Coronary Arterial DiseaseIVLNCT07407738
ShockFast Intravascular Lithotripsy Device for Treatment of Calcified Coronary Lesions
A study testing Shockwave IVL and Shockfast IVL in people with Coronary Arterial Disease and Calcified Coronary Artery Disease, run by Shunmei Medical at 13 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Arterial Disease, Calcified Coronary Artery Disease
- What is being tested?
- Shockwave IVL and Shockfast IVL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 13 sitesin 4 countries
- Study dates
- 16 Feb 2026to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 13Show fewer
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
13 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
13 sites in 4 countries
Poland4 sites, 4 recruiting
- Not yet recruiting
Medical University of Silesia
Katowice
Prof. Wojakowski
- Not yet recruiting
University Hospital Krakow
Krakow
Prof. Bartus
- Recruiting
Miedziowe Centrum Zdrowia
Lubin
Dr. Wlodarczak
- Recruiting
Regional Specialist Hospital
Wroclaw
Prof. Roleder
Spain4 sites, 4 recruiting
- Recruiting
La Paz University Hospital
Madrid
Dr. Moreno
- Recruiting
La Princesa Univeristy Hospital
Madrid
Dr. Alfonso
- Recruiting
Virgen Arrixaca University Clinical Hospital
Murcia
Dr. Pinar
- Recruiting
Virgen del Rocío University Hospital
Seville
Dr. Diaz
France3 sites, 2 recruiting
- Recruiting
Infirmerie Protestante de Lyon
Lyon
Dr. Faurie
- Recruiting
Centre Cardiologique du Nord
Paris
Dr. Digne
- Withdrawn
Centre Hospitalier de Valenciennes
Valenciennes
Germany2 sites, 2 recruiting
- Recruiting
Segeberger Kliniken GMBH / Herz- und Gefäßzentrum
Bad Segeberg
Holger Prof. Nef
Prof. Nef
- Not yet recruiting
MediClin Heart Center Lahr
Lahr
Kambis Prof. Mashayekhi
Prof. Mashayekhi
About this study
Official title: ShockFast Intravascular Lithotripsy Device for Treatment of Calcified Coronary Lesions, a Prospective, Randomised, International Trial: ShockFast IVL 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.
Read the 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.
- Being tested
- Shockwave IVL, Shockfast IVL
- Keywords
- Shockwave Intravascular Lithotripsy, Shockfast Intravascular Lithotripsy, Coronary Calcified Lesion, IVL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shockwave IVLDevice
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 IVLDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Shockwave IVL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stent area post PCI measured at the minimal lumen area during initial procedure, evaluated by OCT
Measured: 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
Measured: 30 day follow-up
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)
Measured: Hospitalisation (during procedure)
Device success
Defined as success of the device to cross and fully expand
Measured: Hospitalisation (during procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start16 Feb 2026
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shunmei Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07407738
- Sponsor's protocol ID
- 3W RCG 1
- Acronym
- IVL
- Status last verified
- Sep 2026
- First submitted
- 29 Jan 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ShockFast Intravascular Lithotripsy Device for Treatment of Calcified Coronary Lesions, a Prospective, Randomised, International Trial: ShockFast IVL Trial
- ClinicalTrials.gov ID
- NCT07407738
- Acronym / sponsor ID
- IVL / 3W RCG 1
- Keywords
- Shockwave Intravascular Lithotripsy, Shockfast Intravascular Lithotripsy, Coronary Calcified Lesion, IVL
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shunmei MedicalIndustry (pharma, biotech, devices)
- Study start
- 16 Feb 2026 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shockfast IVL | Experimental | Device: Shockfast IVLInterventional 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. |
| Shockwave IVL | Active comparator | Device: Shockwave IVLInterventional 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
- Severe Calcification:
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shockwave IVLTreatment 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 | Shockwave IVL |
| Shockfast IVLTreatment 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. | Device | Shockfast IVL |
Primary outcome
Stent area post PCI measured at the minimal lumen area during initial procedure, evaluated by OCT
Time frame: Hospitalisation (during procedure)
3 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Coronary Arterial Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
13 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shockwave IVL and Shockfast IVL in people with Coronary Arterial Disease and Calcified Coronary Artery Disease, run by Shunmei Medical at 13 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Poland, Spain, France, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jasper Yang (008615363476127, cm@shunmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stent area post PCI measured at the minimal lumen area during initial procedure, evaluated by OCT (time frame: Hospitalisation (during procedure)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.