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Abstract The Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) is a prospective, randomized, multicenter clinical trial of carotid endarterectomy (CEA) versus carotid artery stenting (CAS) as prevention for stroke in patients with symptomatic stenosis greater than or equal to 50%. CREST is sponsored by the US National Institute of Neurological Disorders and Stroke (NINDS) of the US National Institutes of Health (NIH), with additional support by a device manufacturer, and will provide data to the US Food and Drug Administration (FDA) for evaluation of a stent device. Because of budget constraints for CREST, Health Care Financing Administration (HCFA) reimbursement for hospital costs incurred by CREST patients will be essential. The involvement of academic scientists, industry, and three separate government agencies (NIH, FDA, HCFA) has presented many challenges in conducting the trial. A review of the pathways followed to meet these challenges may be helpful to others seeking to facilitate sharing of the costs and burdens of conducting innovative clinical research.

Objectives: The goal of this study was to define the frequency of stent gaps by 64-detector computed tomographic angiography (CTA) and their relation to in-stent restenosis (ISR), stent fracture (SF), and overlap failure (OF). Background: SF defined by catheter angiography or intravascular ultrasound has been implicated in ISR. Methods: A total of 292 consecutive patients, with 613 stents, who underwent CTA were evaluated for stent gaps associated with decreased Hounsfield units. Correlations with catheter coronary angiography (CCA) were available in 143 patients with 384 stents. Results: Stent gaps were noted in 16.9% by CTA and 1.0% by CCA. ISR by CCA was noted in 46.1% of the stent gaps (p < 0.001) as determined by CCA, and stent gaps by CTA accounted for 27.8% of the total ISR (p < 0.001). In univariate analysis, stent diameter > or =3 mm was the only CCA characteristic significantly associated with stent gaps (p = 0.002), but was not a significant predictor by multivariate analysis. Bifurcation stents, underlying calcification, stent type, location, post-dilation, and overlapping stents were not observed to be predisposing factors. Excessive tortuosity and lack of conformability were not associated with stent gaps; however, their frequency was insufficient to permit meaningful analysis. Conclusions: Stent gap by CTA: 1) is associated with 28% of ISR, and ISR is found in 46% of stent gaps; 2) is associated with > or =3-mm stents by univariate (p = 0.002) but not by multivariate analysis; 3) is infrequently noted on catheter angiography; and 4) most likely represents SF in the setting of a single stent, and may represent SF or OF in overlapping stents. [ABSTRACT FROM AUTHOR]

Objective: Despite the publication of various national/international guidelines, several questions concerning the management of patients with asymptomatic (AsxCS) and symptomatic (SxCS) carotid stenosis remain unanswered. The aim of this international, multi-specialty, expert-based Delphi Consensus document was to address these issues to help clinicians make decisions when guidelines are unclear., Methods: Fourteen controversial topics were identified. A three-round Delphi Consensus process was performed including 61 experts. The aim of Round 1 was to investigate the differing views and opinions regarding these unresolved topics. In Round 2, clarifications were asked from each participant. In Round 3, the questionnaire was resent to all participants for their final vote. Consensus was reached when ≥75% of experts agreed on a specific response., Results: Most experts agreed that: (1) the current periprocedural/in-hospital stroke/death thresholds for performing a carotid intervention should be lowered from 6% to 4% in patients with SxCS and from 3% to 2% in patients with AsxCS; (2) the time threshold for a patient being considered "recently symptomatic" should be reduced from the current definition of "6 months" to 3 months or less; (3) 80% to 99% AsxCS carries a higher risk of stroke compared with 60% to 79% AsxCS; (4) factors beyond the grade of stenosis and symptoms should be added to the indications for revascularization in AsxCS patients (eg, plaque features of vulnerability and silent infarctions on brain computed tomography scans); and (5) shunting should be used selectively, rather than always or never. Consensus could not be reached on the remaining topics due to conflicting, inadequate, or controversial evidence., Conclusions: The present international, multi-specialty expert-based Delphi Consensus document attempted to provide responses to several unanswered/unresolved issues. However, consensus could not be achieved on some topics, highlighting areas requiring future research., Competing Interests: Disclosures D.P.M. has given talks, acted as a consultant or attended conferences sponsored by Amgen and Novo Nordisk. J.F.M. receives funding from the United States National Institute of Neurologic Disorders and Stroke for work related to running the CREST-2 clinical trial (U01NS080168) and the CREST-2 Long-term Observational Extension study (U01NS119169). E.A.S. has received research grants from the United States Food and Drug Administration, BD, Boston Scientific, Cook, CSI, Laminate Medical, Medtronic and Philips; has received consulting/speaking fees from Abbott, Bayer, BD, Boston Scientific, Cook, Cordis, CSI, Inari, Infraredx, Medtronic, Philips, Shockwave and VentureMed. H.-H.E. is a local Principal Investigator for the ROADSTER 2 trial and a scientific committee member of SPACE-1, SPACE-2 and ACST-2. T.R. is funded by grants from the National Institutes of Health (R01 MD012467, R01 NS029993, R01NS040807, 1U24NS107267), and the National Center for Advancing Translational Sciences (UL1 TR002736, KL2 TR002737). J.S.M. has received institutional research grants from Abbott, Cook, Endologix, Gore and Medtronic., (Copyright © 2023 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Significant advances in the field of carotid artery stenting (CAS) have occurred, including new randomized trial data, recent professional societal statements for competency, new techniques and new devices that have been developed, and perhaps most importantly, our understanding of how to better select candidates for CAS to avoid periprocedural complications. The current Centers for Medicare and Medicaid Services coverage decision regarding CAS is outdated, and our review supports our recommendation to approve CAS in selected candidates who are symptomatic with a carotid stenosis ≥50% and ≤99% and for asymptomatic patients with carotid stenosis ≥70% and ≤99% for stroke prevention. Optimized CAS strategies have allowed experienced operators to better assess procedure risk before CAS and have led to continued improvement in CAS outcomes. New technologies including enhanced embolic protection devices and dual-layered stents should result in further improvement., Competing Interests: Funding Support and Author Disclosures Dr Siddiqui is supported by National Institutes of Health/National Institute of Neurological Disorders and Stroke (co-investigator, Grant No. 1R01NS091075 [Virtual Intervention of Intracranial Aneurysms]; co-principal investigator, Grant No. R21 NS109575-01 [Optimizing Approaches to Endovascular Therapy of Acute Ischemic Stroke]). Dr Gray has served as a consultant for and received research support from Contego. Dr Heck has served as a consultant for Stryker. Dr Jovin has served as an advisor for, has been an investor in, or owns stock in Route92, Methinks, Galaxy, Viz.ai, Anaconda, and FreeOx Biotech; has served as a consultant for Cerenovus and Contego Medical; and has received grant support from Medtronic and Stryker Neurovascular. Dr Lyden has served as a consultant for Endologix, PQ Bypass, Boston Scientific, Medtronic, BD, Penumbra, and VIVA Physicians; has served as a board member for and received departmental research study support from Endologix, Gore, BD, Bolton, Abbott, Penumbra, Boston Scientific, Merit, and Contego Medical; and owns stock options in Centerline Biomedical. Dr Metzger has served as the principal investigator for the C-GUARDIANS, SAPPHIRE WW, and CANOPY CAS trials; and has served as the co-principal investigator for the CONFIDENCE CAS trial; has received symposium and proctor honoraria from Abbott Vascular; and has served on the advisory committee for Boston Scientific. Dr Rosenfield has served as a consultant or on the scientific advisory board for Althea Medical, Angiodynamics, Boston Scientific, Contego, InspireMD, Magneto, Mayo Clinic, Neptune Medical, Philips, Summa Therapeutics, Surmodics, Thrombolex, Terumo, and Truvic; has received institutional grant support from the National Institutes of Health, Abiomed, and Boston Scientific; owns equity interests in Accolade, Access Vascular, Aerami, Althea Medical, Contego, Cruzar Systems, Embolitech, Endospan, InspireMD, JanaCare, Magneto, Orchestra, PQ Bypass, Prosomnus, Shockwave, Summa Therapeutics, Thrombolex, Truvic, and Valcare; and has served as a board member for the National PERT Consortium. Dr Roubin has received from Cook Inc; and owns equity in Inspire MD. Dr Sachar has served as a consultant and advisory board member for Boston Scientific and Medtronic; has received institutional funds for research or clinical trials from Abbott Vascular, Boston Scientific, Bard Peripheral Vascular, Microvention, W.L. Gore and Associates, Medtronic, Terumo, and Veryan; and is a major shareholder of Contego Medical. Dr Siddiqui owns financial interest in, is an investor in, owns stock options, or has ownership in Adona Medical, Amnis Therapeutics, Bend IT Technologies, BlinkTBI, Buffalo Technology Partners, Cardinal Consultants, Cerebrotech Medical Systems, Cerevatech Medical, Cognition Medical, CVAID, Endostream Medical, Imperative Care, Instylla, International Medical Distribution Partners, Launch NY, NeuroRadial Technologies, Neurotechnology Investors, Neurovascular Diagnostics, PerFlow Medical, Q’Apel Medical, QAS.ai, Radical Catheter Technologies, Rebound Therapeutics (purchased 2019 by Integra Lifesciences), Rist Neurovascular (purchased 2020 by Medtronic), Sense Diagnostics, Serenity Medical, Silk Road Medical, Spinnaker Medical, StimMed, Synchron, Three Rivers Medical, Truvic Medical, Vastrax, VICIS, and Viseon; has served as a consultant or on the advisory board for Amnis Therapeutics, Apellis Pharmaceuticals, Boston Scientific, Canon Medical Systems USA, Cardinal Health 200, Cerebrotech Medical Systems, Cerenovus, Cerevatech Medical, Cordis, Corindus, Endostream Medical, Imperative Care, Integra, IRRAS AB, Medtronic, MicroVention, Minnetronix Neuro, Penumbra, Q’Apel Medical, Rapid Medical, Rebound Therapeutics, Serenity Medical, Silk Road Medical, StimMed, Stryker Neurovascular, Three Rivers Medical, VasSol, Viz.ai, and W.L. Gore and Associates; served as the national principal investigator for or on the steering committee of the Cerenovus EXCELLENT and ARISE II trial; the Medtronic SWIFT PRIME, VANTAGE, EMBOLISE and SWIFT DIRECT trials; the MicroVention FRED trial and CONFIDENCE study; the MUSC POSITIVE trial; the Penumbra 3D Separator trial, COMPASS trial, INVEST trial, MIVI neuroscience EVAQ trial; and the Rapid Medical SUCCESS trial. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The authors sought to study the safety and efficacy of the MANTA Vascular Closure Device (VCD), a novel collagen-based technology dedicated to closure of large-bore arteriotomies., Background: Novel transfemoral therapeutic interventions requiring large-bore catheters have become valid minimally invasive options but have inherent access management challenges. To date, no dedicated vascular closure devices exist for large arteriotomies., Methods: A prospective, single-arm clinical investigation enrolling patients who underwent elective percutaneous interventions with large-bore catheters and planned percutaneous arteriotomy closure in 3 European institutions., Results: A total of 50 patients with a mean age of 79.5 ± 8.3 years underwent high-risk percutaneous coronary intervention, balloon aortic valvuloplasty, or transcatheter aortic valve replacement with large-bore catheters sized 12-F to 19-F. MANTA closure was performed by 9 different operators. The 14-F MANTA VCD was deployed in one-third of the overall cohort (16 of 50, 32%), and the 18-F MANTA VCD in the remainder. The MANTA VCD was deployed successfully in all patients. The mean time to hemostasis was 2 min, 23 s. One patient had a major vascular and major bleeding complication with prolonged femoral bleeding that was successfully treated with a covered stent and eventual surgical repair. There were no other access site-related complications., Conclusions: This first multicenter experience demonstrates rapid and reliable hemostasis and low complication rates with the use of the plug-based MANTA VCD for large-bore arteriotomy closure., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)