Intravascular Imaging-Guided Intravascular Lithotripsy for Severe Coronary Calcified Lesions.
1 other identifier
observational
200
1 country
1
Brief Summary
This study aims to investigate the efficacy and safety of intravascular lithotripsy (IVL) balloon in treating coronary calcified lesions at our center.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2026
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 8, 2026
CompletedStudy Start
First participant enrolled
February 10, 2026
CompletedFirst Posted
Study publicly available on registry
March 2, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2027
ExpectedMarch 2, 2026
June 1, 2025
6 months
February 8, 2026
February 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
MACE: All-Cause Death, Recurrent Myocardial Infarction, Unplanned Target Vessel Revascularization, Acute Stent Thrombosis.
Periprocedurally and 6 months after PCI
Secondary Outcomes (1)
Residual stenosis rate after PCI.
Immediately after the PCI
Study Arms (1)
IVL group
Patients in the IVL group all received intravascular lithotripsy treatment.
Interventions
All enrolled patients underwent Intravascular Lithotripsy (IVL) and Percutaneous Coronary Intervention (PCI) under guideline-directed management.
Eligibility Criteria
Patients with coronary Artery disease and moderate to severe coronary artery calcification scheduled for PCI treatment.
You may qualify if:
- Patients with coronary angiography showing vessel diameter stenosis ≥ 70% and moderate to severe calcification;
- Reference vessel diameter ≥ 2.5 mm;
- Signed informed consent form.
You may not qualify if:
- Patients with comorbid conditions such as malignant tumors and an expected lifespan of less than 1 year;
- Patients with hemodynamic instability;
- Patients classified as New York Heart Association (NYHA) functional class IV;
- Any other conditions deemed by the investigator as unsuitable for enrollment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210000, China
Related Publications (2)
Oomens T, Vos NS, van der Schaaf RJ, Amoroso G, Ewing MM, Patterson MS, Herrman JR, Slagboom T, Vink MA. EXpansion of stents after intravascular lithoTripsy versus conventional predilatation in CALCified coronary arteries. Int J Cardiol. 2023 Sep 1;386:24-29. doi: 10.1016/j.ijcard.2023.05.012. Epub 2023 May 12.
PMID: 37178801BACKGROUNDHill JM, Kereiakes DJ, Shlofmitz RA, Klein AJ, Riley RF, Price MJ, Herrmann HC, Bachinsky W, Waksman R, Stone GW; Disrupt CAD III Investigators. Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Artery Disease. J Am Coll Cardiol. 2020 Dec 1;76(22):2635-2646. doi: 10.1016/j.jacc.2020.09.603. Epub 2020 Oct 15.
PMID: 33069849BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 8, 2026
First Posted
March 2, 2026
Study Start
February 10, 2026
Primary Completion
July 30, 2026
Study Completion (Estimated)
January 30, 2027
Last Updated
March 2, 2026
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share