Actively Recruiting
SINGapore SoniCracker IntraVascular Lithotripsy (SING IVL) Study
Led by National Heart Centre Singapore · Updated on 2025-12-02
40
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
Sponsors
N
National Heart Centre Singapore
Lead Sponsor
B
Biosensor Interventional Technologies Pte Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
SINGapore SoniCracker IntraVascular Lithotripsy (SING IVL) Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 21 years or older
- Undergoing elective or planned PCI with at least moderate coronary calcification on angiography at the target lesion
- Evidence of either a 180 degree arc of coronary calcium or nodular calcium at the target lesion on intravascular imaging prior to IVL therapy
You will not qualify if you...
- History of cardiac arrest, cardiogenic shock, collapse, coma, or semi-conscious state
- Need for urgent or emergent PCI
- Unable to provide consent
- Pregnant women
- Breastfeeding women
- Any condition deemed unsuitable by the Investigator, including other medical reasons, laboratory abnormalities, expected noncompliance, or unwillingness to follow study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Heart Center Singapore
Singapore, Singapore, 169609
Actively Recruiting
Research Team
Y
Yann Shan Keh
CONTACT
S
Si Lin Lim
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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