Clinical Trial

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

Study acronym: Shape
Recruiting
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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
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-07-22; most recent amendment 2026-03-06.
Trial Details
NCT Number NCT07093788
Lead Sponsor Nanjing First Hospital, Nanjing Medical University
Conditions PCI, Coronary Arterial Disease (CAD), Calcified Coronary Lesions
Enrollment 78 participants
Start Date 2025-09-01
Primary Completion 2026-12-30 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-03-10