Clinical Trial

Prognostic Impact of Coronary Microvascular Dysfunction After IVL Versus RA in Patients With Severe Coronary Calcification Undergoing PCI

Active, Not Recruiting
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Summary
The goal of this observational study is to lean that whether the distinct mechanisms by which intravascular lithotripsy (IVL) and rotational atherectomy (RA) treat severe coronary calcification differentially affect the microcirculation, leading to coronary microvascular dysfunction (CMD). The main question it aims to answer is: we evaluated the prognostic value of post-percutaneous coronary intervention (PCI) CMD, assessed by the angiography-derived index of microcirculatory resistance (angio-IMR), in patients with severe coronary calcification undergoing RA or IVL. Participants will answer survey questions about their clinical outcomes for 1 year by telephone
Protocol Amendment History 1 change
notable Sponsor changed: Second Affiliated Hospital, School of Medicine, Zhejiang University -> Second Affiliated Hospital, Zhejiang University, School of Medicine 2026-08-09
Trial Details
NCT Number NCT07699965
Lead Sponsor Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions Coronary Artery Calcification, Intravascular Lithotripsy, Coronary Microcirculation Dysfunction
Enrollment 590 participants
Start Date 2018-01-01
Primary Completion 2024-12-31 (estimated)
Study Completion 2026-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-13