Comparison of RA-IVL and RA-SHP in Calcified Coronary Lesions

Brief summary (registry, in English)

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)

What you commit to

• Study type: Interventional
• Planned participants: 162
• From 1 Jan 2026 to the primary completion date, 31 Dec 2027
• 1 site in 1 country
• Visits and tests: ask the trial team, the registry does not list them

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Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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