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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Shockwave IVL
DeviceTreatment 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
DeviceTreatment 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.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Shockfast IVLExperimental treatment 1 intervention
Group B: Shockwave IVLActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Stent area post PCI measured at the minimal lumen area during initial procedure, evaluated by OCT
Time frame
Hospitalisation (during procedure)Secondary outcomes
1
Target lesion failure defined as cardiac death, target-vessel myocardial infarction and target-lesion revascularisation at discharge and 30 days
Time frame
30 day follow-up2
Angiographic success
* Defined as a successful stent delivery with diameter of stenosis post PCI of \<50% without severe dissection (type D-F), perforation, abrupt vessel closure or persistent less than Thrombolysis in Myocardial Infarction (TIMI)-3 flow. * By collecting data through angiography and imaging: * Minimal lumen area post stenting * Residual area of stenosis * Residual diameter of stenosis \<30% * Residual diameter of stenosis \<50% * Optical Coherence Tomography (OCT) measured under expansion (\<80% of the reference lumen area) * Post-IVL acute area gain (measured at the minimum lumen area post IVL) * Number of visible calcium cracks post IVL * Severe coronary dissection post IVL (type C-F)
Time frame
Hospitalisation (during procedure)3
Device success
Defined as success of the device to cross and fully expand
Time frame
Hospitalisation (during procedure)Sponsors and contacts
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Source ClinicalTrials.gov