NCT07093788 Super High-pressure Balloon Versus Intravascular Lithotripsy to Prepare Severely Calcified Coronary Lesions
| NCT ID | NCT07093788 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nanjing First Hospital, Nanjing Medical University |
| Condition | PCI |
| Study Type | INTERVENTIONAL |
| Enrollment | 78 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 78 participants in total. It began in 2025-09-01 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Fei Ye, MD
PRINCIPAL INVESTIGATOR
The First Affiliated Hospital with Nanjing Medical University
Frequently Asked Questions
Who can join the NCT07093788 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying PCI. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07093788 currently recruiting?
Yes, NCT07093788 is actively recruiting participants. Contact the research team at doctor_ye@126.com for enrollment information.
Where is the NCT07093788 trial being conducted?
This trial is being conducted at Lianyungang, China, Nanjing, China, Yixing, China.
Who is sponsoring the NCT07093788 clinical trial?
NCT07093788 is sponsored by Nanjing First Hospital, Nanjing Medical University. The principal investigator is Fei Ye, MD at The First Affiliated Hospital with Nanjing Medical University. The trial plans to enroll 78 participants.