SoniCracker intravascular lithotripsy for calcified coronary arteries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.