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Modification of Coronary Calcium With Laser Based Intravascular Lithotripsy for Coronary Artery Disease (FRACTURE)

NCT06181240 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 426

Last updated 2026-05-06

No results posted yet for this study

Summary

The FRACTURE Trial is a prospective, non-randomized, single-arm, multicenter, interventional study in US and international centers.

Conditions

Interventions

DEVICE

Intravascular lithotripsy

Lithotripsy-enhanced percutaneous coronary intervention of de novo, calcified, stenotic coronary artery lesions prior to stenting.

Sponsors & Collaborators

  • Bolt Medical

    lead INDUSTRY

Principal Investigators

  • Margaret McEntegart, MD, PhD · NY Presbyterian Hospital/Columbia University Medical Center

  • Nicholas van Mieghem, MD, PhD · Erasmus Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-19
Primary Completion
2026-02-05
Completion
2028-03-20
FDA Device
Yes

Countries

  • United States
  • Belgium
  • Denmark
  • Germany
  • Lithuania
  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06181240 on ClinicalTrials.gov