🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT07093788
Recruiting Not applicable

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

NCT07093788 · tracked via the Priya Life Science China tracker
Sponsor
Nanjing First Hospital, Nanjing Medical University
Phase
Not applicable
Started
2025-09-01
Last updated
2026-03-10

Condition(s) studied

PCICoronary Arterial Disease (CAD)Calcified Coronary Lesions

Investigational drug(s) / intervention(s)

super high-pressure balloonintravascular lithotripsy (IVL)

super high-pressure balloon: preparation strategy for calcified lesions after unsatisfactory dilation

intravascular lithotripsy (IVL): preparation strategy for calcified lesions after unsatisfactory dilation

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
Lianyungang First People's Hospital Lianyungang Jiangsu Recruiting
Nanjing First Hospital Nanjing Jiangsu Recruiting
Yixing People's Hospital Yixing Jiangsu Recruiting

More Nanjing First Hospital, Nanjing Medical University trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07093788 on ClinicalTrials.gov ↗ ← All trials in China