The COMPETE-LM Trial: A Physician-initiated Randomized Clinical Trial (RCT) Comparing Conventional Provisional Stenting With Drug-coated Balloon-enhanced Provisional Stenting for the Treatment of Complex Left Main (LM) Coronary Artery Disease.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 186
- 主要终点
- Angiography-based late lumen loss
研究概览
简要总结
Prospective, physician-initiated, multicenter, randomized, single-blind, controlled trial.
Participants will be randomized (1:1) to a DCB-enhanced strategy (study group) or a conventional strategy (control group).
The study aims to compare the clinical outcomes of conventional provisional stenting (Angiolite in the main branch, with optional side branch stenting if compromised) versus DCB enhanced provisional stenting (Angiolite in the main branch plus Essential Pro in the side branch) in patients with complex left main bifurcation stenosis indicated to receive non-urgent percutaneous coronary intervention (PCI).
Target lesions, both main vessel and side branch, will be treated using iVascular devices, with patients randomized into two arms. In one arm, treatment will be performed exclusively with the Angiolite sirolimus-eluting stent (Angiolite, iVascular) in the main vessel, while in the other arm, the Angiolite will be used in the main vessel and the Essential Pro paclitaxel drug-eluting balloon (Essential Pro, iVascular) in the side branch. Non-target lesions may be treated with any commercially available devices according to their approved indications.
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
- •Distal left main stem bifurcation stenosis type Medina 1,1,1 or 0,1,1 with indication for revascularization.
- •Left main diameter ≤6.00 mm.
- •LAD and LCx diameter both >2.75 mm, evaluated by visual estimation.
排除标准
- •Subjects with ages 18 or below at the time of the procedure.
- •Female subjects who may be pregnant or breast-feeding at the time of the procedure.
- •Previous PCI of the left main bifurcation.
- •Chronic total occlusion of the LAD or LCx.
- •Trifurcating left main requiring treatment of the 3 branches.
- •LAD and LCx reference sizes are out of the sizing ranges of the used DES/DCB families.
- •In-stent restenosis as target lesion.
- •Previous coronary artery bypass graft (CABG) with any patent graft on the left coronary system.
- •ACS-STEMI (ST-Segment Elevation Myocardial Infarction) due to LM disease.
- •Cardiogenic shock.
- •Left ventricular ejection fraction below 35%.
- •Decision to use mechanical circulatory support for protected PCI.
- •Contraindication to a minimum of 3 months double antiplatelet and long-term single antiplatelet therapy (or adapted, in case of indication for anticoagulation).
- •Associated significant valvular disease.
- •Renal insufficiency with glomerular filtration rate (GFR) <
- •Life expectancy less than one year.
研究组 & 干预措施
Conventional Stenting
Angiolite, iVascular
干预措施: Angiolite Sirolimus-Eluting Stenting (Device)
DBC-enhanced Stenting
Essential Pro, iVascular
干预措施: Essential Pro Paclitaxel Drug-Eluting Balloon (Device)
结局指标
主要结局
Angiography-based late lumen loss
时间窗: 12 months post procedure
Angiography-based late lumen loss at the level of treated side-branch (primarily not stented branch)
次要结局
- 2. Late lumen loss(at 12 months post procedure)
- Stent thrombosis rate(at 12 months post procedure)
- Optical coherence tomography (OCT)-based minimal stent / lumen area(at 12 months post procedure)
- OCT-based area stenosis(at 12 months post procedure)
- Acute lumen gain (2D)(at index procedure)
- Acute lumen gain (3D)(at index procedure)
- Acute functional result(at index procedure)
- Functional result in the LAD and in the LCx(at 12 months post procedure)
- Delta μQFR in the LAD and in the LCx(at index procedure and at12 months post procedure)
- Malposition rate(at 12 months post procedure)
- Underexpansion rate(at 12 months post procedure)
- Diameter stenosis(at 12 months post procedure)
- Area stenosis(at 12 months post procedure)
- Conversion rate(at index procedure)
- Procedure time(at index procedure)
- Used contrast media(at index procedure)
- Radiation dose(at index procedure)
- Composite of death, myocardial infarction, target vessel revascularization, hospitalization for heart failure(at 6 months and 12 months pos procedure)
- Death(from index procedure to 12 months post procedure)
- Myocardial Infarction(from index procedure to 12 months post procedure)
- Target vessel revascularization(from index procedure to 12 months post procedure)
- Hospitalization for heart failure(from index procedure to 12 months post procedure)