Health Condition 1: I708- Atherosclerosis of other arteries
Conditions
Interventions
Intervention1: Promesa DES-1: Promesa DES-1 is a sirolimus eluting self expandable nitinol peripheral stent system indicated for superficial femoral artery (SFA) and Iliac artery lesions
Control Inter
Sponsors
Meril Life Sciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age >=18 years 2. Patient is willing to provide informed consent and comply with the requirement of protocol and follow up visits 3. Patient agrees not to participate in any other investigational or invasive clinical study for a period of 2 years from the date of index procedure 4. Clinically, all patients must be in Rutherford category 2 to 5. 5. Degree of stenosis >=70% by visual angiographic assessment . 6. Reference vessel diameter between 5.00 mm to 7.00 mm for SFA and 7.00 mm to 10.00 mm for iliac artery. 7. One identifiable single de novo or a series of multiple adjacent lesions in the blocked or narrowed target arteries due to Peripheral Artery Disease (PAD). 8. Total lesion length (or series of lesions) >=20 mm and reference vessel diameter between 5.00 mm to 7.00 mm for SFA and >=20 mm and to 10.00 mm for iliac artery. 9. Patent infrapopliteal and popliteal artery, i.e., single vessel runoff or better with at least 1 of 3 vessels patent ( foot with no planned intervention
Exclusion criteria
Exclusion criteria: 1. Target vessel with in-stent restenosis 2. Prior surgery of the SFA and iliac artery in the target limb to treat atherosclerotic disease 3. History of major amputation 4. Patients with known hypersensitivity to nickel-titanium or investigational stent system including polymer or other individual components, contrast dye or any study-required medications (e.g. antiplatelets, anticoagulants, thrombolytics etc)Uncorrected bleeding disorders 5. Patients with known allergies or sensitive to sirolimus 6. Severe renal insufficiency (serum creatinine >2.0 mg/dL) and cannot withstand CO2 angiography 7. Receiving dialysis or immunosuppressant therapy 8. Patients actively participating in another device or drug study 9. Septicemia at the time of the index procedure 10. Aneurysm of the target artery 11. Pregnant or breast feeding women or plan to become pregnant in the next 2 years 12. Major surgical procedures within 30 days prior to this study or planned within 30 days of entry into this study. 13. Patients who have life expectancy less than 2 years. 14. Use of atherectomy, laser, or other debulking devices in the SFA during the index procedure 15. Poor aortoiliac or common femoral inflow (defined by the presence of hemodynamically significant lesions in the aorta, iliac arteries, or common femoral arteries) 16. History of myocardial infarction (MI) or stroke/cerebrovascular accident(CVA) within 6 months prior to randomization/enrollment 17. Presence of other hemodynamically significant outflow lesions in the target limb requiring intervention within 30 days of randomization/enrollment 18. Perforated vessel as evidenced by extravasation of contrast media prior to randomization/enrollment 19. Persistent, intraluminal thrombus of the proposed target lesion postthrombolytic therapy 20. Heavily calcified lesions 21. Any medical condition which in investigatorâ??s opinion may interfere with patientâ??s participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Major Adverse Events (MAE) 2. Primary PatencyTimepoint: Time Frame: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| All cause of deathTimepoint: Time Frame: Post-procedure, 1 month (±7 days), 6 months (±28 days), 12 months (±28 days), and 24 months (±28 days);Change in Rutherford ClassificationTimepoint: Time Frame: Baseline,1 month (±7 days), 6 months (±28 days),12 months (±28 days) and 24 months (±28 days);Clinically driven TLR (CD-TLR)Timepoint: Time Frame: Post-procedure, 1 month (±7 days), 6 months (±28 days), 12 months (±28 days), and 24 months (±28 days);Hemodynamic ImprovementTimepoint: Time Frame: Baseline, 1 month (±7 days), 6 months (±28 days), 12 months (±28 days) and 24 months (±28 days);Major Adverse Events (MAE)Timepoint: Time Frame: 30 days and 12 months;Primary PatencyTimepoint: Time Frame: 12 months (±28 days);Procedural SuccessTimepoint: Time Frame: Post-procedure;Target limb amputationTimepoint: Time Frame: Post-procedure, 1 month (±7 days), 6 months (±28 days), 12 months (±28 days), and 24 months (±28 days);Technical SuccessTimepoint: Time Frame: index procedure;User Rating on Technical PropertiesTimepoint: Time Frame: Index procedure;Walking Impairment Questionnaire (WIQ)Timepoint: Time Frame: 1 month (±7 days), 6 months (±28 days), 12 months (±28 days) and 24 months (±28 days) | — |
Countries
India
Contacts
Public ContactDr Ashok Thakkar
Meril Life Sciences Pvt. Ltd.
Outcome results
None listed