N/A
N=267
Evaluation of the GORE TIGRIS Vascular Stent
Peripheral Arterial Disease
Bottom Line
View on ClinicalTrials.gov: NCT01576055 ↗Enrolled (actual)
267
Serious AEs
50.9%
Results posted
Oct 2016
Primary outcome: Primary: Primary Safety Endpoint - Number of Participants Free From Major Adverse Events at 30 Days — 187; 69 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- TIGRIS Vascular Stent (Device); BARD LifeStent (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- W.L.Gore & Associates
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Safety Endpoint - Number of Participants Free From Major Adverse Events at 30 Days |
187; 69 | — |
| PRIMARY Primary Efficacy Endpoint - Number of Participants With Primary Patency at 12 Months |
97; 35 | — |
| SECONDARY Number of Participants With Procedural Success |
196; 68 | — |
| SECONDARY Number of Participants With Device Success |
196; 70 | — |
Summary
The primary objective of the randomized study is to evaluate the safety and effectiveness of the TIGRIS Vascular Stent in the treatment of de novo and restenotic atherosclerotic lesions, ≤ 24cm in length, in the superficial femoral and proximal popliteal arteries (SFA/PPA) of patients with symptomatic peripheral arterial disease (PAD).
Eligibility Criteria
Inclusion Criteria
- Rutherford Class 2 - 4.
- Abnormal ankle brachial index (ABI ≤0.9).
- At least 21 years of age.
- Reasonable expectation of survival of at least 12 months after the procedure.
- Male, infertile female, or female practicing an effective method of preventing pregnancy.
- One de novo or restenotic lesion of the SFA/PPA with a cumulative length visually estimated to be ≤24cm
- Arteries with reference vessel diameter of 4.0 - 6.5 mm within the SFA/PPA, estimated visually.
- Angiographic evidence of at least one patent tibial artery (<50% stenosis angiographically).
- Guidewire has successfully traversed the lesion to be treated and is within the true lumen of the distal vessel.
- Lesion has been pre-dilated before stent deployment.
Exclusion Criteria
- Prior enrollment in this study.
- Vascular access/catheterization in the target leg within 30 days of study enrollment.
- Prior treatment of the SFA/PPA in the target leg with stenting or bypass.
- Flow-limiting aortoiliac disease.
- Additional ipsilateral femoropopliteal or tibial disease, outside of the lesion to be stented, requiring intervention.
- Arterial aneurysm in the target leg.
- Co-morbid conditions which would preclude compliance with study protocol.
- Obstructive or occlusive non-atherosclerotic disease.
- Creatinine greater than 2.5 mg/dl.
- Amputation above the metatarsals, resulting from vascular disease, in the target leg.
- Septicemia or uncontrolled infection.
- Contraindication to anticoagulation or antiplatelet therapy, including allergy to heparin, or history of heparin induced thrombocytopenia (HIT), or a positive platelet factor 4 (PF4) antibody assay.
- Abnormal platelet levels, i.e., platelet count at Baseline less than 80,000/microliter.
- History of coagulopathy.
Data sourced from ClinicalTrials.gov (NCT01576055). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.