CTRI/2011/07/001928进行中（未招募）2 期
BIOTRONIK-Safety And Clinical Performance Of The Drug ElutingOrsiro Stent In The Treatment Of Patients With Single De NovoCoronary Artery Lesions In An INDIAN Population - BIOFLOW INDIA
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- BIOTRONIK AG
- 入组人数
- 120
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
- •Patient has provided a written informed consent
- •2. Patient is ≥ 18 and ≤80 years old
- •3. Single de novo lesion with ≥50% and 100% stenosis in up to 2 coronary arteries
- •4. Patient, target vessel(s) and lesion(s) are eligible for PCI with the Orsiro stent
- •5. The target lesion length is ≤26 mm (assessed either visually or by online QCA) and can be covered by one clinical investigation stent
- •6. The target reference vessel diameter is ≥2.0 mm and ≤ 4.0 mm (assessed either visually or by online QCA)
- •7. Target vessel(s) with TIMI flow ≥2
- •8. Patient is an acceptable candidate for CABG
- •9. Clinical evidence of stable or unstable angina pectoris or documented silent ischemia
- •10. Eligible for DAPT treatment with ASA plus either, Clopidogrel, Prasugrel, Ticlopidineor Ticagrelor
排除标准
- •Pregnant and/or breast-feeding females or females who intend to become pregnant during the time of the clinical investigation
- •2. Evidence of myocardial infarction within 72 hours prior to the index procedure
- •3. Patients with CKMB and/or Troponin levels exceeding the normal range within 24 hours prior to the procedure
- •4. Unprotected Left Main coronary artery disease (stenosis 50%)
- •5. Three-vessel coronary artery disease at time of procedure
- •6. Thrombus in target vessel
- •7. Planned interventional treatment of any non-target vessel within 30 days post-procedure.
- •8. Planned intervention of the target vessels after the index
- •9. Ostial target lesion (within 5.0mm of vessel origin)
- •10. Target lesion involves a side branch 2.0mm in diameter
- •11. Documented left ventricular ejection fraction (LVEF) ≤30%
- •12. Heavily calcified lesion which cannot be successfully pre-dilated;
- •13. Target lesion is located in or supplied by an arterial or venous bypass graft
- •14. The target lesion requires treatment with a device other than the pre-dilatation balloon prior to stent placement (including but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, cutting balloon etc.)
- •15. Known allergies to: Acetylsalicylic Acid (ASA), Heparin, Contrast medium, Sirolimus or drugs similar to Sirolimus (i.e. Everolimus, ABT 578, Biolimus,Tacrolimus); CoCr, PLLA, Silicon Carbide
- •16. Impaired renal function (serum creatinine 2.5mg/dl or 221mol/l, determined within 72 hours prior to intervention)
- •17. Patient is receiving oral or intravenous immunosuppressive therapy (e.g., inhaled steroids are not excluded) or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, but not including diabetes mellitus)
- •18. Proximal or distal to the target lesion located stenosis that might require future revascularization or impede run off
- •19. Life expectancy less than 1 year.
- •20. Planned surgery or dental surgical procedure within12 months after index
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