CTRI/2024/07/069702尚未招募Unknown
A Prospective, Multicentre, Pilot Study to Evaluate the Safety and Performance of The AdvaPro Sirolimus Eluting CorOnary Stent System in Coronary ARtery Stenosis in Indian and European Population. - RESTORE
Advanced MedTech Solutions Private Limited0 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
- Unknown
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •1. Greater than 18 years.
- •2. All (Males, Females, Transgenders, Non-binary).
- •3. Patient or legally authorized representative
- •(LAR) agrees to participation by signing the
- •informed consent form.
- •4. Patient with coronary artery disease Eligible
- •for percutaneous coronary intervention (PCI).
- •5. Patient with coronary artery disease having one
- •or more de novo stenosis lesion in two native
- •coronary artery with a visually estimated diameter
- •stenosis greater than or equal 70 percent.
- •6. Patients with Reference vessel diameter of 2.5
- •to 3.50 mm.
- •7. Patients with lesion length less than or equal 36 mm.
排除标准
- •1 Ethical- Pregnant and lactating females
- •2 Condition- Patients requiring staged procedure
- •3 Condition- Known congestive heart failure (NYHA IV) or left ventricular ejection fraction (LVEF) less than 30 percent
- •4 Condition- Patients with known hypersensitivity or allergies to aspirin, heparin, clopidogrel, ticlopidine, Sirolimus or similar drugs, or any other analogue or derivative, cobalt, chromium, nickel, molybdenum or contrast media
- •5 Condition- Current medical condition with a life expectancy of less than 12 months
- •6 Condition- Diagnosis: Acute Myocardial Infarction within 72 hours of Planned Index procedure
- •7 Condition- Patient has current unstable arrhythmias
- •8 Procedural- Patients previously treated with PCI or CABG for any coronary artery lesion revascularization
- •9 Procedural- Patients with Chronic Total Occlusion in two or more vessels
- •10 Procedural- Patients with Ostial lesions (within 5mm of vessel origin).
- •11 Procedural- Patients with Bifurcation lesions that include a side branch greater than 2 mm diameter
- •12 Procedural- Unprotected Left Main Coronary Artery lesion
- •13 Condition- Heavily calcified lesion and/or calcified lesion which cannot be successfully predilated in opinion of the treating cardiologist
- •14 Condition- Patients with Cardiogenic shock, systemic bleeding and coagulation disorders, intracranial bleeding, Renal insufficiency requiring dialysis, Acute or chronic renal function (serum creatinine greater than 2 mg per dl or 150 µmol per L), peripheral vascular diseases, cancer, etc. and patients who are planning to undergo surgery within 1 year of the index procedure
- •15 Condition- Patients with platelet count less than 100 cells per mm3 or greater than 700 cells per mm3 or a WBC less than 3 cells per mm3
研究者
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