Dedicated Branch Stent vs Conventional Stent in Bifurcation Coronary stenosis -A medium term followup
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- ï‚·Major Adverse Cardiac Events (MACE) [Time Frame: 1 Year]
研究概览
简要总结
Bifurcation lesions are common and associated with higher risks of major cardiac events and restenosis after percutaneous coronary intervention (PCI). Treatment requires understanding of lesion characteristics, stent design and therapeutic options. We review the evidence for provisional vs 2-stent techniques. We conclude that provisional stenting is suitable for most bifurcation lesions. We detail situations where a 2-stent technique should be considered and the steps for performing each of the 2-step techniques. We review the importance of lesion preparation, intracoronary imaging, proximal optimization (POT) and kissing balloon inflation
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.The patientmustbegreaterthan euqal 18 years of age.2.True coronary bifurcation greaterthan equal to 50 percentage diameter stenosis in both the main and side branches, belonging to the Medina classes 1,1,1 or 1,0,1 or 0,1,1.3.Patients with de novo bifurcation lesions in native coronary arteries with reference diameter ranging from 2.5 mm to 3.5 mm in the side branch and 2.5 mm to 4.0 mm in main branch4.Patient must agree not to participate in any other clinical trial for a period of two years following the index procedure.
- •5.The patient is willing to comply with protocol specified follow-up evaluations.6.Patient or his or her legally authorized representative if applicable agrees to provide written informed consent as approved by respective Ethics Committee and applicable regulatory authorities.
排除标准
- •1.Patients with hypersensitivity or allergies to aspirin, heparin, clopidogrel, ticlopidine, drug such as Sirolimus Rapamycin or similar drugs or any analogue or derivative, cobalt, chromium, nickel, molybdenum, tungsten or any contrast media.2.Patients in whom anti-platelet and or anticoagulant therapy are contraindicated.
- •3.Angiographic evidence of thrombus.4.Direct stenting of the left main bifurcation 5.Impaired runoff in the treatment vessel with diffuse distal disease.6.A significant greaterthan 50 percentage stenosis proximal to distal to the target lesion.
- •7.Ejection fraction lessthan 30 percentage 8.Patient requiring anticipated rotational atherectomy as per the Investigators judgement.
- •9.Highly calcified lesions in which full stent dilatation may not be possible.10.Patients with totally occluded vessel.11.Target lesion has excessive tortuosity unsuitable for stent delivery and deployment.
- •12.Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon.
- •13.Patient has undergone heart transplant or any other organ transplant or planned to undergo any organ transplant.
- •14.Pregnant or nursing patients or those who plan pregnancy during study period 15.Any condition, which in the Investigators opinion would preclude safe participation of patient in the study.
结局指标
主要结局
ï‚·Major Adverse Cardiac Events (MACE) [Time Frame: 1 Year]
时间窗: ONE YEAR
Major adverse cardiac events are the composite of cardiac death, Target vessel myocardial infarction (TV-MI) and clinically driven target lesion revascularization (CD-TLR) [1]
时间窗: ONE YEAR
次要结局
- Cardiac Death:(30 days , six months , one year ,Two years)
研究者
Dr Sadanand Reddy
ESIC Hospital ,sanath Nagar, Hyderabad