1. Novel Nitinol Stent for Lesions up to 24 cm in the Superficial Femoral and Proximal Popliteal Arteries: 24-Month Results From the TIGRIS Randomized Trial
- Author
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Christian Loewe, Alexandra J. Lansky, John R. Laird, Jack Chamberlin, Stuart A. Harlin, Scott Schultz, Michael R. Jaff, Thomas Zeller, Aravinda Nanjundappa, Peter Schneider, Frank Bunch, and Richard Begg
- Subjects
Male ,Nitinol stent ,medicine.medical_specialty ,Time Factors ,medicine.medical_treatment ,Self Expandable Metallic Stents ,030204 cardiovascular system & hematology ,Prosthesis Design ,law.invention ,Peripheral Arterial Disease ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,law ,medicine.artery ,Alloys ,medicine ,Humans ,Popliteal Artery ,Radiology, Nuclear Medicine and imaging ,Prospective Studies ,030212 general & internal medicine ,Vascular Patency ,Aged ,business.industry ,Superficial femoral artery ,Endovascular Procedures ,Stent ,Middle Aged ,United States ,Popliteal artery ,Prosthesis Failure ,Surgery ,Europe ,Femoral Artery ,Treatment Outcome ,Female ,Cardiology and Cardiovascular Medicine ,business - Abstract
Purpose: To evaluate the safety and effectiveness of the TIGRIS stent for lesions up to 24 cm in the superficial femoral and proximal popliteal arteries (SFA/PPA). Methods: This prospective, multicenter, randomized study enrolled 274 subjects at 36 sites in the United States and Europe. Subjects were randomly assigned in a 3:1 ratio to treatment with the TIGRIS stent (n=197; mean age 66.7±9.28 years; 141 men) or LifeStent (n=70; mean age 67.9±8.87 years; 49 men). The primary safety endpoint was 30-day freedom from major adverse events (MAE). The primary efficacy endpoint was primary patency at 12 months. Secondary endpoints included target lesion revascularization (TLR) and stent fracture. Clinical success and quality of life were also assessed. Results: Mean lesion length (107.6 vs 117.9 mm, p=0.29), procedure success (99.5% vs 97.1%, p=0.17), and freedom from MAE (99.5% vs 100%, p>0.99) were similar for the TIGRIS and control groups, respectively. Likewise, there was no difference in primary patency at 12 months (60.6% vs 63.2%, p=0.73) or 24 months (56.3% vs 50.2%, p=0.60) or in TLR at the same time points (76.6% vs 80.6%, p=0.49; 70.5% vs 67.2%, p=0.85). There were no differences in the changes in Rutherford category or the ankle/brachial index through 24 months. The rate of stent fracture was lower for TIGRIS compared with LifeStent (0% vs 32.7%, p
- Published
- 2017
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