ShockFast Intravascular Lithotripsy Device for Treatment of Calcified Coronary Lesions, a Prospective, Randomised, International Trial: ShockFast IVL Trial
Status: Recruiting
Location: See all (13) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Patients aged ≥18 years undergoing PCI for stable or unstable angina or staged procedure after successful treatment of a myocardial infarction where heart enzymes are decreasing
• Angiographic criteria:
• Native de novo coronary lesions
• Vessel diameter between 2.5mm - 4.0mm
• Lesion Length: ≤40mm
• Severe Calcification:
‣ Calcification visible on the upper and the lower sides of the vessel wall in at least two angiographic projections that differ ≥ 60° from each other
⁃ Presence of severe calcified protruding noduli
• No flow disturbances at baseline (Thrombolysis in Myocardial Infarction \[TIMI\] 3 flow at baseline)
• Target lesion with diameter stenosis ≥70% by visual, or ≥50% with evidence of clinical ischemia
• OCT Criteria:
• Total calcium arc \> 180° or
• Presence of a protruding calcified noduli
Locations
Other Locations
France
Infirmerie Protestante de Lyon
RECRUITING
Lyon
Centre Cardiologique du Nord
RECRUITING
Paris
Centre Hospitalier de Valenciennes
NOT_YET_RECRUITING
Valenciennes
Germany
Segeberger Kliniken GMBH / Herz- und Gefäßzentrum
NOT_YET_RECRUITING
Bad Segeberg
MediClin Heart Center Lahr
NOT_YET_RECRUITING
Lahr
Poland
Medical University of Silesia
NOT_YET_RECRUITING
Katowice
University Hospital Krakow
NOT_YET_RECRUITING
Krakow
Miedziowe Centrum Zdrowia
RECRUITING
Lubin
Regional Specialist Hospital
RECRUITING
Wroclaw
Spain
La Paz University Hospital
RECRUITING
Madrid
La Princesa Univeristy Hospital
ACTIVE_NOT_RECRUITING
Madrid
Virgen Arrixaca University Clinical Hospital
RECRUITING
Murcia
Virgen del Rocío University Hospital
RECRUITING
Seville
Contact Information
Primary
Jasper Yang
cm@shunmed.com
008615363476127
Time Frame
Start Date:2026-02-16
Estimated Completion Date:2027-03-01
Participants
Target number of participants:120
Treatments
Experimental: Shockfast IVL
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.
Active_comparator: Shockwave IVL
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.