Super High-pressure Balloon Versus Intravascular Lithotripsy to Prepare Severely Calcified Coronary Lesions (Shape)

Nanjing Medical University

Status: Enrolling

Conditions: Coronary Arterial Disease (CAD); PCI; Calcified Coronary Lesions

Treatments: Device: super high-pressure balloon; Device: intravascular lithotripsy (IVL)

Study type: Interventional

Funder types: Other

Identifiers

NCT07093788

KY20250425-03

Details and patient eligibility

About

this trial aimed to evaluate the stent expansion through optical coherence tomography (OCT) among individuals underwent different preparation techniques ,then comparing the efficacy and safety of super high-pressure balloon to IVL in severely calcified lesions

Full description

Calcified lesions posed a significant challenge in percutaneous coronary intervention (PCI). The existence of calcified plaque increased the difficulty of optimal stent expansion and the risk of target lesion failure(TLF). Consequently, optimizing the preparation techniques for calcified lesions before stent implantation has assumed growing importance.

As a kind of novel double-layered balloon, super high-pressure balloon can expand uniformly under extreme pressure. Previous studies have demonstrated that super high-pressure balloon perform non-inferiorly or superiorly to other strategies in terms of final stent expansion.

Through triggering localized pulsatile sonic pressure, intravascular lithotripsy(IVL) cracked intimal and medial calcium plaque within the artery. In present series of studies(DISRUPT), the optimized preparation of calcified lesions with IVL has been proved to be safe and effective. According to guidelines and clinical practice, IVL is applicable to different types of severe calcification lesions, including concentric and eccentric calcifications. However, considering its technological and economic costs, finding other preparation techniques non-inferiority to IVL was essential. In clinical practice, super high-pressure balloon had shown considerable effects of preparation for calcified lesions. However, study focused on the comparison of super high-pressure balloon with IVL for severe calcified lesions was limited.

In summary, this randomized trial aimed to evaluate the stent expansion through optical coherence tomography (OCT) among individuals underwent different preparation techniques ,then comparing the efficacy and safety of super high-pressure balloon to IVL in severely calcified lesions

Enrollment: 78 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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78 participants in 2 patient groups

Super high-pressure balloon

Experimental group

Description:

Patients underwent OCT-guided PCI were treated with super high-pressure balloon for lesion preparation.

Treatment:

Device: super high-pressure balloon

Intravascular lithotripsy (IVL)

Experimental group

Description:

Patients underwent OCT-guided PCI were treated with Intravascular lithotripsy (IVL) for lesion preparation.

Treatment:

Device: intravascular lithotripsy (IVL)