NCT07407738

ShockFast Intravascular Lithotripsy Device for Treatment of Calcified Coronary Lesions

ShockFast Intravascular Lithotripsy Device for Treatment of Calcified Coronary Lesions, a Prospective, Randomised, International Trial: ShockFast IVL Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Shunmei Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Coronary artery disease is caused by narrowing of the artery lumen. Treatment with Percutaneous Coronary Intervention (PCI) may be needed. This is a minimally invasive procedure used to treat narrowed or blocked coronary arteries. Sometimes a stent is placed to keep the artery open. If the lesions in the coronary artery are calcified, this may cause difficulties for successful stent placement. The calcified plaques can be fractured via intravascular lithotripsy (IVL) with devices like ShockWave IVL and ShockFast IVL. The aim of this study is to compare the this relatively new ShockFast IVl with the more widely used ShockWave IVL.

Detailed description

Coronary calcified lesions have evolved as one of the most challenging indications for coronary percutaneous interventions (PCI). Different dedicated devices have been recently introduced into the market to improve procedural success in this challenging PCI population. Shockwave Intravascular Lithotripsy, (Shockwave IVL), Shockwave Medical, SC, CA, USA, was the first intracoronary device that used sonic pressure to fracture intracoronary calcium. The device safety and efficacy has been proved in a series of clinical trials. ShockFast intravascular lithotripsy (ShockFast IVL), Shunmei medical, Shenzhen, China, is a new dedicated device to treat intracoronary calcium that makes use of sonic pressure waves to fracture calcified plaques. ShockFast IVL has recently obtained CE mark approval for this indication. The aim of this study is to compare this new lithotripsy device (ShockFast IVL) with the existing and widely used lithotripsy device that uses the same principle of action, the Shockwave IVL, Shockwave Medical, SC, CA, USA.

Conditions

• Coronary Arterial Disease
• Calcified Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Shockwave IVL	Treatment of subjects with coronary calcified lesions with an interventional procedure that utilizes a fluid-filled catheter connected to an energy source that generates mechanistically tuned ultrasonic acoustic pressure waves - or Shockwaves - for modification, fracture, and fragmentation of vascular calcification.
DEVICE	Shockfast IVL	Treatment of subjects with coronary calcified lesions with an interventional procedure using a dedicated device to treat coronary calcified lesions by offering precise control of sonic pressure waves for safe fracture calcium deposits within the artery walls, thus maintaining vessel flexibility and promoting smoother stent placement. The ShockFast device has an improved crossing profile and 2 lengths of the catheter: 12 and also 15mm compared to ShockWave which has only 1 length.

Timeline

• Start date: 2026-02-28
• Primary completion: 2026-08-01
• Completion: 2026-11-01
• First posted: 2026-02-12
• Last updated: 2026-02-12

Locations

11 sites across 3 countries: France, Poland, Spain