Comparing super high-pressure balloon and intravascular lithotripsy to prepare severely calcified coronary arteries

Super High-pressure Balloon Versus Intravascular Lithotripsy to Prepare Severely Calcified Coronary Lesions: a Randomized Controlled Trial (Shape)

This trial tests whether a super high-pressure balloon works as well as intravascular lithotripsy to prepare severely calcified coronary lesions in adults getting drug-eluting stents.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 78 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Nanjing First Hospital, Nanjing Medical University (other)
• Locations: 3 sites (Lianyungang, Jiangsu and 2 other locations)
• Trial ID: NCT07093788 on ClinicalTrials.gov

What this trial studies

This is a randomized interventional trial comparing two lesion-preparation techniques—super high-pressure balloon dilation versus intravascular lithotripsy (IVL)—for severely calcified de novo coronary lesions. Participants undergo intravascular imaging with optical coherence tomography (OCT) or intravascular ultrasound (IVUS) before and after preparation and after stent implantation to quantify stent expansion and plaque modification. The trial measures procedural success, imaging-based stent expansion, and safety outcomes such as procedural complications and target lesion failure. The goal is to determine whether the lower-cost balloon approach provides similar mechanical results and safety compared with IVL in vessels 2.5–4.5 mm.

Who should consider this trial

Good fit: Adults 18–80 years old with de novo severely calcified coronary lesions (maximum calcium arc ≥270° on OCT/IVUS) who need drug-eluting stent implantation and have inadequate lesion modification with a non-compliant balloon are the ideal candidates.

Not a fit: Patients with acute ST-elevation myocardial infarction, lesions that do not meet the severe calcification criteria, vessels outside the 2.5–4.5 mm range, or those ineligible for DES implantation are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the trial could identify a simpler and less costly way to achieve better stent expansion and lower complication risk in patients with heavily calcified coronary lesions.

How similar studies have performed: Prior IVL trials (DISRUPT series) have shown IVL to be safe and effective for a range of severe calcifications while smaller studies suggest super high-pressure balloons can achieve comparable final stent expansion, but direct head-to-head data are limited.

Eligibility criteria

Inclusion Criteria:

* Age \> 18 years and \< 80 years
* Presented as asymptomatic angina, stable angina, unstable angina, prior myocardial infarction (MI), or non-ST-elevation myocardial infarction (NSTEMI).
* Have an indication for drug-eluting stent (DES) implantation
* Denovo coronary artery calcified lesions
* Target lesion diameter stenosis ≥ 70%, or target lesion diameter stenosis between ≥ 50% and \< 70%, accompanied by evidence of myocardial ischemia(such as fractional flow reserve (FFR) ≤ 0.80 or minimal lumen area (MLA) ≤ 4.0 mm²).
* Reference vessel diameter of the target vessel between 2.5 mm - 4.5 mm
* Maximum calcium arc within the lesion ≥ 270⁰ assessed by optical coherence tomography (OCT) or intravascular ultrasound (IVUS)
* Unsatisfactory lesion preparation with non-compliant balloon, defined as baseline diameter stenosis reduction of \< 30% under maximal inflation pressure.
* Provision of written informed consent

Exclusion Criteria:

* Presented as acute ST-segment elevation myocardial infarction (STEMI), cardiogenic shock and multiple organ failure
* Presented as severe contrast agent allergy
* Intolerant to dual antiplatelet therapy (DAPT) and/or anticoagulation therapy
* Presented as active phase of autoimmune disease
* Calcified nodules or eccentric calcification lesions
* Failure to reach the target lesion with guidewires or catheters
* Complex coronary bifurcation lesions
* Target vessel thrombosis or aneurysm within 10 mm of the target lesion

Where this trial is running

Lianyungang, Jiangsu and 2 other locations

• Lianyungang First People's Hospital — Lianyungang, Jiangsu, China (RECRUITING)
• Nanjing First Hospital — Nanjing, Jiangsu, China (RECRUITING)
• Yixing People's Hospital — Yixing, Jiangsu, China (RECRUITING)

Study contacts

• Principal investigator: Fei Ye, MD — The First Affiliated Hospital with Nanjing Medical University
• Study coordinator: Fei Ye, MD

Conditions: PCI, Coronary Arterial Disease, Calcified Coronary Lesions, super high-pressure balloon, percutaneous coronary intervention, intravascular lithotripsy