NCT07340294Active, not recruiting
ClinicAL outComes of IntraVascular Lithotripsy Combined With Conventional Lesion Preparation in Patients With Moderate to Severe Coronary Artery Calcification
Source: ClinicalTrials.gov · Last updated 14 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 1096 (actual)
- First submitted
- 6 Jan 2026
- Start date
- 24 Oct 2025
- Primary completion date
- 30 Nov 2027
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Diseases
- Coronary artery disease
- NCT number
- NCT07340294
What you commit to
- Study type: Interventional
- Participants enrolled: 1096
- From 24 Oct 2025 to the primary completion date, 30 Nov 2027
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Pregnant or lactating female patients (pregnancy test must be performed within 7 days before surgery for women of childbearing age)
- Patients with known contraindications to heparin, anticoagulants, antiplatelet drugs, contrast agents, or other related medications
- Patients with a new-onset stroke or transient ischemic attack (TIA) within 90 days before enrollment
Other illness
- Patients with active bleeding
- 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
- Left main coronary artery disease
Lab values
- Severe renal insufficiency (eGFR ≤ 30 ml/min)
Age
- Patients under 18 years of age
Other
- Patients unable to provide informed consent
- Thrombus detected by angiography or intravascular imaging
- Patients with an expected life expectancy of less than 1 year
- Hemodynamically unstable patients
- Presence of type C-F dissection in the target vessel
- Aneurysm within 10 mm of the target lesion
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Second Affiliated Hospital, School of Medicine, Zhejiang University Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| The First Affiliated Hospital of Nanchang University (FAHNU) Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| The People's Hospital of Liaoning Province Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
| Tianjin Fourth Central Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.