title: Twelve-month experience with the GORE® TIGRIS® Vascular Stent in the superficial femoral and popliteal arteries.
abstract: OBJECTIVE
  The aim of this paper was to report the continued mid-term follow-up of the first patients world-wide treated with the GORE(®) TIGRIS(®) Vascular Stent, a dual component stent consisting of a nitinol wire frame combined with a fluoropolymer-interconnecting structure.
  
  
  METHODS
  From December 2011 until November 2012, 32 consecutive patients (20 men, mean age 72.8 years) with 40 atherosclerotic femoropopliteal lesions (5% occlusions) 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). Here we report the completed 6-month follow-up and, for the first time, a 12-month follow-up.
  
  
  RESULTS
  The median follow-up was 418 days. During the 12-month follow-up 4 patients died. Restenosis or reocclusion of the stent in this time period was observed in 5 lesions (12.5%), resulting in a cumulative primary patency rate of 85.5±6.0%. The ABI increased pre-interventionally from 0.65±0.18 to 0.91±0.18 (P<0.0001) at the 12-month visit. The median RBC improved from 3 to 1 (P<0.0001). No stent thrombosis related to discontinuation of dual antiplatelet therapy 4 weeks after the index procedure was observed.
  
  
  CONCLUSIONS
  The mid-term follow-up of the dual component GORE(®) TIGRIS(®) Vascular Stent showed promising results with high 12-month primary patency rates after femoropopliteal endovascular interventions. These first clinical data are very promising compared to other stent concepts in the superficial femoral and popliteal artery.
authors.affiliation: Cardioangiological Center Bethanien (CCB) Frankfurt am Main, 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: S
authors.initials: S
authors.lastname: Steiner
authors.forename: S
authors.initials: S
authors.lastname: Botsios
authors.forename: Y
authors.initials: Y
authors.lastname: Bausback
authors.forename: D
authors.initials: D
authors.lastname: Scheinert
authors.forename: A
authors.initials: A
authors.lastname: Schmidt
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000497:Alloys; D015901:Angiography, Digital Subtraction; D017130:Angioplasty / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D055109:Ankle Brachial Index; D003251:Constriction, Pathologic; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D006801:Humans; D008297:Male; D008875:Middle Aged; D058729:Peripheral Arterial Disease / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage; D011150:Popliteal Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D011474:Prosthesis Design; D012008:Recurrence; D012189:Retrospective Studies; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D018616:Ultrasonography, Doppler, Duplex; D014654:Vascular Patency
chemical_list: D000497:Alloys; D010975:Platelet Aggregation Inhibitors; C013616:nitinol