Comparison of Combined Rotational Atherectomy With Intravascular Lithotripsy Versus Super-High Pressure Balloon Angioplasty for Heavily Calcified Coronary Lesions (CRUSH-CALC Study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- Minimum Lumen Diameter (MLD) assessed by intravascular imaging
研究概览
简要总结
Study Design Prospective, multicenter, single-blind, randomized controlled trial
Hypothesis In patients with severely calcified coronary lesions undergoing rotational atherectomy (Rota), post-rotational lesion optimization using intravascular lithotripsy (IVL) is non-inferior to super high-pressure balloon (SHPB) in terms of final minimal lumen diameter (MLD), with potential differences in acute lumen gain, stent expansion, and periprocedural complications.
Inclusion Criteria
- Age ≥ 18 years
- De novo coronary lesions with severe calcification confirmed by angiography (moderate-to-severe calcification) and IVUS (calcification grade ≥2 by Mintz classification, or IVUS cannot pass)
- Target vessel reference diameter 2.5-4.0 mm
- Lesion length ≤ 30 mm suitable for rotational atherectomy
- Clinical evidence of ischemia (stable or unstable angina, or functional ischemia testing)
- Planned rotational atherectomy with residual calcification grade ≥2 post-Rota (burr ≤1.5 mm), or inadequate expansion with 2.5 mm non-compliant balloon at nominal pressure
- Written informed consent provided
Exclusion Criteria
- Acute myocardial infarction within 7 days
- Presence of thrombus, chronic total occlusion (CTO), or in-stent restenosis in target vessel
- Lesion located in coronary artery bypass graft
- Severe heart failure (LVEF < 30%)
- Previous stenting or rotational atherectomy in same target vessel
- Known contrast allergy, active bleeding, severe comorbidity with life expectancy < 12 months
- Pregnancy or lactation
- Participation in other interventional clinical trials
Randomization
After initial rotational atherectomy (burr ≤1.5 mm), eligible patients meeting imaging-defined "need for further lesion optimization" criteria will be randomized 1:1 to:
Rota + IVL group: Intravascular lithotripsy using pulsed ultrasonic energy (up to 80 pulses, 8 cycles) followed by stent implantation Rota + SHPB group: Super high-pressure balloon (≥30 atm) expansion followed by stent implantation Stratification by: Study center, Reference vessel diameter (2.5-3.0 mm vs. >3.0-4.0 mm)
Primary Endpoint Post-procedural minimal lumen diameter (MLD) measured by OCT/IVUS immediately after stent implantation and post-dilation Secondary Endpoints Procedural efficacy: Acute lumen gain, final stent expansion rate, minimal stent area, stent apposition Procedural safety: Periprocedural complications including coronary perforation, dissection, no-reflow/slow flow, acute stent thrombosis Clinical outcomes: MACE (composite of cardiac death, myocardial infarction, target vessel revascularization) at 30 days, 6 months, and 12 months Other outcomes: Major bleeding (BARC ≥2), acute kidney injury (KDIGO criteria), procedure duration, contrast volume, radiation exposure Sample Size Total: 162 patients (81 per group)
In-hospital monitoring until discharge Clinical follow-up at 30 days, 6 months, and 12 months Imaging follow-up (OCT/IVUS) selectively at designated centers as per protocol or clinical indication
Study Centers
Three tertiary hospitals with extensive experience in complex coronary interventions and calcified lesion management:
- Beijing Chaoyang Hospital, Capital Medical University (coordinating center)
- China-Japan Friendship Hospital
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study Duration January 2026 to December 2028 (3 years)
详细描述
Severely calcified coronary lesions reduce vessel compliance, limit balloon expansion, and impair optimal stent deployment, leading to higher procedural risk. Rotational atherectomy (Rota) can modify superficial calcium but may be insufficient for deep or circumferential calcium. Intravascular lithotripsy (IVL) and super high-pressure balloon angioplasty (SHPB) are both used for additional calcium modification, but direct comparative evidence in the "post-Rota lesion optimization" setting is limited.
This multicenter, prospective, randomized, single-blind trial compares Rota + IVL versus Rota + SHPB for imaging-defined lesion optimization and periprocedural safety in severely calcified de novo coronary lesions, with clinical follow-up through 12 months.
Study design and sites
- Design: Prospective, multicenter, randomized controlled, single-blind trial; 1:1 allocation.
- Sites: Beijing Chaoyang Hospital, Capital Medical University (coordinating center); China-Japan Friendship Hospital; Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
- Study period: January 2026 to December 2028.
- Sample size: 162 participants (81 per group).
- Blinding: Operators are not blinded. Imaging analysts and/or (if applicable) endpoint adjudicators are blinded to treatment allocation.
Core workflow (screening to final imaging)
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
- •Age ≥18 years, able to understand the study purpose and voluntarily sign written informed consent
- •Coronary angiography confirmed severe calcified lesions (Mintz classification ≥Grade 2), with IVUS unable to pass or showing calcification grade ≥2
- •Native coronary artery lesion
- •Target vessel diameter 2.5-4.0mm
- •Lesion length ≤30mm, suitable for rotational atherectomy
- •Clinical indication for PCI: Ischemic cardiomyopathy confirmed by functional testing (e.g., myocardial nuclear scan); Clinical presentation of stable or unstable angina with clear PCI indication
- •Planned rotational atherectomy as initial calcium modification technique
- •After rotational atherectomy (burr diameter ≤1.5mm), IVUS shows calcification grade still ≥2, or <2 but 2.5mm non-compliant balloon cannot achieve adequate expansion at nominal pressure
- •Informed consent signed and agreement to participate in clinical trial
- •Able to comply with treatment and complete follow-up
排除标准
- •Acute myocardial infarction (AMI) within 7 days, as condition may be unstable and increase periprocedural complication risk
- •Target vessel characteristics: Target vessel with thrombus formation, may increase intraoperative embolism risk; Target vessel with chronic total occlusion (CTO), unable to be treated by rotational atherectomy and calcium modification techniques; Target lesion is in-stent restenosis; Target lesion located in coronary artery bypass graft
- •Severe heart failure: left ventricular ejection fraction <30%, poor tolerance to PCI surgery, may increase perioperative mortality risk
- •Previous treatment history: previous stent implantation or rotational atherectomy in the same target vessel, as complex lesion structure or confounding treatment effects may exist
- •Special medical history: Known contrast allergy or severe bleeding tendency (such as active gastrointestinal bleeding), may be unable to tolerate PCI surgery; Patients with other serious comorbidities, expected to be unable to complete 12-month follow-up (such as life expectancy <12 months)
- •Pregnancy or lactation: pregnant or lactating women, as intraoperative radiation and drug effects may adversely affect mother and child
- •Participation in other clinical trials: patients simultaneously participating in other interventional clinical trials, to avoid mutual influence of different trial intervention measures
结局指标
主要结局
Minimum Lumen Diameter (MLD) assessed by intravascular imaging
时间窗: Immediately post-procedure (within 24 hours after PCI completion)
The primary efficacy endpoint is the post-procedural minimum lumen diameter (MLD) measured by intravascular imaging (OCT or IVUS) immediately after stent implantation and final post-dilatation. MLD is defined as the smallest luminal diameter within the treated segment. An increase of ≥0.5mm compared to baseline MLD is considered clinically meaningful improvement. The measurement will be performed by the core imaging laboratory using standardized acquisition and analysis protocols with blinded adjudication.
次要结局
- Major Adverse Cardiovascular Events (MACE) at 6 months(6 months post-procedure)
- Major Adverse Cardiovascular Events (MACE) at 12 months(12 months post-procedure)
- Incidence of acute kidney injury(48-72 hours post-procedure)
- Acute lumen gain assessed by intravascular imaging(Immediately post-procedure (within 24 hours after PCI completion))
- Major Adverse Cardiovascular Events (MACE) at 30 days(30 days post-procedure)
- Final stent expansion rate assessed by intravascular imaging(Immediately post-procedure (within 24 hours after PCI completion))
- Incidence of periprocedural mechanical complications(During procedure and hospital stay (up to 7 days post-procedure))
- Bleeding events according to BARC criteria(30 days post-procedure)
研究者
Lin Zhao
Cheif of Cardiovascular department
Beijing Chao Yang Hospital