CTRI/2017/10/010120招募中2 期
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 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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.
排除标准
- •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.
研究者
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