SINGapore SoniCracker IntraVascular Lithotripsy (SING IVL) Study
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, malp
| Condition(s) | Cardiovascular Diseases |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: 1. Patients at age ≥ 21 years old. 2. 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. 3. 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. Exclusion Criteria: 1. Significant co-morbidities: * Cardiac arrest * Cardiogenic shock * Collapse / comatose / semi-conscious states 2. Patients requiring urgent or emergent PCI. 3. Pa |
| Ages | 21 Years |
| Sex | All |
| Lead sponsor | National Heart Centre Singapore |
| Locations | Singapore, Singapore |
| Start date | 2025-09-30 |
| NCT ID | NCT07259239 |
| Official listing | https://clinicaltrials.gov/study/NCT07259239 |