High-Pressure Cutting Balloon for Calcified Coronary Lesions in IVUS-Guided DES

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 prospective, multicenter, randomized study compares a high-pressure cutting balloon to a non-cutting balloon in 280 adults with moderate-to-severe calcified coronary lesions eligible for IVUS-guided DES implantation. Participants are randomized 1:1 to receive either the experimental balloon or a conventional balloon, with the primary endpoint being minimal stent area (MSA) measured by IVUS immediately after the procedure. The aim is to determine if the cutting balloon improves safety and efficacy of stent deployment in this calcified population. Trial sites include The First Affiliated Hospital of Xi'an Jiaotong University, with BrosMed Medical Co., Ltd as lead sponsor.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥18 years;
* Patients with coronary artery disease who indicate IVUS-guided drug-eluting stent implantation;
* Moderate-to-severe calcified lesions on coronary angiography;
* Target lesion is a de novo lesion in a native vessel that has not received any prior interventional treatment;
* Target vessel diameter of 2.5-4.0 mm, with guidewire crossing of the target lesion;
* In patients with multiple lesions, only one lesion will be selected as the target lesion in this study. If target and non-target lesions are treated during the same procedure, the target and non-target lesions must be located in different vessel branches; furthermore, the non-target lesion must be treated first, and the target lesion may be treated only after successful revascularization of the non-target lesion without severe angiographic complications;
* Provision of written informed consent.

Exclusion Criteria:

* Life expectancy \<1 year;
* Cardiogenic shock or hemodynamic instability;
* Left main coronary artery disease;
* Chronic total occlusion;
* Bifurcation lesions planned for a "two-stent strategy";
* Active bleeding;
* Known history of allergy to contrast media or metals;
* Patients with a bleeding tendency, contraindications to antiplatelet or anticoagulant therapy, or inability to receive anticoagulation therapy;
* New-onset stroke/transient ischemic attack within 6 months;
* Pregnant or lactating women;
* Left ventricular ejection fraction \<25%, or NYHA functional class IV, or Killip class ≥2;
* Non-target vessel revascularization within 30 days before randomization with complications.

Where it's running

• The First Affiliated Hospital of Xi'an Jiaotong University
  Xi'an, Shaanxi, China Recruiting

Study contacts

• Study coordinator: Ning Guo, Professor
• Email: hearthx@126.com
• Phone: 85323473

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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.