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ShockFast Intravascular Lithotripsy Device for Treatment of Calcified Coronary Lesions
Sponsor: Shunmei Medical
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
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.
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