CTRI/2024/07/069702招募中不适用
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.
Advanced MedTech Solutions Private Limited3 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年7月10日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Composite Endpoint
研究概览
简要总结
An Observational Registry Study of Advapro Coronary Stent System in Coronary Artery Diseased Patients of Indian and European Population. The study will include 120 patients, out of which 80 patients will be enrolled in India and 40 patients will be enrolled in Europe. A QCA Analysis will be performed on minimum 48 patients in Indian population only.
All patients will be followed up till 1 year after the index procedure.
Primary Objective:
- To evaluate the performance of AdvaPro Sirolimus Eluting Stent follow up indicated by MACE at 9 months.
Secondary Objectives:
-
To estimate patient safety and performance through incidence of Major Adverse Cardiac Events (MACE) at 30, 180, 360 days.
-
To Estimate Definitive parameters of performance of AdvaPro Sirolimus Eluting Stent as defined by Late Lumen Loss and Diameter Stenosis percentage at 270 days of AdvaPro Sirolimus Eluting Stent.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Greater than 18 years.
- •All (Males, Females, Transgenders, Non-binary).
- •Patient or legally authorized representative (LAR) agrees to participation by signing the informed consent form.
- •Patient with coronary artery disease Eligible for percutaneous coronary intervention (PCI).
- •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.
- •Patients with Reference vessel diameter of 2.5 to 3.50 mm.
- •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.
结局指标
主要结局
Composite Endpoint
时间窗: 1 Year
MACE (Hierarchical incidence of Cardiovascular Death, Myocardial infarction or Target Vessel Revascularization)
时间窗: 1 Year
次要结局
- Incidence of DOCE(Cardiovascular Death)
- Incidence of POCE(All cause death)
- Incidence of MACE(Cardiovascular Death)
- Target vessel failure (TVF)(30 Days, 180 Days, 270 Days and 360 days)
- Non-Target Vessel related Myocardial Infarction(30 Days, 180 Days, 270 Days and 360 days)
- Stent thrombosis(Stent thrombosis as per)
- Device success(Residual coronary stenosis less than 20 percent)
- Procedural Success(Residual Stenosis less than 20 percent)
- Acute Device Success(Acute Device Success as defined by Residual Stenosis less than or equal 20 percent)
- For QCA Group(Late Lumen Loss)
研究者
Dr Jayesh Jani
Advanced MedTech Solutions Private Limited
研究点 (3)
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