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The Journal of Cardiovascular Surgery 2013 August;54(4):447-53

Copyright © 2013 EDIZIONI MINERVA MEDICA

language: English

The use of the GORE® TIGRIS® Vascular Stent with dual component design in the superficial femoral and popliteal arteries at 6 months

Piorkowski M. 1, Freitas B. 1, 2, Schmidt A. 1, Bräunlich S. 1, Ulrich M. 1, Schuster J. 1, Bausback Y. 1, Werner M. 1, Scheinert D. 1

1 Center for Vascular Medicine Angiology and Vascular Surgery, Park Hospital Leipzig, Leipzig, Germany; 2 Vale do Sao Francisco Federal University Petrolina, Brasilia


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Aim: The aim of this study was to collect procedural and clinical data assessing safety and performance of the GORE® TIGRIS® Vascular Stent, a novel dual component stent, made of a nitinol wire frame combined with a fluoropolymer-interconnecting structure.
Methods: This retrospective analysis included 32 consecutive patients (20 men, mean age 72.8 years) with 40 atherosclerotic femoropopliteal lesions (occlusions in 5%) who underwent angioplasty and implantation of a GORE® TIGRIS® Vascular Stent. The patients were scheduled for follow-up at 3, 6 and 12 months after stent implantation for Duplex ultrasound and assessment of Rutherford Becker class (RBC) and Ankle-Brachial Index (ABI)
Results: The mean implanted stent length was 62.3 mm (range 30-100 mm). Procedural success (residual stenosis <30%) was achieved in 100% of the lesions. At 6 months 2 restenosis in 2 patients were observed, resulting in a cumulative primary patency rate (±standard error) of 91.7±8.0%. Between baseline and 6 months the ABI increased from 0.65±0.18 to 0.96±0.12 (P<0.0001) and the median of RBC increased from 3 to 1.5 (P<0.0005). No stent thrombosis was found.
Conclusion: In this retrospective collection of patients all lesions could be successfully treated with this novel hybrid TIGRIS stent. These preliminary results show promising primary patency rates at 6 months. In addition, significant improvements were observed in symptom classification and hemodynamics.

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