SoniCracker intravascular lithotripsy for calcified coronary arteries
SINGapore SoniCracker IntraVascular Lithotripsy (SING IVL) Study
This study will test whether the SoniCracker intravascular lithotripsy device can safely help open heavily calcified coronary arteries in adults having planned PCI.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | National Heart Centre Singapore Academic / other |
| Locations | 1 site (Singapore) |
| Trial ID | NCT07259239 on ClinicalTrials.gov |
What this trial studies
This is a feasibility, interventional study of the SoniCracker IVL device for patients with moderate-to-severe calcified coronary lesions undergoing elective percutaneous coronary intervention (PCI). Eligible lesions must show at least a 180° arc of calcium or nodular calcium on intravascular imaging prior to IVL therapy. The device is intended as a less aggressive, potentially lower-cost alternative to conventional atherectomy and to the commercial Shockwave IVL system. Patients requiring urgent or emergent PCI, those unable to consent, pregnant or breastfeeding women, and those with severe comorbidities are excluded.
Who should consider this trial
Good fit: Adults aged 21 or older undergoing elective/planned PCI with intravascular imaging showing at least a 180° arc of coronary calcium or nodular calcium at the target lesion are ideal candidates.
Not a fit: Patients needing urgent or emergent PCI, those unable to consent, pregnant or breastfeeding women, critically unstable patients, or those judged unsuitable by the investigator are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the device could provide a safer, less aggressive, and more cost-effective way to modify calcified plaques to improve stent delivery and reduce procedural complications.
How similar studies have performed: Similar intravascular lithotripsy devices (for example, the commercial Shockwave IVL system) have shown positive clinical results, but the SoniCracker IVL is a novel, lower-cost device with limited prior clinical data.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Singapore
- National Heart Center Singapore — Singapore, Singapore (Recruiting)
Study contacts
- Study coordinator: Yann Shan Keh
- Email: keh.yann.shan@singhealth.com.sg
- Phone: + 65 6704 8963
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.