Health Condition 1: I739- Peripheral vascular disease, unspecified
Conditions
Interventions
Intervention1: CREDENCEâ?¢ BtK: Sirolimus Eluting BioResorbable Peripheral Scaffold System
Control Intervention1: NIL: NIL
Sponsors
Meril Life Sciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Stenotic (greater than 50 percent) or occlusive atherosclerotic disease of the below the knee arteries. 2. Length of lesion less than or equal to 56 milimeter. 3. Reference vessel diameter 2.25â??4.50 milimeter. 4. A maximum of two lesions in one below the knee vessel treated in the study, or in two vessels of two different legs. 5. Symptomatic Critical Limb Ischemia (Rutherford 4 and 5) 6. Life expectancy of greater than 6 months 7. No child-bearing potential or negative pregnancy test within 7 days of the index procedure. 8. Patient willing and able to return at the appropriate followup times for the duration of the study. 9. Patient provision of written patient informed consent that is approved by the ethics committee.
Exclusion criteria
Exclusion criteria: 1. Patient refusing treatment. 2. Reference segment diameter not suitable for available scaffold design. 3. Length of lesion requiring more than one scaffold implantation. 4. Previously implanted stent(s) or PTA at the same lesion site. 5. Lesion lying within or adjacent to an aneurysm. 6. Inflow-limiting arterial lesions left untreated. 7. Patient has a known allergy to heparin, aspirin, or other anticoagulant/antiplatelet therapies or a bleeding diatheses, or is unable, or unwilling, to tolerate such therapies. 8. Patient taking phenprocoumon (Marcumar) 9. Patient history of prior life-threatening contrast medium reaction. 10. Patient currently enrolled in another investigational device or drug trial. 11. Patient currently breastfeeding, pregnant, or intending to become pregnant. 12. Patient mentally ill or retarded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the CREDENCEâ?¢ BtK-1 study is to evaluate safety and performance of the CREDENCEâ?¢ BtK Sirolimus Eluting BioResorbable Peripheral Scaffold System in subject with Critical Limb Ischemia disease due to de novo lesions (length â?¤56mm) in below the knee arteriesTimepoint: Clinical follow-up at post-procedure 1day, 1 month ± 15 days, 6 months ± 28 days, & 12 months ± 28 days, 2 Year ± 28 days, 3 Year ± 28 days, 4 Year ± 28 days, 5 Year ± 28 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| Late Lumen Loss (LLL) as diagnosed at 6-month angiographic follow-upTimepoint: 6 Months | — |
Countries
India
Contacts
Public ContactDr Ashok Thakkar
Holy Family Hospital
Outcome results
None listed