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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: doctor_ye@126.com
• Phone: 18951670287

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.