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

NCT07340294 | Active Not Recruiting

• 1 other identifier: 2025-0812
• Study Type: interventional
• Target: 1,096
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

atherosclerosi; calcification; coronary artery calcification

Outcome Measures

Primary Outcomes (1)

• target vessel failure rate

  24-month target vessel failure (TVF) rate (a composite endpoint of cardiovascular death, target vessel myocardial infarction \[TVMI\], and clinically indicated target vessel revascularization \[TVR\])

  1month; 12 months; 24 months

Secondary Outcomes (1)

• MACE

  1 month; 12 months; 24 months

Study Arms (2)

Intensive Preconditioning Group

EXPERIMENTAL

Routine preconditioning strategy + IVL 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: Intensive Preconditioning Group

Control group

OTHER

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.

Device: Routine preconditioning strategy

Interventions

Intensive Preconditioning Group DEVICE

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.

Intensive Preconditioning Group

Routine preconditioning strategy DEVICE

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

Control group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital of Nanchang University: collaborator
• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• First Hospital of China Medical University: collaborator
• The People's Hospital of Liaoning Province: collaborator
• Tianjin Forth Central Hospital: collaborator

Study Sites (4)

The First Affiliated Hospital of Nanchang University (FAHNU)

Nanchang, Jiangxi, China

Location

The People's Hospital of Liaoning Province

Shenyang, Liaoning, China

Location

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Location

Tianjin Fourth Central Hospital

Tianjin, China

Location

MeSH Terms

Conditions

Calcinosis

Condition Hierarchy (Ancestors)

Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Bingchen Liu, Phd,MD

  2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

  STUDY CHAIR

• Bingchen Liu, Phd,MD

  2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: January 14, 2026
• Study Start: October 24, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): July 31, 2029
• Last Updated: January 14, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

CN (4)