Health Condition 1: I701- Atherosclerosis of renal artery
Conditions
Interventions
Intervention1: Melange BRS: Sirolimus Eluting BioResorbable Peripheral Scaffold System
Control Intervention1: NIl: NIL
Sponsors
Meril Life Sciences Pvt Ltd
Eligibility
Inclusion 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
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. 7. Subject has other medical illnesses (e.g., cancer, end-stage congestive heart failure) that may cause the subject to be non-compliant with protocol requirements, confound the data interpretation, or is associated with a life expectancy of less than three years. 8. Subject has any medical illnesses that would make them unlikely to respond to treatment (e.g., sickle cell nephropathy/sickle cell disease, scleroderma, arteriolar nephrosclerosis, hemolytic-uremic syndrome and vasculitis). 9. Subject has had a Q-wave MI within 30 days before index procedure. 10. Subject has had a stroke or TIA within 30 days before index procedure. 11. Subject has a history of congestive heart failure and has a previously documented LVEF 12. Subject is normotensive or has adequate control of hypertension (SBP
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Major Adverse Events (MAEs) 2. Ischemic driven Target Lesion Revascularization (TLR) Timepoint: 1 month, 6 months,12 months, 2 years, 3 years, 4 years and 5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Acute device success: 2. Acute Procedure Success: Attainment of a final result of 30% residual stenosis, as determined by the Angiographic Core Lab. 3. Acute Clinical Success: Procedure success without Major Adverse Events (MAE) or access site event requiring surgical or percutaneous intervention prior to hospital discharge. 4. Change in blood pressure: Systolic and diastolic blood pressures will be measured.Timepoint: 1 month, 6 month,12 month , 2 year, 3 year, 4 year and 5 year | — |
Countries
India
Contacts
Public ContactDr Ashok Thakkar
Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute
Outcome results
None listed