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

NCT07699965 | Active Not Recruiting

• 1 other identifier: 20251689
• Study Type: observational
• Target: 590
• Locations: 1 country
• Sites: 1

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

Conditions

Coronary Artery Calcification; Intravascular Lithotripsy; Coronary Microcirculation Dysfunction

Keywords

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

Outcome Measures

Primary Outcomes (1)

• MACE

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

  1 year

Secondary Outcomes (1)

• target vessel failure

  1 year

Study Arms (2)

Intravascular lithotripsy group

Angio-IMR\>=25 OR Angio-IMR\<25

Rotational atherectomy

Angio-IMR\>=25 OR Angio-IMR \<25

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients who underwent RA or IVL due to serve calcification during the PCI between January 1, 2018, and October 31, 2024.

You may qualify if:

• 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-

You may not qualify if:

• encompassed the presence of severe calcification treated with RA and IVL, in-stent restenosis and suboptimal angiographic image quality

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

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

Hangzhou, Zhejiang, 310009, China

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 13, 2026
• Study Start: January 1, 2018
• Primary Completion: December 31, 2024
• Study Completion (Estimated): September 30, 2026
• Last Updated: July 13, 2026

Record last verified: 2026-06

Locations

CN (1)