Health Condition 1: null- Paitent with lesions of the above-the-knee femoropopliteal artery due to peripheral artery disease
Conditions
Interventions
Intervention1: Zilver PTX Drug-Eluting Peripheral Stent: The Zilver PTX stent is intended for use in the treatment of symptomatic vascular disease
of the above-the-knee femoropopliteal arteries having
Sponsors
Cook Incorporated
Cook India Medical Devices Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The 6-month event-free survival (EFS), where EFS means freedom from procedure- or device- related major adverse events (death, amputation of the study limb due to target lesion restenosis, clinically driven target lesion revascularization, target limb ischemia requiring surgical intervention due to target lesion restenosis, or surgical repair of the target vessel due to target lesion restenosis).Timepoint: 6 months follow up | — |
Secondary
| Measure | Time frame |
|---|---|
| N/ATimepoint: N/A | — |
Countries
India
Contacts
Public ContactAbhishek Tyagi
INC Research CDS Services Pvt. Ltd.
Outcome results
None listed