SINGapore SoniCracker IntraVascular Lithotripsy (SING IVL) Study

Singapore Health Services (SingHealth)

Status: Enrolling

Conditions: Cardiovascular Diseases

Treatments: Device: Medical device

Study type: Interventional

Funder types: Other

Identifiers

NCT07259239

2025-0308

Details and patient eligibility

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.

Full description

Coronary calcifications are one of the strongest predictors of adverse intraprocedural and long-term PCI outcomes. We believe SoniCraker IVL provides a safer and less aggressive method of calcium modification as opposed to traditional coronary atherectomy, hence translating into better clinical outcomes for patient. Although there is a commercially available IVL (Shockwave balloon) available, it is currently priced at ~ SGD 4000. The SoniCracker IVL is potentially a more cost-effective alternative to the Shockwave IVL.

Enrollment: 40 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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. Patients who are unable to provide consent.

4. Patients who are pregnant.

5. Breast-feeding women

6. Any patients whom the Investigator deems unsuitable for the study (e.g., due to other medical reasons, laboratory abnormalities, expected study medication noncompliance, or subject's unwillingness to comply with all study-related study procedures).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

SoniCracker IVL

Experimental group

Treatment:

Device: Medical device