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)
stent expansion index — Intraprocedural The stent expansion was associated with post-PCI clinical outcomes and the risk of stent failure.In this study, the primary endpoint was stent expansion index, which was defined as the final minimal luminal area (MLA) within the treated segment divided by the average reference vessel area assessed with intravascular imaging (optical coherence tomography(OCT)\&intravascular ultrasound(IVUS)).
Trial sites (3)
Facility
City
Region
Status
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
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.
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