Post-market study of the Zilver PTX Stent in patients with blocked arteries of the leg.
- Conditions
- Health Condition 1: null- Paitent with lesions of the above-the-knee femoropopliteal artery due to peripheral artery disease
- Registration Number
- CTRI/2015/11/006374
- Lead Sponsor
- Cook Incorporated
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 50
1. Symptoms of peripheral arterial disease corresponding to Rutherford
Classification 2-4
2. Stenotic ( >50% diameter stenosis) or occluded lesion of the above-the knee
femoropopliteal artery
3. Reference vessel diameter of 4-7 mm
1. Less than 18 years old
2. Unwilling or unable to sign and date the informed consent
3. Pregnant, lactating, or planning to become pregnant in the next 5 years
4. Unwilling or unable to comply with follow-up schedule
5. Simultaneously participating in another investigational drug or device study in which the follow-up phase for that studyâ??s primary endpoint has not been completed 30 days or more prior to being enrolled in this study.
6. Presence of study limb wound (Rutherford Classification 5-6)
7. Any interventional treatment within 30 days prior to the study procedure
8. Planned surgical or interventional procedure within 30 days after the study procedure
9. Planned procedure involving arterial interventional treatment of the study leg
within 6 months after the clinical study procedure
10. Medical condition or disorder that would limit life expectancy to less than 12
months, or that may cause noncompliance with the study plan or confound the data analysis
11. Known hypersensitivity or contraindication to study products that, in the opinion of the investigator, cannot be adequately pre-medicated; study products include nitinol, paclitaxel, dual antiplatelet therapy, and contrast agent
12. Current systemic or local infection that could affect the study outcomes
13. Previous stent in the target vessel
14. Bypass graft with an anastomosis in the target vessel
15. Myocardial infarction within the last 90 days
16. Is in chronic renal failure, or is on hemodialysis or chronic peritoneal dialysis
17. Uncontrolled or poorly controlled diabetes
18. History of bleeding diathesis or coagulopathy or will refuse blood transfusions
19. History of aortic aneurysm 5 cm (treated or untreated)
20. History of iliac aneurysm 2 cm (treated or untreated).
21. Lesion length 140 mm
22. Untreated stenosis ( 50%) or occlusion of inflow tract (i.e., proximal ipsilateral,
iliofemoral, or aortic lesions). Inflow tract may be treated during the study procedure.
23. Untreated stenosis ( 50%) or occlusion of all runoff vessels (i.e., anterior tibial,
posterior tibial and peroneal). Runoff vessel(s) may be treated during the study
procedure; treatment must be performed prior to treating the target lesion and
result in less than eqal to 30% residual stenosis of at least one runoff vessel.
24. Angiographically-evident thrombus in the target lesion
25. Lesions requiring atherectomy (or ablative devices), cutting balloons, or any
other advanced device to facilitate stent delivery.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The 6-month event-free survival (EFS), where EFS means freedom from procedure- or device- related <br/ ><br>major adverse events (death, amputation of the study limb due to target lesion restenosis, <br/ ><br>clinically driven target lesion revascularization, target limb ischemia requiring surgical <br/ ><br>intervention due to target lesion restenosis, or surgical repair of the target vessel due to <br/ ><br>target lesion restenosis).Timepoint: 6 months follow up
- Secondary Outcome Measures
Name Time Method /ATimepoint: N/A