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

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)