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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Coronary Artery Calcification Coronary Microcirculation Dysfunction Intravascular Lithotripsy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Second Affiliated Hospital of Zhejiang University School of Medicine 88 Jiefang Road

Hangzhou, Zhejiang, 310009, China

About this study

This retrospective, multicenter, observational study.The study protocol was approved by the institutional review board at participating centers and was conducted in accordance with the principles of the Declaration of Helsinki. Owing to the retrospective nature of the study, the requirement for written informed consent was waived.Consecutive patients who underwent RA or IVL due to serve calcification during the PCI at the three participating centers between January 1, 2018, and October 31, 2024, were included in this retrospective analysis. 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.The follow-up entailed the utilization of a multipronged approach, encompassing clinic visits, medical record reviews and telephone contacts.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

MACE

Time frame: 1 year

composite of cardiac death, myocardial infarction, target vessel revascularization, or readmission for unstable angina

Secondary outcomes

target vessel failure

Time frame: 1 year

composite of cardiac death, myocardial infarction, or target-vessel revascularization

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

A Study Comparing the Effects of Coronary Rotational Atherectomy and Intravascular Lithotripsy on Coronary Microcirculation in Patients With Severe Calcified Lesions

Important dates

Study start: 2018
Primary completion: 2024
Study completion: 2026
First posted: Jul 13, 2026
Registry last updated: Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed