ShockFast Intravascular Lithotripsy Device for Treatment of Calcified Coronary Lesions (NCT07407738) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
ShockFast Intravascular Lithotripsy Device for Treatment of Calcified Coronary Lesions
France, Poland120 participantsStarted 2026-02-28
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
✓. 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)
Exclusion criteria
✕. Ejection fraction less than 25%
✕. Lesion located in Left Main (LM) coronary artery
What they're measuring
1
Stent area post PCI measured at the minimal lumen area during initial procedure, evaluated by OCT