NCT02227771Unknown不适用
CONventional Antegrade vs Sub-Intimal Synergy sTENTing in Chronic Total Occlusions
European Cardiovascular Research Center6 个研究点 分布在 1 个国家目标入组 215 人开始时间: 2014年12月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 215
- 试验地点
- 6
- 主要终点
- The primary balloon endpoint is device procedural success
研究概览
简要总结
The purpose of this study is to demonstrate that enhanced vascular healing with the Synergy stent should minimize the risk of late aneurysm formation and potential clinical complications but not at the cost of enhanced efficacy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Male or female patient >18 years old
- •Females of childbearing potential with a negative pregnancy test
- •Presence of Chronic Total Occlusion (CTO) that is known or presumed to be of at least 3 months in duration
- •Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent
- •Attempt to implant at least one Synergy II stent has been made
排除标准
- •Acute myocardial infarction with ongoing ST-elevation
- •Cardiogenic shock
- •Left ventricular ejection fraction <20%
- •Subject has one of the following (as assessed prior to the index procedure):
- •Other serious medical illness (e.g., cancer, congestive heart failure) with estimated life expectancy of less than 24 months Current problems with substance abuse (e.g., alcohol, cocaine, heroin, etc.) Planned procedure that may cause non-compliance with the protocol or confound data interpretation
- •Subject is treated by dialysis or has a baseline serum creatinine level >220 μmol/L (2.5 mg/dL)
- •Known allergy to to contrast (that cannot be adequately premedicated) and/or the trial stent system or protocol-required concomitant medications (e.g., platinum, platinum-chromium alloy, stainless steel, everolimus or structurally related compounds, polymer or individual components, all P2Y12 inhibitors, or aspirin)
- •Subject is participating in another investigational drug or device clinical trial that has not reached its primary endpoint OR subject intends to participate in another investigational drug or device clinical trial within 12 months after the index procedure
- •Need for ongoing long-term anticoagulation
- •Subject has received an organ transplant or is on a waiting list for an organ transplant
- •Subject is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure
- •Planned CABG after the index procedure
- •Subject previously treated at any time with intravascular brachytherapy
- •Subject has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3
- •Subject has a white blood cell (WBC) count < 3,000 cells/mm3
- •Subject has documented or suspected liver disease, including laboratory evidence of hepatitis
- •Subject has a clinically significant bleeding diathesis or coagulopathy or will refuse blood transfusions
- •Subject has had a history of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months
- •Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding
- •Subject has severe symptomatic heart failure (i.e., NYHA class IV)
- •Subject with known intention to procreate within 12 months after the index procedure (women of child-bearing potential who are sexually active must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure)
- •Subject is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential)
结局指标
主要结局
The primary balloon endpoint is device procedural success
时间窗: 1 month
Successful delivery of the Emerge Coronary Dilatation catherter across the lesion and Successful inflation and removal of the Emerge Coronary Dilatation catherter with absences of clinically significant vessel perforation or flow limiting vessel dissection, reduction in thrombolysis in myocardial infarction (TIMI) flow from baseline, clinically significant arrythmias requiring medical treatment or device intervention following dilatation with Emerge balloon and Achievment of final TIMLI 3 flow for the target lesion at the conclusion of the index procedure. The primary balloon endpoint will be evaluated in patients where an attempt to use an Emerge Coronary Dilatation catherter is made.
The primary stent endpoint is 12-month target vessel failure (TVF) rate
时间窗: 12 months
The primary stent endpoint is 12-month target vessel failure (TVF) rate, defined as any ischemia-driven revascularization of the target vessel, MI (Q-wave and non-Q-wave) related to the target vessel or cardiac death.
次要结局
- Acute gain(Peri-procedural)
- In-stent and in-segment %DS(12-Months Post-Index Procedure)
- Target lesion revascularization (TLR) rate(In hospital, 6 Months, 12 Months, 2 Years)
- In-stent and in-segment percent diameter stenosis (%DS)(Peri-procedural)
- In-segment late loss(12-Months Post-Index Procedure)
- Stent, vessel and lumen areas and volumes(Peri-procedural)
- Target lesion failure (TLF) rate(In hospital, 6 Months, 12 Months, 2 Years)
- Target vessel failure (TVF) rate(In hospital, 6 Months, 12 Months, 2 Years)
- Non-cardiac death rate(In hospital, 6 Months, 12 Months, 2 Years)
- All death rate(In hospital, 6 Months, 12 Months, 2 Years)
- Cardiac death or MI rate(In hospital, 6 Months, 12 Months, 2 Years)
- All death or MI rate(In hospital, 6 Months, 12 Months, 2 Years)
- All death/MI/TVR rate(In hospital, 6 Months, 12 Months, 2 Years)
- Target vessel revascularization (TVR) rate(In hospital, 6 Months, 12 Months, 2 Years)
- Cardiac death rate(In hospital, 6 Months, 12 Months, 2 Years)
- Incomplete apposition(12-Months Post-Index Procedure)
- Aneurysm formation(12-Months Post-Index Procedure)
- Stent thrombosis rate (by ARC definitions)(In hospital, 6 Months, 12 Months, 2 Years)
- Myocardial infarction (MI, Q-wave and non-Q-wave) rate(In hospital, 6 Months, 12 Months, 2 Years)
- Angina, dyspnoea and quality of life scores(12 Months)
- In-stent and in-segment minimum lumen diameter (MLD)(Peri-procedural)
- In-stent and in-segment binary restenosis rate(12-Months Post-Index Procedure)
- In-stent and in-segment MLD(12-Months Post-Index Procedure)
- Endothelial strut coverage percentage(12-Months Post-Index Procedure)
研究者
研究点 (6)
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