An OPen-label, Multicentre, Single Arm, Clinical InvestigatIon to Evaluate PerFormance and safety of RIsoR Crest EveRolimus Eluting Coronary Stent System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 36
- 主要终点
- Target Lesion Failure (TLF) defined as a hierarchical composite of Cardiac Death, target vessel oriented Myocardial infarction (TV-MI) and clinically indicated target lesion revascularization (Ci-TLR) at 360 days following implantation of RisoR Crest Everolimus Eluting Coronary stent.
研究概览
简要总结
This is a single-arm, prospective, multicentre, First Evidence Clinical study to evaluate safety and performance of RisoR Crest Everolimus Eluting Coronary Stent System in Coronary Artery Stenosis in Indian (post market) and European (pre-market) populations. Enrolment of up to 1960 participants (100 QCA +50 OCT) in India and 40 in Europe is planned in the current study. The study will include patients who are planned to undergo PCI with RisoR Crest Everolimus Eluting Coronary Stent System. Patients will be followed up until 1 year post-inclusion at 30, 180, 270, and 360 days. At 270 days, 100 patients enrolled in India in the angiographic sub-group will undergo angiographic follow-up and 50 patients enrolled in the OCT sub-group will undergo OCT follow-up.
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)（—）
入选标准
- •1 Age more than 18 years 2 All Genders (Males, Females, Transgenders, Non binary) 3 Patient or legally authorized representative (LAR) agrees to participate by signing the informed consent form.
- •4 Patient with coronary artery disease eligible for percutaneous coronary intervention (PCI) as per regional or hospitals standard practices guidelines for PCI (For Europe as per ESC guidelines) 5 Patient with coronary artery disease having one or more de nevo or in-stent stenosis lesion in native coronary artery with a visually estimated diameter stenosis more than or equals to 70 percent 6 Patients with Reference vessel diameter of 2.0 to 4.5 mm 7 Patients with lesion length less than 48 mm.
排除标准
- •1 Pregnant and lactating females 2 Candidates for emergency bypass Surgery 3 Patients corresponding to the criteria of a vulnerable population (Vulnerable subjects, including patients who are unable to fully understand all aspects of the investigation, patients who could be manipulated or unduly influenced, patients lacking capacity in the informed consent procedure and patients with dementia and cognitive impairment, patients under social security imprisonment etc) 4 Known congestive heart failure (NYHA IV) or left ventricular ejection fraction (LVEF) less than 30 Percent 5 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 6 Current medical condition with a life expectancy of less than 12 months 7 Patient who have current unstable arrhythmias 8 Patient previously undergone CABG 9 Left Main Coronary Artery lesion 10 Patients with Cardiogenic shock, systemic bleeding and coagulation disorders, intracranial bleeding, Renal insufficiency requiring dialysis, Acute or chronic renal dysfunction (serum creatinine more than 2.0 mg per dl or 150 µmol per L) peripheral vascular diseases, cancer, etc.
- •and patients who are planning to undergo surgery within 360 days of the index procedure 11 Patients with platelet count less than 100000 cells permm3 or more than 700000 cells per mm3 or a WBC less than 3000 cells per mm3.
结局指标
主要结局
Target Lesion Failure (TLF) defined as a hierarchical composite of Cardiac Death, target vessel oriented Myocardial infarction (TV-MI) and clinically indicated target lesion revascularization (Ci-TLR) at 360 days following implantation of RisoR Crest Everolimus Eluting Coronary stent.
时间窗: 360 days
次要结局
- Incidence of TLF (Equivalent of DoCE):(-Cardiovascular Death)
- Incidence of POCE:(-All cause death)
- Incidence of MACE:(-Cardiovascular death)
- Target vessel failure (TVF)(30, 180, 270 and 360 days)
- Non -Target Vessel related Myocardial Infarction(3, 30, 180, 270 and 360 days)
- Stent thrombosis as per(-Academic Research Consortium [ARC] 2 definitions)
- Device success:(-Defined as achievement of a final residual diameter stenosis of less than 20 percent (site - reported), using the assigned device only.)
- procedural success:(-Defined as achievement of a final diameter stenosis of Less than or equal to 20 percent)
- QCA endpoints:(-In-stent and in-segment % diameter stenosis (DS))
- OCT endpoints:(-Diameter Stenosis %)
研究者
Dr Praveen Chandra
Medanta-The Medicity