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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07699965

Enrollment

590

Registered

2026-07-13

Start date

2018-01-01

Completion date

2026-09-30

Last updated

2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Calcification, Coronary Microcirculation Dysfunction, Intravascular Lithotripsy

Keywords

Intravascular lithotripsy, Rotational atherectomy, Coronary microcirculation dysfunction, Coronary artery calcification, Index of microcirculatory resistance

Brief 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

Detailed description

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
MACE	1 year	composite of cardiac death, myocardial infarction, target vessel revascularization, or readmission for unstable angina

Secondary

Measure	Time frame	Description
target vessel failure	1 year	composite of cardiac death, myocardial infarction, or target-vessel revascularization

Countries

China

Outcome results