ShockFast Intravascular Lithotripsy Device for Treatment of Calcified Coronary Lesions

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShunmei Medical

About this 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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Ejection fraction less than 25%

Lesion located in Left Main (LM) coronary artery

Calcifications located mostly > 0.5 mm from the vessel lumen.

Severe renal Impairment; Serum Creatinine > 220 μmol or currently undergoing hemodialysis

Trial design

Treatments tested in this trial

  • Shockwave IVL
  • Shockfast IVL

Treatment groups

120 Participants
are divided into 2 treatment groups

Sponsors and collaborators