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)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 主要终点
- Composite Endpoint
研究概览
简要总结
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.
To evaluate the performance of AdvaPro Sirolimus Eluting Stent follow up indicated by MACE at 9 months.
Of the 120, 40 patients will be assigned to European population and 80 patients will be assigned to Indian population. QCA is applicable for only in sub-strategy participants at baseline and 9 month follow-up visit.
A QCA Analysis will be performed on minimum 48 patients in Indian population only.
Interval(Days) for patients visit at Day 0, Day 30±6, Day 180±8, Day 270±10 and Day 360±14.
详细描述
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).
A QCA Analysis will be performed on minimum 48 patients in Indian population only at baseline visit and 9 month follow-up.
Interval(Days) for patients visit at Day 0, Day 30±7, Day 180±8, Day 270±10 and Day 360±14.
Sample size distribution:
Of the 120, 40 patients will be assigned to European population and 80 patients will be assigned to Indian population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years
- •Gender : All (Males, Females, Transgenders, Non-binary)
- •ICF : Patient or legally authorized representative (LAR) agrees to participation by signing the informed consent form.
- •Condition - Clinical : Patient with coronary artery disease Eligible for percutaneous coronary intervention (PCI)
- •Condition - Angiographic : Patient with coronary artery disease having one or more de novo stenosis lesion in two native coronary artery with a visually estimated diameter stenosis ≥70%
- •Condition - Angiographic : Patients with Reference vessel diameter of 2.5 ~ 3.50 mm
- •Condition - Angiographic : Patients with lesion length ≤ 36 mm
排除标准
- •Ethical : Pregnant and lactating females
- •Patients requiring staged procedure
- •Condition : Known congestive heart failure (NYHA IV) or left ventricular ejection fraction (LVEF) <30%
- •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
- •Condition : Current medical condition with a life expectancy of less than 12 months
- •Condition : Diagnosis: Acute Myocardial Infarction within 72 hours of Planned Index procedure
- •Condition : Patient has current unstable arrhythmias
- •Procedural : Patients previously treated with PCI or CABG for any coronary artery lesion revascularization
- •Procedural : Patients with Chronic Total Occlusion in two or more vessels
- •Procedural : Patients with Ostial lesions (within 5.0mm of vessel origin).
- •Procedural : Patients with Bifurcation lesions that include a side branch >2.0 mm diameter
- •Procedural : Unprotected Left Main Coronary Artery lesion
- •Condition : Heavily calcified lesion and/or calcified lesion which cannot be successfully predilated in opinion of the treating cardiologist
- •Condition : Patients with Cardiogenic shock, systemic bleeding and coagulation disorders, intracranial bleeding, Renal insufficiency requiring dialysis, Acute or chronic renal function (serum creatinine >2.0mg/dl or 150 µmol/L), peripheral vascular diseases, cancer, etc. and patients who are planning to undergo surgery within 1 year of the index procedure
- •Condition : Patients with platelet count <100.000 cells/mm3 or >700.000 cells/mm3 or a WBC <3.000 cells/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)
次要结局
- Incidence of MACE(30 Days, 180 Days and 360 days)
- Stent thrombosis(0-24 hours, 24 hours-30 days and late 30-365 days)
- Incidence of POCE(30 Days, 180 Days, 270 Days and 360 days)
- Procedural Success(24 Hours)
- Acute Device Success(24 Hours)
- Device success(0 hour, 24 hours, 3 days)
- Non-Target Vessel related Myocardial Infarction(30 Days, 180 Days, 270 Days and 360 days)
- Incidence of DOCE(30 Days, 180 Days, 270 Days and 360 days)
- Target vessel failure (TVF)(30 Days, 180 Days, 270 Days and 360 days)