Bolt FRACTURE IDE trial
Research type
Research Study
Full title
ModiFication of coRonAr), Calcium with Iaser based inTravascUlaR lithotripsy for coronary artEry disease (FRACTURE}
IRAS ID
328394
Contact name
James Spratt
Contact email
Sponsor organisation
Bolt Medical, Inc
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 16 days
Research summary
Coronary artery disease (CAD) is caused by thickening or hardening of the arteries caused by a buildup of plaque (calcium deposits) in the inner lining of an artery which results in arterial narrowing and restricted blood flow to the heart. This can lead to symptoms of angina and decreased heart function.
There are currently various treatment options, however, when there is a lot of plaque buildup on the artery it becomes more difficult to open the artery without risk of rupture of the artery wall or poor results. Opening the artery with a balloon (PTA) is a often used procedure. The use of shockwaves to pretreat the plaque can offer advantages to open the artery and lower the risks involved. Notably, the use of shockwaves targets both superficial and deep calcium deposits.
Bolt medical has developed the Bolt Intravascular Lithotripsy System (IVL) which is a device consisting of a balloon catheter (for PTA) and a console designed to generate a shockwave through the catheter to disrupt calcium prior to full balloon dilatation at low pressures.
The IVL is not yet market release and this study is to obtain patient data to demonstrate the safety and effectiveness of the Bolt IVL System.
A total of approximately 432 subjects will be enrolled at up to 40 sites globally. In the study patients undergo screening, baseline evaluation, the study procedure and clinical follow-up visits at up to 2 years.REC name
South East Scotland REC 02
REC reference
23/SS/0108
Date of REC Opinion
14 Dec 2023
REC opinion
Further Information Favourable Opinion