CTRI/2016/11/007473CompletedPhase 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 enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 30
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
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.
- •11. Patient currently breastfeeding, pregnant, or intending to become pregnant.
- •12. Patient mentally ill or retarded.
Investigators
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