CTRI/2016/11/007473
Completed
Phase 3
A prospective, multicentre and open label clinical study 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. - CREDENCEâ?¢ BtK - 1
Meril Life Sciences Pvt Ltd0 sites30 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: I739- Peripheral vascular disease, unspecified
- Sponsor
- Meril Life Sciences Pvt Ltd
- Enrollment
- 30
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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