A Randomized Comparison of Conventional Versus Intentional StraTegy in Patients With High Risk PrEdiction of Side Branch OccLusion in Coronary Bifurcation InterVEntion: the CIT-RESOLVE Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 566
- 试验地点
- 1
- 主要终点
- side branch occlusion after main vessel stenting
研究概览
简要总结
The purpose of the present study is to investigate if intentional strategy (a more aggressive side branch protection strategy: elective two-stent or jailed balloon technique) is associated with significant reduction of side branch occlusion rate compared to conventional strategy (provisional two-stent strategy or jailed wire technique) in patients at high risk of side branch occlusion (V-RESOLVE score≥12).
详细描述
- Statistical Design and Analysis.
1.1 Analysis Population(s).
1.1.1 Intent to Treat Population (ITT, primary clinical endpoint only).
The ITT population set will consist of all subjects who signed the written informed consent and are randomized, regardless which strategy was selected.
The primary analysis is a superiority ITT analysis of the primary clinical endpoint, being side branch occlusion after main vessel stenting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical Inclusion Criteria:
- •Subject must be male or nonpregnant female ≥18 years of age and ≤75 years of age;
- •Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia;
- •Subject is eligible for PCI;
- •Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed;
- •Subject is willing to comply with all protocol-required follow-up evaluation.
- •Angiographic Inclusion Criteria:
- •Subjects have coronary bifurcation lesions requiring PCI with stent implantation according to clinical guidelines and/or the operator's judgement;
- •Visually estimated reference vessel diameter (RVD) of target main vessel ≥2.5 mm and ≤4.0 mm;
- •Visually estimated RVD of target side branch ≥ 2.0mm;
- •Coronary anatomy is likely to allow delivery of a study device to the target lesion(s);
- •V-RESOLVE score ≥ 12 points.
排除标准
- •Clinical Exclusion Criteria:
- •Subject has a known allergy to contrast (that cannot be adequately pre-medicated) and/or the trial stent system or protocol-required concomitant medications (e.g., stent alloy, stainless steel, sirolimus, everolimus or structurally related compounds, polymer or individual components, all P2Y12 inhibitors, or aspirin);
- •Planned surgery within 6 months after the index procedure;
- •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 12 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 has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions;
- •Subject is participating in another investigational drug or device clinical trial that has not reached its primary endpoint;
- •Subject intends to participate in another investigational drug or device clinical trial within 12 months after the index procedure;
- •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);
- •Subject with left ventricular ejection fraction < 35%;
- •Subject has preoperative renal dysfunction: serum creatinine>2.0mg/dl (176.82umol/L).
- •Angiographic Exclusion Criteria:
- •Left main lesions;
- •In case of acute myocardial infarction of which the culprit vessel located at the left anterior descending (LAD) artery, the bifurcation lesion (LAD/diagonal branch [RVD>2.5mm]) which is proximal to occluded LAD segment should be excluded.
研究组 & 干预措施
Conventional Strategy
Patients randomized to the conventional strategy group would undergo either jailed wire technique (diameter of side branch<2.5mm and ≥2.0mm) or provisional two-stent strategy (diameter of side branch≥2.5mm).
干预措施: Conventional Strategy (Procedure)
Intentional Strategy
Patients randomized to the intentional strategy group would undergo either jailed balloon technique (diameter of side branch<2.5mm and ≥2.0mm) or elective two-stent strategy (diameter of side branch≥2.5mm).
干预措施: Intentional strategy (Procedure)
结局指标
主要结局
side branch occlusion after main vessel stenting
时间窗: Immediately after the main vessel
The primary endpoint is side branch occlusion, which is defined as any decrease in TIMI flow grade or absence of flow in side branch after main vessel stent well opposed.
次要结局
- Major adverse cardiac events (MACE)(12-month)
- The elevation of biomarkers of peri-procedural myocardial injury (Creatine Kinase-Myocardial Band (CK-MB) and Troponin I)(48h after Percutaneous Coronary Intervention (PCI))