title: The use of the GORE® TIGRIS® Vascular Stent with dual component design in the superficial femoral and popliteal arteries at 6 months.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Center for Vascular Medicine Angiology and Vascular Surgery, Park Hospital Leipzig, Leipzig, Germany - piorkowski.michael@gmail.com.
authors.forename: M
authors.initials: M
authors.lastname: Piorkowski
authors.forename: B
authors.initials: B
authors.lastname: Freitas
authors.forename: A
authors.initials: A
authors.lastname: Schmidt
authors.forename: S
authors.initials: S
authors.lastname: Bräunlich
authors.forename: M
authors.initials: M
authors.lastname: Ulrich
authors.forename: J
authors.initials: J
authors.lastname: Schuster
authors.forename: Y
authors.initials: Y
authors.lastname: Bausback
authors.forename: M
authors.initials: M
authors.lastname: Werner
authors.forename: D
authors.initials: D
authors.lastname: Scheinert
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000497:Alloys; D015901:Angiography, Digital Subtraction; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation*; D055109:Ankle Brachial Index; D003251:Constriction, Pathologic; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D006801:Humans; D053208:Kaplan-Meier Estimate; D035002:Lower Extremity / Q000098:blood supply*; D008297:Male; D008875:Middle Aged; D058729:Peripheral Arterial Disease / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D011150:Popliteal Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D011237:Predictive Value of Tests; D011474:Prosthesis Design; D012189:Retrospective Studies; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D018616:Ultrasonography, Doppler, Duplex; D014654:Vascular Patency
chemical_list: D000497:Alloys; C013616:nitinol