NCT07259239

SINGapore SoniCracker IntraVascular Lithotripsy (SING IVL) Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: National Heart Centre Singapore · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Cardiovascular Diseases

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-09-30
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2025-12-02
• Last updated: 2025-12-02

Locations

1 site across 1 country: Singapore