Comparing two shockwave devices for calcified coronary artery disease
Compares ShockFast and ShockWave devices for calcium-hardened heart arteries in adults.
Plain-language title generated from the registry record
Registry title: ShockFast Intravascular Lithotripsy Device for Treatment of Calcified Coronary Lesions
Key facts
- Where
- Bad Segeberg and Lahr, GermanySee the 2 sites
Where in Germany
- Segeberger Kliniken GMBH / Herz- und GefäßzentrumBad Segeberg, GermanyTaking people
- MediClin Heart Center LahrLahr, GermanyNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shunmei Medical
- Trial code
- NCT07407738
- Record updated
- 29 September 2026
- Original 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.Read full original descriptionShow less
ShockFast Intravascular Lithotripsy Device for Treatment of Calcified Coronary Lesions, a Prospective, Randomised, International Trial: ShockFast IVL Trial
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.
Inclusion: 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.
Exclusion: Inability to tolerate dual antiplatelet therapy for 6 months or longer; Ejection fraction less than 25%; Severe renal Impairment; Serum Creatinine > 220 μmol or currently undergoing hemodialysis; Lesion located in Left Main (LM) coronary artery; Calcifications located mostly > 0.5 mm from the vessel lumen; Severe lesion tortuosity where OCT is judged impossible to cross; Inability to obtain inform consent or deemed poorly compliant by the investigator; Presence of permanent pacemaker; Angiographic evidence of thrombus in the target vessel; Target lesion located at or involving within 5mm of the coronary ostium of the Left Anterior Descending artery (LAD), Left Circumflex artery (LCX); Target lesion is a chronic total occlusion (CTO); Presence of aneurysm within 10mm proximal or distal to the target lesion.