SINGapore SoniCracker IntraVascular Lithotripsy (SING IVL) Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Interventional cardiologists are facing an increasing burden of calcified coronary arteries in keeping with an ageing population and rising prevalence of diabetes mellitus and chronic kidney disease. Heavily calcified plaques impede balloon dilatation and successful stent delivery, resulting stent under-expansion, malposition, and damage to the drug-eluting polymer coats. This translates to poorer procedural outcomes and increased risk of Major Adverse Cardiovascular Events (MACE). The investigators' proposal seeks to determine the feasibility of the SoniCracker IVL in patients with calcified coronary lesions.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Healthy Volunteers: f
View:

• Patients at age ≥ 21 years old.

• Patients undergoing elective/ planned PCI with at least moderate coronary calcification on angiography at the target lesion are eligible for enrolment. Moderate coronary calcification is defined as densities on only one side of the arterial wall prior to contrast injection. Severe calcification was defined as radiopacities on both sides of the arterial wall prior to contrast injection.

• Patients need to demonstrate evidence of either a 180 arc of coronary calcium or nodular calcium at the target lesion on intravascular imaging prior to IVL therapy.

Locations
Other Locations
Singapore
National Heart Center Singapore
RECRUITING
Singapore
Contact Information
Primary
Yann Shan Keh
keh.yann.shan@singhealth.com.sg
+ 65 6704 8963
Backup
Si Lin Lim
lim.si.lin@nhcs.com.sg
+65 6704 2268
Time Frame
Start Date: 2025-09-30
Estimated Completion Date: 2026-07
Participants
Target number of participants: 40
Treatments
Experimental: SoniCracker IVL
Related Therapeutic Areas
Sponsors
Leads: National Heart Centre Singapore
Collaborators: Biosensor Interventional Technologies Pte Ltd

This content was sourced from clinicaltrials.gov

Similar Clinical Trials