CTRI/2017/10/010120
Recruiting
Phase 2
A prospective, multicentre, open label clinical study to evaluate safety and performance of Melangeâ?¢ BRS Sirolimus Eluting BioResorbable Peripheral Scaffold System for use as an adjunct to Percutaneous Transluminal Renal Angioplasty of atherosclerotic de novo or restenotic lesion of the renal artery - Melangeâ?¢ BRS - 1
Meril Life Sciences Pvt Ltd0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: I701- Atherosclerosis of renal artery
- Sponsor
- Meril Life Sciences Pvt Ltd
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. The Subject is \>18 years of age.
- •2\. Subject and Subjects Physician agree to have the subject return for all requirement contact following study enrollment.
Exclusion Criteria
- •1\. Subject has hypersensitivity or contraindication to device material and its
- •degradants (sirolimus, poly (L\-lactide), poly (DL\-lactide), lactide, lactic
- •acid) and platinum that cannot be adequately pre\-medicated.
- •2\. Subject has known allergy or contraindication to aspirin; or to clopidogrel
- •and prasugrel and ticagrelor; or to heparin and bivalirudin.
- •3\. Subject has known bleeding disorder or hypercoagulable disorder, or will refuse blood transfusions.
- •4\. Subject has suffered a Gastro Intestinal (GI) bleed within 30 days before the index procedure that would interfere with antiplatelet therapy.
- •5\. Subject has renal insufficiency defined as serum Creatinine \>\=2\.5 mg/dl.
- •6\. Subject has any immunosuppressive disorder, access site infection, or
- •acute systemic infection due to any cause.
Outcomes
Primary Outcomes
Not specified
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