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

NCT07699965 · tracked via the Priya Life Science China tracker

Sponsor

Second Affiliated Hospital, Zhejiang University, School of Medicine

Phase

Observational

Started

2018-01-01

Last updated

2026-07-13

Condition(s) studied

Coronary Artery CalcificationIntravascular LithotripsyCoronary Microcirculation Dysfunction

Study 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

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: Consecutive patients who underwent RA or IVL due to serve calcification during the PCI. Severe calcification was defined angiographically as radiopacities visible on both sides of the vessel lumen before contrast injection, or by intravascular ultrasound (IVUS) as a circumferential arc of calcification ≥270° extending for ≥5 mm in length- Exclusion Criteria: encompassed the presence of severe calcification treated with RA and IVL, in-stent restenosis and suboptimal angiographic image quality

Primary outcome measure(s)

MACE — 1 year
composite of cardiac death, myocardial infarction, target vessel revascularization, or readmission for unstable angina

Trial sites (1)

Facility	City	Region	Status
The Second Affiliated Hospital of Zhejiang University School of Medicine 88 Jiefang Road	Hangzhou	Zhejiang

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Official registry record

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.

View NCT07699965 on ClinicalTrials.gov ↗ ← All trials in China