Super High-pressure Balloon Versus Intravascular Lithotripsy to Prepare Severely Calcified Corona… (NCT07093788) | Clinical Trial Compass
RecruitingNot Applicable
Super High-pressure Balloon Versus Intravascular Lithotripsy to Prepare Severely Calcified Coronary Lesions
China78 participantsStarted 2025-09-01
Plain-language summary
this trial aimed to evaluate the stent expansion through intravascular imaging (optical coherence tomography (OCT) \& intravascular ultrasound (IVUS)) among individuals underwent different preparation techniques ,then comparing the efficacy and safety of super high-pressure balloon to IVL in severely calcified lesions
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
stent expansion index
Timeframe: Intraprocedural
Trial details
NCT IDNCT07093788
SponsorNanjing First Hospital, Nanjing Medical University