Abstract | PURPOSE: To report the immediate and mid-term clinical and anatomical outcomes of a novel, hybrid, heparin-bonded, nitinol ring stent (TIGRIS; Gore Medical) when used for the treatment of lesions located in the popliteal artery. MATERIALS AND METHODS: This was a prospective single-centre registry. Patients eligible for inclusion were individuals suffering from symptomatic popliteal arterial occlusive disease (Rutherford-Becker stage 3-6; P1-P3 segments) and treated with placement of the TIGRIS stent(s). Patients were prospectively scheduled for clinical review and duplex ultrasound follow-up after 6 and 12 months. Outcome measures included immediate technical success, primary vessel patency, in- stent binary restenosis (evaluable by Duplex at 50 % threshold; PSVR > 2.0), freedom from target lesion revascularization (TLR) and amputation-free survival (AFS) estimated by Kaplan-Meier (K-M) survival analysis. Cox proportional-hazards regression analysis was also performed to adjust for confounders and search for independent predictors of outcomes. RESULTS: From August 2012 to March 2014, a total of 54 popliteal TIGRIS stents were implanted in 50 limbs of 48 patients (27 men and 21 women; mean age 76.0 ± 1.7 years). Median Rutherford-Becker stage was five at baseline and 37/50 (74.0%) were chronic total occlusions. Technical success was achieved in all cases (100%). Stented lesion length was 114.2 ± 36.9 mm (range 6-20 cm). Median follow-up was 11.8 ± 0.8 months. After 12 months, primary patency of the TIGRIS stent was 69.5 ± 10.2% with an 86.1 ± 5.9% freedom from TLR and 87 ± 5.0% AFS (K-M estimates). CONCLUSION: The TIGRIS hybrid heparin-bonded nitinol ring stent is a safe and effective endovascular option for complex occlusive disease of the popliteal artery.
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Authors | Aneeta Parthipun, Athanasios Diamantopoulos, Panagiotis Kitrou, Soundrie Padayachee, Narayan Karunanithy, Irfan Ahmed, Hany Zayed, Konstantinos Katsanos |
Journal | Cardiovascular and interventional radiology
(Cardiovasc Intervent Radiol)
Vol. 38
Issue 4
Pg. 846-54
(Aug 2015)
ISSN: 1432-086X [Electronic] United States |
PMID | 25962990
(Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
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Chemical References |
- Alloys
- Anticoagulants
- nitinol
- Heparin
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Topics |
- Aged
- Alloys
- Anticoagulants
(administration & dosage)
- Arterial Occlusive Diseases
(diagnostic imaging, surgery)
- Female
- Follow-Up Studies
- Heparin
(administration & dosage)
- Humans
- Kaplan-Meier Estimate
- Male
- Popliteal Artery
(anatomy & histology, diagnostic imaging, surgery)
- Proportional Hazards Models
- Prospective Studies
- Prosthesis Design
- Radiography, Interventional
- Stents
- Treatment Outcome
- Vascular Patency
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