CTRI/2025/05/087739招募中不适用
A Prospective, MuLticenter, Clinical Study to Evaluate tHe Safety and Performance of the Eternia-AB-EveroliMus Eluting Coronary Stent SYstem (EEECSS-Eternia-AB) implanted as a part of standard clinical practice in Indian patients (ALCHEMY-AB)
Innvolution Healthcare Private Limited5 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2025年6月9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
- 270
- 试验地点
- 5
- 主要终点
- Composite end point at 9 months follow-up indicated by Major Adverse Cardiac Events (MACE) defined as hierarchical incidence of Cardiovascular Death, Myocardial infarction or Target Vessel Revascularization.
研究概览
简要总结
It is a prospective, multicentric clinical study to evaluate the safety and performance of Eternia-AB Everolimus Eluting Coronary Stent System implanted as a part of standard clinical practice in Indian patients
The study will include 270 patients, out of which 60 patients will be enrolled in the QCA (Quantitative Coronary Angiography) sub-study.
All patients will be followed up till 1 year after the index procedure.
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
- •More than 18 years.
- •Males or non-pregnant females.
- •Patient or legally authorized representative (LAR) agrees to participation by signing the informed consent form.
- •Patient with coronary artery disease undergoing percutaneous coronary intervention (PCI) with Eternia-AB Everolimus Eluting Coronary Stent System only.
- •Patient with coronary artery disease having one or more de novo stenosis lesion in native coronary artery with a visually estimated diameter stenosis ≥70%.
- •Patients with Reference vessel diameter of 2.0 to 4.50 mm.
- •Patients with lesion length ≤ 52 mm.
排除标准
- •Female patients with known pregnancy or who are lactating.
- •Patients requiring staged procedure.
- •Known congestive heart failure NYHA IV or left ventricular ejection fraction LVEF less than 40 percent.
- •Patients with known hypersensitivity or allergies to aspirin, heparin, clopidogrel, ticlopidine, Everolimus or similar drugs, or any other analogue or derivative, cobalt, chromium, nickel, molybdenum or contrast media.
- •Current medical condition with a life expectancy of less than 12 months.
- •Acute Myocardial Infarction within 72 hours of Planned Index procedure.
- •Patient has current unstable arrhythmias.
- •Patients previously treated with PCI or CABG for any coronary artery lesion revascularization.
- •Patients with Chronic Total Occlusion in two or more vessels.
- •Patients with Bifurcation lesions that include a side branch greater than 2.0 mm diameter.
- •Unprotected Left Main Coronary Artery lesion.
- •Patients with Cardiogenic shock, systemic bleeding and coagulation disorders, intracranial bleeding, Renal insufficiency requiring dialysis, Acute or chronic renal function serum creatinine greater than 2.0mg/dl or 150 mol/L, peripheral vascular diseases, cancer, etc.
- •and patients who are planning to undergo surgery within 1 year of the index procedure.
- •Patients with platelet count less than 100.000 cells/cubic millimetre or greater than 700.000 cells/cubic millimetre or a WBC less than 3.000 cells/cubic millimetre.
结局指标
主要结局
Composite end point at 9 months follow-up indicated by Major Adverse Cardiac Events (MACE) defined as hierarchical incidence of Cardiovascular Death, Myocardial infarction or Target Vessel Revascularization.
时间窗: 270 days
次要结局
- Procedural success:(• Residual Stenosis less than 20%)
- Incidence of DOCE(• Cardiovascular Death)
- Incidence of POCE(• All cause death)
- Incidence of MACE(• Cardiovascular death)
- Target vessel failure (TVF)(30 Days)
- Non-Target Vessel related Myocardial Infarction(30 Days)
- Stent thrombosis as per(a. Academic Research Consortium- 2 [ARC-2] Evidence definitions – Definite and probable)
- Device success:(•Residual coronary stenosis less than 20 %)
- QCA Endpoint(• Late Lumen Loss)
研究者
Dr Pravin K Goel
Medanta Hospital
研究点 (5)
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