RecruitingNot ApplicableNCT07093788

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

Super High-pressure Balloon Versus Intravascular Lithotripsy to Prepare Severely Calcified Coronary Lesions: a Randomized Controlled Trial (Shape)


Sponsor

Nanjing First Hospital, Nanjing Medical University

Enrollment

78 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called intravascular lithotripsy (IVL) and a medical device called super high-pressure balloon for people with calcified coronary lesions, coronary arterial disease (cad), and other related conditions. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 18 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEsuper high-pressure balloon

preparation strategy for calcified lesions after unsatisfactory dilation

DEVICEintravascular lithotripsy (IVL)

preparation strategy for calcified lesions after unsatisfactory dilation


Locations(3)

Lianyungang First People's Hospital

Lianyungang, Jiangsu, China

Nanjing First Hospital

Nanjing, Jiangsu, China

Yixing People's Hospital

Yixing, Jiangsu, China

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NCT07093788


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