ShockFast Intravascular Lithotripsy Device for Treatment of Calcified Coronary Lesions

Official title

ShockFast Intravascular Lithotripsy Device for Treatment of Calcified Coronary Lesions, a Prospective, Randomised, International Trial: ShockFast IVL Trial

Overview

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.

Detailed description

Coronary calcified lesions have evolved as one of the most challenging indications for coronary percutaneous interventions (PCI). Different dedicated devices have been recently introduced into the market to improve procedural success in this challenging PCI population. Shockwave Intravascular Lithotripsy, (Shockwave IVL), Shockwave Medical, SC, CA, USA, was the first intracoronary device that used sonic pressure to fracture intracoronary calcium. The device safety and efficacy has been proved in a series of clinical trials. ShockFast intravascular lithotripsy (ShockFast IVL), Shunmei medical, Shenzhen, China, is a new dedicated device to treat intracoronary calcium that makes use of sonic pressure waves to fracture calcified plaques. ShockFast IVL has recently obtained CE mark approval for this indication.

The aim of this study is to compare this new lithotripsy device (ShockFast IVL) with the existing and widely used lithotripsy device that uses the same principle of action, the Shockwave IVL, Shockwave Medical, SC, CA, USA.

Interventions

• Device 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.
• Device 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.

Primary outcome measures

• Stent area post PCI measured at the minimal lumen area during initial procedure, evaluated by OCT [Time frame: Hospitalisation (during procedure)]

Secondary outcome measures (3)

• 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-up]
• Angiographic success [Time frame: Hospitalisation (during procedure)]
• Device success [Time frame: Hospitalisation (during procedure)]

Eligibility criteria

Inclusion criteria

• 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 criteria

• 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
• Severe lesion tortuosity where OCT is judged impossible to cross.
• Inability to tolerate dual antiplatelet therapy for 6 months or longer
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Poland · 4 centers

• Medical University of Silesia — Katowice
• University Hospital Krakow — Krakow
• Miedziowe Centrum Zdrowia — Lubin
• Regional Specialist Hospital — Wroclaw

Spain · 4 centers

• La Paz University Hospital — Madrid
• La Princesa Univeristy Hospital — Madrid
• Virgen Arrixaca University Clinical Hospital — Murcia
• Virgen del Rocío University Hospital — Seville

France · 3 centers

• Infirmerie Protestante de Lyon — Lyon
• Centre Cardiologique du Nord — Paris
• Centre Hospitalier de Valenciennes — Valenciennes

Identifiers

NCT: NCT07407738 · 3W RCG 1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗