To evaluate safety and performance of CREDENCEâ?¢ BtK Sirolimus Eluting BioResorbable Peripheral Scaffold System in subjects with Critical Limb Ischemiafollowing Percutaneous Transluminal Angioplasty of below the knee arteries.
- Conditions
- Health Condition 1: I739- Peripheral vascular disease, unspecified
- Registration Number
- CTRI/2016/11/007473
- Lead Sponsor
- Meril Life Sciences Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of the CREDENCE� BtK-1 study is to evaluate safety and performance of the CREDENCE� BtK Sirolimus Eluting BioResorbable Peripheral Scaffold System in subject with Critical Limb Ischemia disease due to de novo lesions (length �56mm) <br/ ><br>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 Outcome Measures
Name Time Method ate Lumen Loss (LLL) as diagnosed at 6-month <br/ ><br>angiographic follow-upTimepoint: 6 Months