NCT06089135已完成不适用
Shockwave Lithoplasty Compared to Cutting Balloon Treatment in Calcified Coronary Disease - A Randomized Controlled Trial (Short-Cut)
Baim Institute for Clinical Research22 个研究点 分布在 1 个国家目标入组 413 人开始时间: 2023年12月31日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 413
- 试验地点
- 22
- 主要终点
- Primary Endpoint
研究概览
简要总结
The Short-Cut trial is a prospective, investigator-initiated, multicenter, randomized controlled trial that is designed to compare the efficacy of cutting balloon angioplasty vs. intravascular lithotripsy prior to drug-eluting stent implantation in patients with moderate to severely calcified coronary arteries.
详细描述
The trial will be composed of two cohorts:
- Patients treated with up-front rotational atherectomy
- Patients in whom atherectomy is not planned
Randomization to either cutting balloon angioplasty or intravascular lithotripsy will occur as follows in the 2 cohorts:
- After rotational atherectomy is safely completed In the rotational atherectomy arm
- After safe and successful wire crossing in patients in whom atherectomy is not planned.
The trial is designed to demonstrate non-inferiority between cutting balloon angioplasty and intravascular lithotripsy in each cohort with regards to the primary endpoint of post-procedural stent area as measured by intravascular imaging at the site of maximal calcification.
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
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Subject is > 21 years old
- •Subject with an indication for PCI for the treatment of a) stable coronary artery disease; b) unstable angina; or c) NSTEMI with evidence of down-trending biomarkers
- •Subject is willing and able to provide informed written consent Angiographic Inclusion Criteria
- •The target lesion is a de novo native coronary lesion
- •The target vessel is a native coronary artery with either:
- •A stenosis > 70%; or,
- •A stenosis > 50% and <70% with evidence of ischemia via either positive stress test, FFR value < 0.80 or RFR/iFR/DFR value < 0.89
- •The reference diameter of the target vessel is > 2.5mm and < 4.0 mm at the lesion site
- •The target lesion has evidence of significant calcium at the lesion site defined either as,
- •The presence of radiopacities involving both sides of the arterial wall > 5mm and involving the target lesion on angiography
- •the presence of > 270o arc of superficial calcium on intravascular imaging with a length > 5mm or the presence of 360o arc of superficial calcium
排除标准
- •Patient is pregnant
- •Patient is actively participating in another clinical trial
- •Known LVEF < 25%
- •Ongoing Non-STEMI with rising biomarkers
- •Cardiogenic shock or requirement for mechanical/pharmacologic hemodynamic support
- •Planned use in the randomized lesion of a bare metal stent or non-stent treatment only
- •Patient has a known allergy to contrast which cannot be adequately pre-treated
- •Patient has a history of bleeding or coagulopathy and is unable to receive blood transfusion if needed
- •Patient presents with STEMI
- •Patient is unable to tolerate dual anti-platelet therapy
- •Patient has suffered a recent cerebrovascular event (stroke/TIA) within last 30 days
- •Angiographic Exclusion Criteria
- •Presence of large thrombus in the target vessel
- •Inability to pass coronary guidewire across the lesion
- •The target vessel has excessive tortuosity (Defined as presence of 2+ bends > 90o or 3+ bends > 75o) or other anatomic considerations that precludes intravascular imaging
- •The target lesion is within a coronary artery bypass graft
- •The target lesion involves a bifurcation lesion in which either a 2-stent strategy is planned or both branches are planned for calcium modification
- •Coronary artery disease that requires surgical revascularization
- •Angiographic or imaging evidence of dissection in the target vessel prior to randomization
- •Investigator feels there is not equipoise regarding the treatment strategy
研究组 & 干预措施
Intravascular Lithotripsy
Active Comparator
干预措施: Intravascular Lithotripsy (Device)
Cutting Balloon
Active Comparator
干预措施: Cutting Balloon (Device)
结局指标
主要结局
Primary Endpoint
时间窗: 30 days
Post-procedural stent area at the point of maximum calcification as measured by intravascular imaging
次要结局
- Peri-procedural Myocardial Infarction(within 48 hours of index procedure)
- Procedural Cost(Index procedure)
- Strategy success(Index procedure)
- Procedural success(Index procedure)
- Angiographic success(Index procedure)
- In-hospital MACCE(hospitalization)
- 30 Day MACCE(30 days)
研究者
研究点 (22)
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