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ShockFast Intravascular Lithotripsy Device for Treatment of Calcified Coronary Lesions

Sponsor: Shunmei Medical • ClinicalTrials.gov ID: NCT07407738

Registry updated: 2026-09-29

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Description

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.

Interventions

Shockwave IVL (Device)
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 (Device)
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.

Eligibility criteria

Inclusion Criteria: 1. 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: 2. Native de novo coronary lesions 3. Vessel diameter between 2.5mm - 4.0mm 4. Lesion Length: ≤40mm 5. Severe Calcification: 1. 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 2. Presence of severe calcified protruding noduli 6. No flow disturbances at baseline (Thrombolysis in Myocardial Infarction \[TIMI\] 3 flow at baseline) 7. Target lesion with diameter stenosis ≥70% by visual, or ≥50% with evidence of clinical ischemia OCT Criteria: 8. Total calcium arc \> 180° or 9. Presence of a protruding calcified noduli Exclusion Criteria: 1. Ejection fraction less than 25% 2. Lesion located in Left Main (LM) coronary artery 3. Calcifications located mostly \> 0.5 mm from the vessel lumen. 4. Severe renal Impairment; Serum Creatinine \> 220 μmol or currently undergoing hemodialysis 5. Severe lesion tortuosity where OCT is judged impossible to cross. 6. Inability to tolerate dual antiplatelet therapy for 6 months or longer 7. Inability to obtain inform consent or deemed poorly compliant by the investigator 8. Presence of permanent pacemaker 9. Angiographic evidence of thrombus in the target vessel 10. Target lesion located at or involving within 5mm of the coronary ostium of the Left Anterior Descending artery (LAD), Left Circumflex artery (LCX) 11. Target lesion is a chronic total occlusion (CTO) 12. Presence of aneurysm within 10mm proximal or distal to the target lesion

Conditions

Coronary Arterial Disease Calcified Coronary Artery Disease

Locations

Infirmerie Protestante de Lyon — Lyon, France
Centre Cardiologique du Nord — Paris, France
Centre Hospitalier de Valenciennes — Valenciennes, France
Segeberger Kliniken GMBH / Herz- und Gefäßzentrum — Bad Segeberg, Germany
MediClin Heart Center Lahr — Lahr, Germany
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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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