ShockFast IVL vs ShockWave IVL for Calcified Coronary Lesions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study compares two intravascular lithotripsy devices, ShockFast IVL and ShockWave IVL, in adults with calcified coronary lesions undergoing PCI. Eligible participants have de novo native coronary lesions with severe calcification and specific vessel and lesion criteria. Procedures involve using either device to fracture calcium to facilitate stent placement, with outcomes focused on procedural success and safety. The study is conducted at multiple European centers and is led by Shunmei Medical as the sponsor. CE-marked ShockFast IVL is being evaluated against the more established ShockWave IVL in real-world PCI settings.

Why it matters

Who can join: the full rules

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

Where it's running

• Infirmerie Protestante de Lyon
  Lyon, France Recruiting
• Centre Cardiologique du Nord
  Paris, France Recruiting
• Segeberger Kliniken GMBH / Herz- und Gefäßzentrum
  Bad Segeberg, Germany Recruiting
• Miedziowe Centrum Zdrowia
  Lubin, Poland Recruiting
• Regional Specialist Hospital
  Wroclaw, Poland Recruiting
• La Paz University Hospital
  Madrid, Spain Recruiting

Study contacts

• Study coordinator: Jasper Yang
• Email: cm@shunmed.com
• Phone: 008615363476127

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.