NCT06181240

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 426 (actual)
• Sponsor: Bolt Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

The FRACTURE Trial is a prospective, non-randomized, single-arm, multicenter, interventional study in US and international centers with the Bolt Intravascular Lithotripsy System that was designed to percutaneous transluminal angioplasty by utilizing delivery of IVL to disrupt calcium prior to full balloon dilatation at low pressures.

Conditions

• Coronary Artery Disease
• Coronary Artery Calcification

Interventions

Type	Name	Description
DEVICE	Intravascular lithotripsy	Lithotripsy-enhanced percutaneous coronary intervention of de novo, calcified, stenotic coronary artery lesions prior to stenting.

Timeline

• Start date: 2024-01-19
• Primary completion: 2026-02-05
• Completion: 2028-03-20
• First posted: 2023-12-26
• Last updated: 2026-04-08

Locations

46 sites across 7 countries: United States, Belgium, Denmark, Germany, Lithuania, Netherlands, United Kingdom

Regulatory

• FDA-regulated device study