ShockFast Intravascular Lithotripsy Device for Treatment of Calcified Coronary Lesions

NCT07407738 | Not Yet Recruiting DMC

• 1 other identifier: 3W RCG 1
• Study Type: interventional
• Target: 120
• Locations: 3 countries
• Sites: 11

Brief 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.

Conditions

Coronary Arterial Disease; Calcified Coronary Artery Disease

Keywords

Shockwave Intravascular Lithotripsy; Shockfast Intravascular Lithotripsy; Coronary Calcified Lesion; IVL

Outcome Measures

Primary Outcomes (1)

• Stent area post PCI measured at the minimal lumen area during initial procedure, evaluated by OCT

  Hospitalisation (during procedure)

Secondary Outcomes (3)

• Target lesion failure defined as cardiac death, target-vessel myocardial infarction and target-lesion revascularisation at discharge and 30 days

  30 day follow-up

• Angiographic success

  Hospitalisation (during procedure)

• Device success

  Hospitalisation (during procedure)

Study Arms (2)

Shockfast IVL

EXPERIMENTAL

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.

Device: Shockfast IVL

Shockwave IVL

ACTIVE COMPARATOR

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: Shockwave IVL

Interventions

Shockwave IVL DEVICE

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.

Shockwave IVL

Shockfast IVL DEVICE

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.

Shockfast IVL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shunmei Medical: lead

Study Sites (11)

Infirmerie Protestante de Lyon

Lyon, France

Location

Centre Cardiologique du Nord

Paris, France

Location

Centre Hospitalier de Valenciennes

Valenciennes, France

Location

Medical University of Silesia

Katowice, Poland

Location

University Hospital Krakow

Krakow, Poland

Location

Miedziowe Centrum Zdrowia

Lubin, Poland

Location

Regional Specialist Hospital

Wroclaw, Poland

Location

La Paz University Hospital

Madrid, Spain

Location

La Princesa Univeristy Hospital

Madrid, Spain

Location

Virgen Arrixaca University Clinical Hospital

Murcia, Spain

Location

Virgen del Rocío University Hospital

Seville, Spain

Location

Central Study Contacts

Jasper Yang

CONTACT

008615363476127; cm@shunmed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 12, 2026
• Study Start: February 28, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3); ES (4); PL (4)