A Single Center, Randomized Trial of Treatment Strategies for Obstructive Calcified Coronary Lesions: Efficacy CompariSon of Pre-stenting Atherectomy Versus Scoring ballooN for calcifieD Coronary Lesions Coronary Lesions (ECSPAND)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 主要终点
- Ratio of final in-stent minimum lumen area/reference lumen area
研究概览
简要总结
Design: The proposed study is a randomized study comparing the relative effectiveness of three lesion modification strategies (RA, SBS, or OAS) in the treatment of obstructive CCLs using the change in lumen size measurements (MLA, RLA, MSA and the ratio of MSA/MLA) obtained with IVUS or OCT. Patients will be blinded to treatment assignment for the duration of the study.
Treatment: Patients who are randomized to RA will undergo coronary wiring of the CCL and subsequent advancement of the RA burr. The RA system is performed using standard technique under intravenous infusion of heparin. The atherectomy burr size will be determined by the operator.
Patients who are randomized to OAS will undergo coronary wiring of the CCL and subsequent advancement of the OAS according to the manufacturer's guidelines.
Control: Patients who are randomized to SBS will undergo coronary wiring and balloon inflation with SBS performed by standard technique under intravenous infusion of heparin. SBS will be used according to the AngioSculpt manufacturer's guidelines.
Duration: 30 days follow-up.
The primary trial objective is to determine which of the three treatment strategies for treating calcified coronary lesions (RA, SBS, or OA) is superior for obtaining higher ratio of final in-stent minimum lumen area/reference lumen area, as determined by IVUS or OCT (primary study endpoint).
The secondary objectives are to compare the following:
- Difference in pre- vs. post-treatment minimum lumen area (MLA, lumen area gain), as determined by IVUS or OCT (secondary endpoint)
- Mean final minimal stent area (MSA), as assessed by IVUS or OCT (secondary endpoint)
- Ratio of final in-stent minimum lumen diameter/reference lumen diameter, as determined by quantitative coronary angiography (secondary endpoint)
- Incidence of major adverse cardiac events (death, myocardial infarction, target vessel revascularization) during 30 days of follow-up (secondary endpoints)
- Procedure time, fluoroscopy time, and contrast volume (secondary endpoints)
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Clinical indication for coronary intervention such as ischemic symptoms and/or a positive functional study
- •Found to have a de novo severe calcification (radio opacities noted without cardiac motion on contrast injection, lesion length >15 mm, or presence of >270° calcification on one cross-sectional view of IVUS) in a native coronary artery on fluoroscopy or IVUS
排除标准
- •Subject is currently participating in an investigational device or pharmaceutical treatment protocol
- •Persistent (>10 minutes) hypotension (systolic blood pressure <90 mmHg)
- •Need for revascularization of multiple lesions during the index PCI
- •Unprotected left main (>50%) or equivalent left main disease
- •Non-calcified lesions
- •Chronic total occlusions, extreme lesion tortuosity including Type B/C lesions
- •Severe left ventricular dysfunction (ejection fraction <25%)
- •History of bleeding diathesis or coagulopathy
结局指标
主要结局
Ratio of final in-stent minimum lumen area/reference lumen area
时间窗: Immediately after stenting
IVUS measurement based determination of ratio of final in-stent minimum lumen area/reference lumen area, as determined by IVUS
次要结局
- Contrast volume(Immediately after the end of the interventional procedure)
- Fluoroscopy time(Immediately after the end of the interventional procedure)
- Difference in pre- vs. post-treatment minimum lumen area (MLA, lumen area gain)(Immediately after stenting)
- Mean final minimal stent area (MSA)(Immediately after stenting)
- Procedure time(Immediately after the end of the interventional procedure)
- Ratio of final in-stent minimum lumen diameter/reference lumen diameter(Immediately after stenting)
- Lower incidence of major adverse cardiac events (death, myocardial infarction, target vessel revascularization) during 30 days of follow-up(30 days)
研究者
Emmanouil Brilakis
Director of Cardiac Catheterization Laboratories, Professor of Medicine
North Texas Veterans Healthcare System