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

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.

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

Sponsors & Collaborators

• First Hospital of China Medical University

  collaborator OTHER

• The First Affiliated Hospital of Nanchang University

  collaborator OTHER

• The People's Hospital of Liaoning Province

  collaborator OTHER

• Tianjin Forth Central Hospital

  collaborator UNKNOWN

• Second Affiliated Hospital, School of Medicine, Zhejiang University

  lead OTHER

Principal Investigators

• Bingchen Liu, Phd,MD · 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

• Bingchen Liu, Phd,MD · 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-10-24

Primary Completion

2027-11-30

Completion

2029-07-31

Countries

• China

Study Locations