Coronary Artery DiseaseNCT03328949
Shockwave Coronary Lithoplasty® Study (Disrupt CAD II)
A study testing IVL Coronary Lithotripsy System in people with Coronary Artery Disease, run by Shockwave Medical, Inc. at 15 sites in 9 countries.
Trial summary
The objective of this post market study is to examine the safety and performance of the Shockwave Coronary Intravascular Lithotripsy System for the treatment of narrowed coronary arteries before the doctor places a stent. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- IVL Coronary Lithotripsy System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 15 sitesin 9 countries
- Study dates
- 18 May 2018to 25 Apr 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patient is ≥ 18 years of age
- Troponin must be less than or equal to the upper limit of lab normal value within 24 hours prior to the procedure OR if troponin is elevated, concomitant CK must be normal
- The target vessel must have a TIMI flow 3 at baseline
- Patients with significant (≥ 50% diameter stenosis) native coronary artery disease including stable or unstable angina and silent ischemia, suitable for PCI
- Ability to tolerate dual antiplatelet agent (i.e. aspirin, clopidogrel, prasugrel, or ticagrelor) for 1 year and single antiplatelet therapy for life
- Single lesion stenosis of protected LMCA, or LAD, RCA or LCX artery ≥50% in a reference vessel of 2.5 mm - 4.0 mm diameter and ≤ 32 mm length
Show all 11Show fewer
- Presence of calcification within the lesion on both sides of the vessel as assessed by angiography
- Planned treatment of single lesion in one vessel
- Ability to pass a 0.014" guide wire across the lesion
- Patient, or authorized representative, signs a written Informed Consent form to participate in the study, prior to any study-mandated procedures
- Patient is able and willing to comply with all assessments in the study
Who cannot join
- Concomitant use of Atherectomy, Specialty balloon, or investigational coronary devices
- Prior PCI procedure within the last 30 days of the index procedure
- Patient has planned cardiovascular interventions within 30 days post index procedure
- Second lesion with ≥50% stenosis in the same target vessel
- Left ventricular ejection fraction < 40%
- Patient refusing or not a candidate for emergency coronary artery bypass grafting (CABG) surgery
Show all 31Show fewer
- Uncontrolled severe hypertension (systolic BP >180 mm Hg or diastolic BP >110 mm Hg)
- Severe renal failure with serum creatinine >2.5 mg/dL, unless on chronic dialysis
- Untreated pre-procedural hemoglobin <10 g/dL
- Coagulopathy manifested by platelet count <100,000 or International Normalized ratio (INR) >1.7 (INR is only required in patients who have taken warfarin within 2 weeks of enrollment)
- Patients in cardiogenic shock
- Acute myocardial infarction (MI) within the past one (1) month, and/or signs of active myocardial ischemia at the time of enrollment including elevated Troponin-I or T (with concomitant elevation of CK), ischemic ECG changes or chest pain
- History of a stroke or transient ischemic attack (TIA) within 3 months
- NYHA class III or IV heart failure
- Active peptic ulcer or upper gastrointestinal (GI) bleeding within 6 months
- Patients with a life expectancy of less than 1 year
- Target vessel < 2.4 mm in diameter
- Target lesion > 32 mm in length
- Chronic Total Occlusion (CTO)
- Previous stent procedure within 5 mm of target lesion
- Angiographic evidence of a target lesion severe dissection prior to Coronary Lithoplasty treatment
- Unprotected Left Main diameter stenosis ≥ 50%
- Visible thrombus (by angiography) at target lesion site
- Target lesion is located in a native vessel distal to anastomosis with a saphenous vein graft or LIMA/RIMA bypass
- Patient has active systemic infection
- Patient has connective tissue disease (e.g., Marfan's syndrome)
- Patient has a hypercoagulable disorder
- Uncontrolled insulin dependent diabetes
- Patient has allergy to imaging contrast media for which they cannot be pre-medicated
- Evidence of aneurysm in target vessel
- Patient is pregnant or nursing
Trial locations and contacts
15 sites in 9 countries.
15 sites in 9 countries
Germany3 sites
Universitaets-Herzzentrum Freiburg- Bad Krozingen
Bad Krozingen
Universitaetsklinikum Bonn
Bonn
UKGM Universitaetsklinikum Giessen
Giessen
France2 sites
Institut Hospitalier Jacques Cartier
Massy
Clinique Pasteur
Toulouse
Italy2 sites
AOU Careggi SOD Interventistica
Florence
San Raffaelle Hospital
Milan
Netherlands2 sites
Thorax Center, Erasmus MC
Rotterdam
Isala Zeikenhuis- Hartecentrum
Zwolle
United Kingdom2 sites
King's College Hospital
London
Oxford University Hospitals, John Radcliffe Hospital
Oxford
About this study
Official title: Prospective Multi-Center, Single Arm Post-Market Study (PMS) of the Shockwave Medical, Inc. Coronary Lithoplasty® System in Coronary Arteries
The objective of this post market study is to examine the safety and performance of the Shockwave Coronary Intravascular Lithotripsy System for the treatment of narrowed coronary arteries before the doctor places a stent.
Read the detailed description
The study will be conducted at 15 sites in Europe and up to 120 participants will be followed for 30 days post procedure.
Patients ≥18 years of age scheduled for stent procedure with evidence of significant calcified stenosis of left main, or left anterior descending, right coronary artery or left circumflex will be eligible to enroll in the study. The primary endpoint of the study will evaluate major adverse cardiac events post procedure including 1) cardiac related death, 2) heart attack, and 3) intervention to treat the coronary artery that was previously treated at the procedure visit.
- Conditions
- Coronary Artery Disease
- Being tested
- IVL Coronary Lithotripsy System
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVL Coronary Lithotripsy SystemDevice
The coronary intravascular lithotripsy catheter is similar to other balloon devices that are routinely used during angioplasty procedures; however, it has electrodes inside the balloon which are designed to deliver energy to crack the calcified blockage using lithotripsy (acoustic energy).
| Study group | Role | What they receive |
|---|---|---|
| IVL Coronary Lithotripsy System | Experimental | All enrolled patients will receive treatment from the IVL coronary lithotripsy system prior to coronary stent placement. Receives: Device: IVL Coronary Lithotripsy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With In-hospital Major Adverse Cardiac Events (MACE)
The primary endpoint is the frequency of in-hospital major adverse cardiac events (MACE). MACE is defined as the following:
- Cardiac death
- Myocardial Infarction - defined as a CK-MB level > 3 times the upper limit of lab normal (ULN) value with or without new pathologic Q wave
- TVR - defined as revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure
Measured: Post-procedure through hospital discharge
Secondary outcomes (3)
Number of Participants With Clinical Success
Performance will be assessed by the ability of the Lithotripsy System to produce acceptable residual stenosis (<50%) after stenting with no evidence of in-hospital MACE. Each patient that achieves both of these requirements will be considered a "clinical success", and the rate of clinical success among subjects will be evaluated.
Measured: During procedure through hospital discharge
Number of Participants With Angiographic Success
Angiographic success defined as success in facilitating stent delivery with <50% residual stenosis and without serious angiographic complications. Serious angiographic complications defined as severe dissection (Type D to F), perforation, abrupt closure, and persistent slow flow or persistent no reflow.
Measured: During procedure
Number of Participants Which Experienced Cardiac Death
Number of patients who experienced a cardiac death at 30 days post-procedure.
Measured: 30 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2017
- Study start18 May 2018
- Primary completion26 Mar 2019
- Study completion25 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery 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
- Not applicable
- Intervention model
- Single group
- Model description
- Intravascular Coronary Lithotripsy System
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shockwave Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean Fajadet, MD, Principal investigator, Clinic PasteurCarlo DiMario, MD, Principal investigator, University of Florence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03328949
- Sponsor's protocol ID
- CP61774
- Status last verified
- Nov 2019
- First submitted
- 27 Oct 2017
- Last updated
- 19 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kereiakes DJ, Di Mario C, Riley RF, Fajadet J, Shlofmitz RA, Saito S, Ali ZA, Klein AJ, Price MJ, Hill JM, Stone GW. Intravascular Lithotripsy for Treatment of Calcified Coronary Lesions: Patient-Level Pooled Analysis of the Disrupt CAD Studies. JACC Cardiovasc Interv. 2021 Jun 28;14(12):1337-1348. doi: 10.1016/j.jcin.2021.04.015. Epub 2021 May 3.
PubMed 33939604Ali ZA, Nef H, Escaned J, Werner N, Banning AP, Hill JM, De Bruyne B, Montorfano M, Lefevre T, Stone GW, Crowley A, Matsumura M, Maehara A, Lansky AJ, Fajadet J, Di Mario C. Safety and Effectiveness of Coronary Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Stenoses: The Disrupt CAD II Study. Circ Cardiovasc Interv. 2019 Oct;12(10):e008434. doi: 10.1161/CIRCINTERVENTIONS.119.008434. Epub 2019 Sep 25.
PubMed 31553205
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multi-Center, Single Arm Post-Market Study (PMS) of the Shockwave Medical, Inc. Coronary Lithoplasty® System in Coronary Arteries
- ClinicalTrials.gov ID
- NCT03328949
- Acronym / sponsor ID
- CP61774
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Shockwave Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 May 2018 (actual)
- Primary completion
- 26 Mar 2019 (actual)
- Study completion
- 25 Apr 2019 (actual)
- First posted
- 1 Nov 2017 (actual)
- Results
- Posted 8 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this post market study is to examine the safety and performance of the Shockwave Coronary Intravascular Lithotripsy System for the treatment of narrowed coronary arteries before the doctor places a stent.
Detailed description
The study will be conducted at 15 sites in Europe and up to 120 participants will be followed for 30 days post procedure.
Patients ≥18 years of age scheduled for stent procedure with evidence of significant calcified stenosis of left main, or left anterior descending, right coronary artery or left circumflex will be eligible to enroll in the study. The primary endpoint of the study will evaluate major adverse cardiac events post procedure including 1) cardiac related death, 2) heart attack, and 3) intervention to treat the coronary artery that was previously treated at the procedure visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Intravascular Coronary Lithotripsy System
| Arm | Type | Receives |
|---|---|---|
| IVL Coronary Lithotripsy System | Experimental | Device: IVL Coronary Lithotripsy SystemAll enrolled patients will receive treatment from the IVL coronary lithotripsy system prior to coronary stent placement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patient is ≥ 18 years of age
- Troponin must be less than or equal to the upper limit of lab normal value within 24 hours prior to the procedure OR if troponin is elevated, concomitant CK must be normal
- The target vessel must have a TIMI flow 3 at baseline
- Patients with significant (≥ 50% diameter stenosis) native coronary artery disease including stable or unstable angina and silent ischemia, suitable for PCI
- Ability to tolerate dual antiplatelet agent (i.e. aspirin, clopidogrel, prasugrel, or ticagrelor) for 1 year and single antiplatelet therapy for life
Key exclusion criteria (31 listed)
- Concomitant use of Atherectomy, Specialty balloon, or investigational coronary devices
- Prior PCI procedure within the last 30 days of the index procedure
- Patient has planned cardiovascular interventions within 30 days post index procedure
- Second lesion with ≥50% stenosis in the same target vessel
- Left ventricular ejection fraction < 40%
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 |
|---|---|---|
| IVL Coronary Lithotripsy SystemThe coronary intravascular lithotripsy catheter is similar to other balloon devices that are routinely used during angioplasty procedures; however, it has electrodes inside the balloon which are designed to deliver energy to crack the calcified blockage using lithotripsy (acoustic energy). | Device | IVL Coronary Lithotripsy System |
Primary outcome
Number of Participants With In-hospital Major Adverse Cardiac Events (MACE)
Time frame: Post-procedure through hospital discharge
The primary endpoint is the frequency of in-hospital major adverse cardiac events (MACE). MACE is defined as the following: * Cardiac death * Myocardial Infarction - defined as a CK-MB level > 3 times the upper limit of lab normal (ULN) value with or without new pathologic Q wave * TVR - defined as revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure
3 secondary outcomes
Number of Participants With Clinical Success
Time frame: During procedure through hospital discharge
Number of Participants With Angiographic Success
Time frame: During procedure
Number of Participants Which Experienced Cardiac Death
Time frame: 30 days post-procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33939604Kereiakes DJ, Di Mario C, Riley RF, Fajadet J, Shlofmitz RA, Saito S, Ali ZA, Klein AJ, Price MJ, Hill JM, Stone GW. Intravascular Lithotripsy for Treatment of Calcified Coronary Lesions: Patient-Level Pooled Analysis of the Disrupt CAD Studies. JACC Cardiovasc Interv. 2021 Jun 28;14(12):1337-1348. doi: 10.1016/j.jcin.2021.04.015. Epub 2021 May 3.
- Derived from this study: PubMed 31553205Ali ZA, Nef H, Escaned J, Werner N, Banning AP, Hill JM, De Bruyne B, Montorfano M, Lefevre T, Stone GW, Crowley A, Matsumura M, Maehara A, Lansky AJ, Fajadet J, Di Mario C. Safety and Effectiveness of Coronary Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Stenoses: The Disrupt CAD II Study. Circ Cardiovasc Interv. 2019 Oct;12(10):e008434. doi: 10.1161/CIRCINTERVENTIONS.119.008434. Epub 2019 Sep 25.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Jean Fajadet, MD principal investigator
Clinic Pasteur
Carlo DiMario, MD principal investigator
University of Florence
15 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IVL Coronary Lithotripsy System in people with Coronary Artery Disease, run by Shockwave Medical, Inc. at 15 sites in 9 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 11 inclusion and 31 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: finished, as of the sponsor's last update on 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Germany, France, Italy, Netherlands, United Kingdom and 4 more countries. 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?
Yes. Results are posted in the registry (first posted 8 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With In-hospital Major Adverse Cardiac Events (MACE) (time frame: Post-procedure through hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03328949, which also lists 2 linked publications.
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 19 Nov 2019.