Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06181240
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2023-11-22
Brief Title:
Modification of Coronary Calcium With Laser Based Intravascular Lithotripsy for Coronary Artery Disease FRACTURE
Sponsor:
Bolt Medical
Organization:
Bolt Medical
Study Overview
Official Title:
Modification of Coronary Calcium With Laser Based Intravascular Lithotripsy for Coronary Artery Disease FRACTURE
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FRACTURE
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None