To assess safety and performance of Melangeâ?¢ BRS Sirolimus Eluting BioResorbable Peripheral Scaffold System for Percutaneous Transluminal Renal Angioplasty of atherosclerotic new or restenotic lesion of the renal artery
- Conditions
- Health Condition 1: I701- Atherosclerosis of renal artery
- Registration Number
- CTRI/2017/10/010120
- Lead Sponsor
- Meril Life Sciences Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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.
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 <=25%.
12. Subject is normotensive or has adequate control of hypertension (SBP <140 mmHg and DBP <90 mmHg) utilizing diet control and/or medication regimen involving only one antihypertensive medication.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Major Adverse Events (MAEs) <br/ ><br>2. Ischemic driven Target Lesion Revascularization (TLR) <br/ ><br>Timepoint: 1 month, 6 months,12 months, 2 years, 3 years, 4 years and 5 years
- Secondary Outcome Measures
Name Time Method 1.Acute device success: <br/ ><br>2. Acute Procedure Success: <br/ ><br>Attainment of a final result of 30% residual stenosis, as determined by the <br/ ><br>Angiographic Core Lab. <br/ ><br>3. Acute Clinical Success: Procedure success without Major Adverse Events (MAE) or access site event requiring <br/ ><br>surgical or percutaneous intervention prior to hospital discharge. <br/ ><br>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