive clinical outcome was achieved in each of the three affected limbs. Conclusion: The gunsight technique can improve technical success of SAFARI in the treatment of CTOs for atheroocclusive disease when there is failure to cross the lesion with standard endoluminal or subintimal approaches.

Purpose: To evaluate short- and long-term technical and clinical outcomes after kissing stent treatment of aortoiliac occlusive disease (AIOD) based on an individual participant data (IPD) meta-analysis. Materials and Methods: A search of the Scopus database identified 156 articles on KS treatment of AIOD; of these 22 met the inclusion criteria. Authors of 19 articles with contact information were approached to join an IPD consortium. Eight author groups responded and 5 provided anonymized data for merging into an IPD database. The number of included procedures was equal before and after 2005. The primary study outcome was the cumulative patency at 24 months. Secondary outcomes were patency at up to 60 months, complications, and changes in Rutherford category and ankle-brachial index. The predictive value of stent protrusion length, pre-/postdilation, stent type, and patient demographics on primary patency were examined with Cox proportional hazard modeling; outcomes are reported as the hazard ratio (HR). The Kaplan-Meier method was employed to estimate patency rates. Results: In total, 605 (40.9%) of 1480 patients presented in the literature were included in the IPD analysis. The indication for intervention was intermittent claudication in 84.2% and critical limb ischemia in 15.8%. Lesions were classified as TransAtlantic Inter-Society Consensus (TASC) A or B in 52.8% and TASC C and D in 47.2%. The overall primary patency estimate was 81% at 24 months. Primary patency significantly increased after 2005 (p=0.005). Cox regression analysis revealed only age as a significant predictor of sustained primary patency (HR 0.60, p

PURPOSE To evaluate safety and retrieval success of retrievable suprarenal inferior vena cava (IVC) filters. MATERIALS AND METHODS A retrospective chart review of patients who received a retrievable suprarenal IVC filter between January 2008 and December 2017 was conducted. Suprarenal IVC filters were placed in 24 female and 27 male patients. The most common indications for filter placement were IVC thrombus (n = 20; 39.2%) and iliofemoral venous thrombosis with contraindication to anticoagulation (n = 16; 31.3%). The most common indications for suprarenal placement were IVC thrombus (n = 20; 39.2%), anatomic variants (n = 17; 33.3%), and external IVC compression (n = 8; 15.8%). Duplicated IVC was the most common anatomic variant requiring suprarenal placement (n = 7; 13.7%). RESULTS Gunther Tulip (n = 40; 78.4%), Denali (n = 10; 19.6%), and Celect (n = 1; 2.0%) filters were used. Retrieval was attempted in 27 of the 51 filters placed (52.9%). Of the 27 attempted retrievals, the technical success rate was 100% (27/27). The median dwell time was 87.0 days (95% confidence interval, 28-137 d). One complication involving fractured struts during filter retrieval occurred. No significant change in craniocaudal filter position, lateral filter tilt, or renal function between placement and retrieval was observed (P < .05). There were no instances of indwelling filter fracture. CONCLUSIONS Suprarenal IVC filters, when indicated, can be placed and retrieved with a low complication rate.

Many disorders of the kidney and adrenal gland are amenable to minimally invasive procedures. Although the range of procedures is large, there are several key procedures (such as percutaneous nephrostomy for nephrolithiasis or tumor, renal artery embolization for trauma or vascular masses, adrenal venous sampling for hyperaldosteronism, and renal angioplasty in the setting of fibromuscular dysplasia) that are commonly performed and should be familiar to every interventional radiologist. The goal of this chapter is to review the pathology of the kidney and adrenal gland, list the indications and contraindications for these standard procedures, and highlight the fundamental techniques for performing them.

Heat injuries of adjacent organs need to be considered when radiofrequency and microwave ablation procedures of hepatocellular carcinoma or hepatic metastases are performed, especially when the target lesion is in a subcapsular portion of the liver. Hydrodissection can be performed prior to radiofrequency or microwave ablation procedures in which the target lesion is in a subcapsular portion of the liver and adjacent to another structure, particularly the diaphragm. This technique creates a fluid layer thick enough to separate the nearby structures from the target lesion in the liver, providing thermal insulation around the ablation area. Moreover, if fluid (rather than CO2) is used, it improves the sonic window when the target lesion is not visible or only partially visible due to overlapping bowel, lung, or ribs.

We aimed to investigate patients with lower gastrointestinal bleeding who presented to the emergency department requiring initial conventional angiography. We report risk-stratified and mesenteric conventional angiography outcomes.We retrospectively reviewed patients with lower gastrointestinal bleeding between 2001 and 2012. We included all consecutive patients with clinical lower gastrointestinal bleeding with a requirement of further angiography and possible embolization. Patients who had prior interventions or surgery were excluded.A total of 88 patients (35 women, 53 men) with a median age of 71 years (range, 23-99 years) were included in the analysis. Conventional angiography was positive and endovascular treatment was intended in 35 patients. Once the source of bleeding was found angiographically, endovascular treatment had a technical success rate of 90.3% and clinical success rate of 71.4%. Overall early rebleeding rate (30 days) was 14.8% and late rebleeding rate (30 days) was 13.6%.Identifying the source of lower gastrointestinal bleeding remains to be a clinical and angiographic challenge. Although we did not observe an association between mortality and clinical success, increased early rebleeding rates were associated with higher mortality rates.

Interventional radiology (IR) is appealing to many caregivers because of the technical challenge, creative problem-solving opportunities, and the immediate gratification associated with a wide array of minimally invasive procedures. In addition to possessing excellent technical skills, interventional radiologists must also be able to provide comprehensive periprocedural care.

Mesenteric vasculitis is a rare diagnosis, but it comprises a group of disorders that may have devastating manifestations. It is often difficult to diagnose using clinical symptoms and biomarkers. Vascular imaging often provides the best opportunity for the noninvasive diagnosis of vasculitis and obviates the need for performing a biopsy. The medical management of vasculitis involves controlling the inflammatory process with the use of steroids or other immunosuppressants, but medical therapy does not consistently provide regression of the vascular changes (ie, aneurysms or vascular occlusions) seen at the time of the initial diagnosis. Operative management remains the mainstay of therapy for focal occlusive or aneurysms, but the treatment options for multifocal disease remain challenging. Endovascular treatment is increasingly being used as a first line of treatment for symptomatic vasculitis. Interventionalists should be familiar with the indications and outcomes associated with the various therapeutic options for mesenteric vasculitis-associated occlusive disease and aneurysms.

Thoracic duct embolization is a percutaneous, image-guided intervention used in the management of chylothorax. Chylothorax, or chylous leak in the chest, is a rare condition that represents a spectrum of disorders that have in common leakage of intestinal lymph (chyle) into the thorax. Although conservative and surgical management are the standard of care, we present an overview of lymphangiography and percutaneous thoracic duct embolization.

Venous compression syndromes present a diagnostic and therapeutic challenge as the clinical presentation can be vague, diagnostic criteria are often not present, and high quality standardization of when and how to treat is not available in part due to the limited number of cases reported and also due to the limited literature available. Significant venous compression should be considered when clinical symptoms correlate to location of compression and there is evidence of hemodynamic changes including venous hypertension, collateral/variceal formation, and/or thrombus formation. In general, treatment of venous compression should address the etiology of the compression as opposed to just treating symptoms associated with it such as significant varices or anticoagulation for thrombus to avoid recurrence of symptoms.

Supplemental Digital Content is available in the text., Background: Drug-coated balloons (DCBs) are a predominant revascularization therapy for symptomatic femoropopliteal artery disease. Because of the differences in excipients, paclitaxel dose, and coating morphologies, varying clinical outcomes have been observed with different DCBs. We report the results of 2 studies investigating the pharmacokinetic and clinical outcomes of a new DCB to treat femoropopliteal disease. Methods: In the ILLUMENATE Pivotal Study (Prospective, Randomized, Single-Blind, U.S. Multi-Center Study to Evaluate Treatment of Obstructive Superficial Femoral Artery or Popliteal Lesions With A Novel Paclitaxel-Coated Percutaneous Angioplasty Balloon), 300 symptomatic patients (Rutherford class 2–4) were randomly assigned to DCB (n=200) or standard angioplasty (percutaneous transluminal angioplasty [PTA]) (n=100). The primary safety end point was freedom from device- and procedure-related death through 30 days, and freedom from target limb major amputation and clinically driven target lesion revascularization through 12 months. The primary effectiveness end point was primary patency through 12 months. In the ILLUMENATE PK study (Pharmacokinetic Study of the Stellarex Drug-Coated Angioplasty Balloon), paclitaxel plasma concentrations were measured after last DCB deployment and at prespecified times (at 1, 4, 24 hours and at 7 and 14 days postprocedure) until no longer detectable. Results: In the ILLUMENATE Pivotal Study, baseline characteristics were similar between groups: 50% had diabetes mellitus, 41% were women, mean lesion length was 8.3 cm, and 44% were severely calcified. The primary safety end point was met (92.1% for DCB versus 83.2% for PTA, P=0.025 for superiority) and the primary patency rate was significantly higher with DCB (76.3% for DCB versus 57.6% for PTA, P=0.003). Primary patency per Kaplan-Meier estimates at day 365 was 82.3% for DCB versus 70.9% for PTA (P=0.002). The rate of clinically driven target lesion revascularization was significantly lower in the DCB cohort (7.9% versus 16.8%, P=0.023). Improvements in ankle-brachial index, Rutherford class, and quality of life were comparable, but the PTA cohort required twice as many revascularizations. Pharmacokinetic outcomes showed that all patients had detectable paclitaxel levels after DCB deployment that declined within the first hour (54.4±116.9 ng/mL to 1.4±1.0 ng/mL). Conclusions: The data demonstrate superior safety and effectiveness of the Stellarex DCB in comparison with PTA, and plasma levels of paclitaxel fall to low levels within 1 hour. Clinical Trial Registration: URL: http://clinicaltrials.gov. Unique identifiers: NCT01858428 and NCT01912937.