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ACTIVE NOT RECRUITING

NCT07340294

ClinicAL outComes of IntraVascular Lithotripsy Combined With Conventional Lesion Preparation in Patients With Moderate to Severe Coronary Artery Calcification

Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to investigate whether the clinical outcomes of combined application of intravascular lithotripsy (IVL) following routine preconditioning are superior to those of routine preconditioning alone in patients with moderate-to-severe coronary artery calcification (CAC). Its core research questions are as follows: A. To evaluate whether routine or combined application of shockwave intravascular lithotripsy can effectively reduce the target vessel failure rate in moderate-to-severe coronary artery calcification lesions. B. To evaluate the long-term prognosis of patients with coronary artery calcification. The researchers will compare the experimental group (routine preconditioning plus IVL) and the control group (routine preconditioning alone) to determine whether the combined use of intravascular lithotripsy following routine preconditioning can improve patient prognosis.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1096

Start Date

2025-10-24

Completion Date

2029-07-31

Last Updated

2026-01-14

Healthy Volunteers

Conditions

Coronary Artery Calcification Calcific Coronary Arteriosclerosis

Interventions

DEVICE

Intensive Preconditioning Group

Routine Preconditioning Strategy plus IVL (IVL may be performed before, during, or after the routine preconditioning strategy, with IVL being mandatory).The ratio of the IVL catheter size to the reference vessel diameter of the target lesion is 1:1. The IVL catheter is inflated to 4 atmospheres (atm) at the target lesion and delivers 10 pulses, followed by deflation to restore blood perfusion. A maximum of 80 pulses may be delivered, and the IVL catheter can be repositioned within the lesion. For diffuse lesions involving different reference diameters, IVL catheters of different sizes may be utilized.

DEVICE

Routine preconditioning strategy

This includes compliant balloons, non-compliant balloons, cutting/scoring balloons, excimer laser, and rotational atherectomy, to be determined at the operator's discretion

Inclusion Criteria: * Patients ≥ 18 years old * Acute or chronic coronary syndrome requiring PCI * De novo coronary lesions (excluding bypass grafts and prior stented lesions) with a target vessel reference diameter of ≥ 2.5 mm and ≤ 4.0 mm * Moderate to severe calcification, meeting one of the following criteria: • Intravascular imaging criteria: IVUS calcium score ≥ 2 points (IVUS scoring standards: a. Calcification \> 270 degrees and length \> 5 mm; b. Circumferential calcification (360 degrees); c. Calcific nodules; d. Vessel diameter \< 3.5 mm) OCT calcium score ≥ 3 points (OCT scoring standards: a. Calcification ≤ 180 degrees: 0 points; \> 180 degrees: 2 points; b. Thickness ≤ 0.5 mm: 0 points; \> 0.5 mm: 1 point; c. Length ≤ 5 mm: 0 points; \> 5 mm: 1 point) • Contrast-based classification criteria apply when intravascular imaging devices cannot pass: Coronary angiography shows clear high-density calcific shadows visible during cardiac pulsation, or clear high-density calcific shadows visible both during and without cardiac pulsation, with the length of calcific shadows on both sides of the target lesion \> 5 mm. * Willing and able to provide written informed consent Exclusion Criteria: * Patients under 18 years of age * Patients unable to provide informed consent * Pregnant or lactating female patients (pregnancy test must be performed within 7 days before surgery for women of childbearing age) * Thrombus detected by angiography or intravascular imaging * Patients with an expected life expectancy of less than 1 year * Hemodynamically unstable patients * Patients with known contraindications to heparin, anticoagulants, antiplatelet drugs, contrast agents, or other related medications * Patients with active bleeding * Patients with a new-onset stroke or transient ischemic attack (TIA) within 90 days before enrollment * Patients scheduled to undergo other cardiac interventional procedures or cardiac surgery within 30 days after PCI * Patients with ST-segment elevation myocardial infarction (STEMI) or cardiogenic shock occurring within 7 days * Severe renal insufficiency (eGFR ≤ 30 ml/min) * Left main coronary artery disease * Presence of type C-F dissection in the target vessel * Aneurysm within 10 mm of the target lesion

Locations (4)

The First Affiliated Hospital of Nanchang University (FAHNU)

Nanchang, Jiangxi, China

The People's Hospital of Liaoning Province

Shenyang, Liaoning, China

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Tianjin Fourth Central Hospital

Tianjin, China