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

Summary

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)

Conditions

• Vascular Calcification

Interventions

DEVICE

Super High-Pressure Non-Compliant Balloon

The super high-pressure balloon is a non-compliant balloon catheter capable of withstanding inflation pressures up to 35-40 atmospheres. The balloon is sized 1:1 to the reference vessel diameter and positioned across the calcified lesion. Inflation follows a stepwise pressure escalation protocol: 12 atm → 20 atm → 25 atm → 30 atm → 35 atm, with each pressure level maintained for 10-20 seconds. The high-pressure inflation creates controlled fractures in calcified plaque to facilitate subsequent stent deployment and expansion. The device is specifically designed for modification of severely calcified coronary lesions.

DEVICE

Intravascular Lithotripsy System

The intravascular lithotripsy (IVL) system is a balloon-based catheter device that delivers sonic pressure waves to fracture calcium in coronary arteries. The IVL balloon is sized 1:1 to the reference vessel diameter and positioned across the calcified lesion. Once inflated to 4 atm, the system delivers up to 80 pulses of localized pulsatile mechanical energy (50 Hz) to create circumferential and longitudinal calcium fractures in both superficial and deep calcium layers. Each treatment cycle consists of 10 pulses over 10 seconds. The device is specifically designed to modify severe coronary calcification to facilitate stent delivery and expansion.

Sponsors & Collaborators

• China-Japan Friendship Hospital

  collaborator OTHER

• Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

  collaborator UNKNOWN

• Lin Zhao

  lead OTHER

Principal Investigators

• Lin Zhao, Dr · Beijing Chaoyang Hospital, Capital Medical University, Beijing, China

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-01

Primary Completion

2027-12-31

Completion

2028-12-31

Countries

• China

Study Locations