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NOT YET RECRUITING
NCT07407738
NA

ShockFast Intravascular Lithotripsy Device for Treatment of Calcified Coronary Lesions

Sponsor: Shunmei Medical

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2026-02-28

Completion Date

2026-11-01

Last Updated

2026-02-12

Healthy Volunteers

No

Interventions

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.

Locations (11)

Infirmerie Protestante de Lyon

Lyon, France

Centre Cardiologique du Nord

Paris, France

Centre Hospitalier de Valenciennes

Valenciennes, France

Medical University of Silesia

Katowice, Poland

University Hospital Krakow

Krakow, Poland

Miedziowe Centrum Zdrowia

Lubin, Poland

Regional Specialist Hospital

Wroclaw, Poland

La Paz University Hospital

Madrid, Spain

La Princesa Univeristy Hospital

Madrid, Spain

Virgen Arrixaca University Clinical Hospital

Murcia, Spain

Virgen del Rocío University Hospital

Seville, Spain