SINGapore SoniCracker IntraVascular Lithotripsy (SING IVL) Study

NCT07259239 | Recruiting

• 1 other identifier: 2025-0308
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiovascular Diseases

Keywords

SING-IVL

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

SoniCracker IVL

EXPERIMENTAL

Device: Medical device

Interventions

Medical device 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.

SoniCracker IVL

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients at age ≥ 21 years old.
• 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.
• 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.

You may not qualify if:

• Significant co-morbidities:
• Cardiac arrest
• Cardiogenic shock
• Collapse / comatose / semi-conscious states
• Patients requiring urgent or emergent PCI.
• Patients who are unable to provide consent.
• Patients who are pregnant.
• Breast-feeding women
• 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).

Sponsors & Collaborators

• National Heart Centre Singapore: lead
• Biosensor Interventional Technologies Pte Ltd: collaborator

Study Sites (1)

National Heart Center Singapore

Singapore, 169609, Singapore

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Equipment and Supplies

Central Study Contacts

Yann Shan Keh

CONTACT

+ 65 6704 8963; keh.yann.shan@singhealth.com.sg

Si Lin Lim

CONTACT

+65 6704 2268; lim.si.lin@nhcs.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: At baseline, enrolled participants will be treated with the study device - SoniCracker Intravascular Lithotripsy Balloon during routine percutaneous coronary intervention (PCI). This device consists of a single-use, sterile catheter with multiple emitters mounted on a coronary balloon. The balloon is inserted into the coronary arteries. The emitters on the balloon then create shockwaves that cause cracks the calcium of the coronary arteries. The catheter is removed after the procedure. The rest of the PCI will be performed as per regular care. At 30 days post PCI procedure, participants will be followed up via telephone calls.

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: December 2, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-06

Locations

SG (1)