ShockFast Intravascular Lithotripsy Device for Treatment of Calcified Coronary Lesions

NCT07407738 · tracked via the Priya Life Science Spain tracker

Sponsor

Shunmei Medical

Phase

Not applicable

Started

2026-02-16

Last updated

2026-09-29

Condition(s) studied

Coronary Arterial DiseaseCalcified Coronary Artery Disease

Investigational drug(s) / intervention(s)

Shockwave IVLShockfast IVL

Shockwave IVL: 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: 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.

Study summary

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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Stent area post PCI measured at the minimal lumen area during initial procedure, evaluated by OCT — Hospitalisation (during procedure)

Trial sites (13)

Facility	City	Region	Status
Infirmerie Protestante de Lyon	Lyon	France	Recruiting
Centre Cardiologique du Nord	Paris	France	Recruiting
Centre Hospitalier de Valenciennes	Valenciennes	France	Withdrawn
Segeberger Kliniken GMBH / Herz- und Gefäßzentrum	Bad Segeberg	Germany	Recruiting
MediClin Heart Center Lahr	Lahr	Germany	Not Yet Recruiting
Medical University of Silesia	Katowice	Poland	Not Yet Recruiting
University Hospital Krakow	Krakow	Poland	Not Yet Recruiting
Miedziowe Centrum Zdrowia	Lubin	Poland	Recruiting
Regional Specialist Hospital	Wroclaw	Poland	Recruiting
La Paz University Hospital	Madrid	Spain	Recruiting
La Princesa Univeristy Hospital	Madrid	Spain	Recruiting
Virgen Arrixaca University Clinical Hospital	Murcia	Spain	Recruiting
Virgen del Rocío University Hospital	Seville	Spain	Recruiting

Other trials for the same condition

Coronary Laser in Undilatable or Uncrossable Lesions Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07407738 on ClinicalTrials.gov ↗ ← All trials in Spain