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, 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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Device: Medical device

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yann Shan Keh; Phone Number: + 65 6704 8963; Email: keh.yann.shan@singhealth.com.sg
• Study Contact Backup: Name: Si Lin Lim; Phone Number: +65 6704 2268; Email: lim.si.lin@nhcs.com.sg

Study Locations

• Singapore
  • Singapore, Singapore, 169609
    • Recruiting
    • National Heart Center Singapore
    • Contact: Yann Shan Keh; Phone Number: 93892179; Email: keh.yann.shan@singhealth.com.sg
    • Principal Investigator: Yann Shan Keh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: SoniCracker IVL

Device: Medical device; The SoniCracker IVL is a rapid-exchange catheter with an effective length of 1420mm, with two radiopaque markers at the distal end and is coated with a hydrophilic coating from the distal tip to the wire exchange port to facilitate tracking and catheter delivery during use. The catheter lumen consists of a wire lumen, an inflation lumen, and two shockwave electrodes. The wire lumen allows passage of a 0.014" guidewire to guide the catheter into and through the lesion. The inflation lumen is filled with a 50%/50% mixture of physiological saline and contrast media to inflate and deflate the balloon. The electrode traverses the entire effective length of the catheter for lithotripsy treatment. The proximal end of the catheter features a hub with two ports, one for inflation/deflation of the balloon, and the other for connecting the electrode wires to the Coronary intravascular lithotripsy therapy device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural success	Successful delivery and deployment of the study device, and attainment of less than 50% diameter stenosis after stenting with no evidence of in-hospital major adverse cardiac events (MACE: cardiac death, myocardial infarction or target vessel revascularization)	Perioperative

Secondary Outcome Measures

Outcome Measure	Time Frame
Device success (successful delivery and deployment of a device, and attainment of less than 50% diameter stenosis), 30-day MACE, coronary complications, post procedural angiographic and intravascular imaging outcomes	Up to 30 days (+ 1 month) post PCI

Collaborators and Investigators

• Sponsor: National Heart Centre Singapore
• Collaborators: Biosensor Interventional Technologies Pte Ltd

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: October 1, 2025
• First Submitted That Met QC Criteria: November 26, 2025
• First Posted (Actual): December 2, 2025

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: SING-IVL
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Equipment and Supplies
• Other Study ID Numbers: 2025-0308

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No