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AzTrials

Coronary Artery DiseaseNCT03595176

Disrupt CAD III With the Shockwave Coronary IVL System

A study testing Lithotripsy in people with Coronary Artery Disease and Myocardial Infarction, run by Shockwave Medical, Inc. at 48 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The study design is a prospective, multicenter, single-arm, global IDE study to evaluate the safety and effectiveness of the Shockwave Medical Coronary Intravascular Lithotripsy (IVL) System in de novo, calcified, stenotic coronary arteries prior to stenting. Read more about this study

Who is it for?
Any age
What is being tested?
Lithotripsy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
431 participants
Where
48 sitesin 4 countries
Study dates
9 Jan 2019to 10 Apr 2022
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Subject is ≥18 years of age
  • Subjects with native coronary artery disease (including stable or unstable angina and silent ischemia) suitable for PCI
  • For patients with unstable ischemic heart disease, biomarkers (troponin or CK-MB) must be less than or equal to the upper limit of lab normal within 12 hours prior to the procedure (note: if both labs are drawn, both must be normal).
  • For patients with stable ischemic heart disease, biomarkers may be drawn prior to the procedure or at the time of the procedure from the side port of the sheath.
  • If drawn prior to the procedure, biomarkers (troponin or CK-MB) must be less than or equal to the upper limit of lab normal within 12 hours of the procedure (note: if both labs are drawn, both must be normal).
  • If biomarkers are drawn at the time of the procedure from the side port of the sheath prior to any intervention, biomarker results do not need to be analyzed prior to enrollment (note: CK-MB is required if drawn from the sheath).
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  • Left ventricular ejection fraction >25% within 6 months (note: in the case of multiple assessments of LVEF, the measurement closest to enrollment will be used for this criteria; may be assessed at time of index procedure)
  • Subject or legally authorized representative, signs a written Informed Consent form to participate in the study, prior to any study-mandated procedures
  • Lesions in non-target vessels requiring PCI may be treated either:
  • >30 days prior to the study procedure if the procedure was unsuccessful or complicated; or
  • >24 hours prior to the study procedure if the procedure was successful and uncomplicated (defined as a final lesion angiographic diameter stenosis <30% and TIMI 3 flow (visually assessed) for all non-target lesions and vessels without perforation, cardiac arrest or need for defibrillation or cardioversion or hypotension/heart failure requiring mechanical or intravenous hemodynamic support or intubation, and with no post-procedure biomarker elevation >normal; or
  • >30 days after the study procedure
  • Angiographic Inclusion Criteria
  • The target lesion must be a de novo coronary lesion that has not been previously treated with any interventional procedure
  • Single de novo target lesion stenosis of protected LMCA, or LAD, RCA or LCX (or of their branches) with:
  • Stenosis of ≥70% and <100% or
  • Stenosis ≥50% and <70% (visually assessed) with evidence of ischemia via positive stress test, or fractional flow reserve value ≤0.80, or iFR <0.90 or IVUS or OCT minimum lumen area ≤4.0 mm²
  • The target vessel reference diameter must be ≥2.5 mm and ≤4.0 mm
  • The lesion length must not exceed 40 mm
  • The target vessel must have TIMI flow 3 at baseline (visually assessed; may be assessed after pre- dilatation)
  • Evidence of calcification at the lesion site by, a) angiography, with fluoroscopic radio-opacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location and total length of calcium of at least 15 mm and extending partially into the target lesion, OR by b) IVUS or OCT, with presence of ≥270 degrees of calcium on at least 1 cross section
  • Ability to pass a 0.014" guide wire across the lesion

Who cannot join

  • Any comorbidity or condition which may reduce compliance with this protocol, including follow-up visits
  • Subject is a member of a vulnerable population as defined in 21 CFR 56.111, including individuals with mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention
  • Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint
  • Subject is pregnant or nursing (a negative pregnancy test is required for women of child-bearing potential within 7 days prior to enrollment)
  • Unable to tolerate dual antiplatelet therapy (i.e., aspirin, and either clopidogrel, prasugrel, or ticagrelor) for at least 6 months (for patients not on oral anticoagulation)
  • Subject has an allergy to imaging contrast media which cannot be adequately pre-medicated
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  • Subject experienced an acute MI (STEMI or non-STEMI) within 30 days prior to index procedure, defined as a clinical syndrome consistent with an acute coronary syndrome with troponin or CK-MB greater than 1 times the local laboratory's upper limit of normal
  • New York Heart Association (NYHA) class III or IV heart failure
  • Renal failure with serum creatinine >2.5 mg/dL or chronic dialysis
  • History of a stroke or transient ischemic attack (TIA) within 6 months, or any prior intracranial hemorrhage or permanent neurologic deficit
  • Active peptic ulcer or upper gastrointestinal (GI) bleeding within 6 months
  • Untreated pre-procedural hemoglobin <10 g/dL or intention to refuse blood transfusions if one should become necessary
  • Coagulopathy, including but not limited to platelet count <100,000 or International Normalized ratio (INR) > 1.7 (INR is only required in subjects who have taken warfarin within 2 weeks of enrollment)
  • Subject has a hypercoagulable disorder such as polycythemia vera, platelet count >750,000 or other disorders
  • Uncontrolled diabetes defined as a HbA1c greater than or equal to 10%
  • Subject has an active systemic infection on the day of the index procedure with either fever, leukocytosis or requiring intravenous antibiotics
  • Subjects in cardiogenic shock or with clinical evidence of left-sided heart failure (S3 gallop, pulmonary rales, oliguria, or hypoxemia)
  • Uncontrolled severe hypertension (systolic BP >180 mm Hg or diastolic BP >110 mm Hg)
  • Subjects with a life expectancy of less than 1 year
  • Non-coronary interventional or surgical structural heart procedures (e.g., TAVR, MitraClip, LAA or PFO occlusion, etc.) within 30 days prior to the index procedure
  • Planned non-coronary interventional or surgical structural heart procedures (e.g., TAVR, MitraClip, LAA or PFO occlusion, etc.) within 30 days after the index procedure
  • Subject refusing or not a candidate for emergency coronary artery bypass grafting (CABG) surgery
  • Planned use of atherectomy, scoring or cutting balloon, or any investigational device other than lithotripsy
  • High SYNTAX Score (≥33) if assessed as standard of care, unless the local heart team has met and recommends PCI is the most appropriate treatment for the patient
  • Unprotected left main diameter stenosis >30%
  • Target vessel is excessively tortuous defined as the presence of two or more bends >90º or three or more bends >75º
  • Definite or possible thrombus (by angiography or intravascular imaging) in the target vessel
  • Evidence of aneurysm in target vessel within 10 mm of the target lesion
  • Target lesion is an ostial location (LAD, LCX, or RCA, within 5 mm of ostium) or an unprotected left main lesion
  • Target lesion is a bifurcation with ostial diameter stenosis ≥30%
  • Second lesion with >50% stenosis in the same target vessel as the target lesion including its side branches
  • Target lesion is located in a native vessel that can only be reached by going through a saphenous vein or arterial bypass graft
  • Previous stent within the target vessel implanted within the last year
  • Previous stent within 10 mm of the target lesion regardless of the timing of its implantation
  • Angiographic evidence of a dissection in the target vessel at baseline or after guidewire passage

Trial locations and contacts

48 sites in 4 countries.

48 sites in 4 countries

United States39 sites

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • Piedmont Heart Institute

    Atlanta, Georgia, 30309

  • MedStar Union Memorial Hospital

    Baltimore, Maryland, 21218

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Deborah Heart and Lung Center

    Browns Mills, New Jersey, 08015

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19096

  • University of Vermont

    Burlington, Vermont, 05401

  • Charleston Area Medical Center (CAMC) - Health Education & Research Institute

    Charleston, West Virginia, 25304

  • Northwestern University

    Chicago, Illinois, 60611

  • The Christ Hospital

    Cincinnati, Ohio, 45219

  • Baylor Heart and Vascular Hospital

    Dallas, Texas, 75226

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Durham VA Health Care System

    Durham, North Carolina, 27705

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • St. Vincent Heart Center of Indiana, LLC

    Indianapolis, Indiana, 46290

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

  • Scripps Clinic

    La Jolla, California, 92037

  • University of California, San Diego (UCSD) - Medical Center

    La Jolla, California, 92037

  • Minneapolis Heart Institute

    Minneapolis, Minnesota, 55407

  • Yale New Haven Hospital

    New Haven, Connecticut, 06520

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • New York University (NYU) Langone Medical Center

    New York, New York, 10016

  • Columbia University Medical Center/ New York Presbyterian

    New York, New York, 10065

  • Advocate Health and Hospitals Corporation - Edward Hospital

    Oakbrook Terrace, Illinois, 60540

  • St. Joseph Hospital

    Orange, California, 92868

  • VA Palo Alto Health Care System

    Palo Alto, California, 94304

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • The Miriam Hospital

    Providence, Rhode Island, 02906

  • NC Heart and Vascular

    Raleigh, North Carolina, 27607

  • St. Francis Hospital

    Roslyn, New York, 11576

  • Honor Health

    Scottsdale, Arizona, 85258

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • North Mississippi Medical Center

    Tupelo, Mississippi, 38801

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Pinnacle Health Cardiovascular Institute Inc.

    Wormleysburg, Pennsylvania, 17043

Other trials in United States

France3 sites

  • Clinique des Domes - Pole Sante Republique

    Clermont-Ferrand, 63050

  • Institute Cardiovasculaire Paris Sud

    Massy, 91300

  • Clinique Pasteur

    Toulouse, Cedex 3, 31076

Other trials in France

Germany3 sites

  • Charité - Universitaetsmedizin Berlin

    Berlin, 12203

  • Universitaetsklinikum Giessen and Marburg GmbH

    Marburg, CET

  • Rheinland Klinikum Neuss GmbH - Lukaskrankenhaus Neuss

    Neuss, 41464

Other trials in Germany

United Kingdom3 sites

  • Golden Jubilee National Hospital

    Clydebank, G81 4DY

  • St. Bartholomew's Hospital

    London, EC1A 7BE

  • King's College Hospital

    London, SE5 9RS

Other trials in United Kingdom

About this study

Official title: Prospective, Multicenter, Single-Arm, Global IDE Study of the Shockwave Coronary Intravascular Lithotripsy (IVL) System With the Shockwave C2 Coronary IVL Catheter in Calcified Coronary Arteries

The study design is a prospective, multicenter, single-arm, global IDE study to evaluate the safety and effectiveness of the Shockwave Medical Coronary Intravascular Lithotripsy (IVL) System in de novo, calcified, stenotic coronary arteries prior to stenting. Disrupt CAD III is being conducted as a staged pivotal study.

Read the detailed description

Subject Population: Subjects ≥ 18 years of age with de novo, calcified coronary artery lesions presenting with stable, unstable or silent ischemia that are suitable for percutaneous coronary intervention (PCI). Approximately 392 subjects at 50 sites will be enrolled. A minimum of 50% of the total enrollment will come from the United States.Subjects will be followed through discharge, 30 days, 6, 12 and 24 months.

Being tested
Lithotripsy
Keywords
Intravascular Lithotripsy, Percutaneous Coronary Intervention
Medical subject headings
Coronary Artery Disease, Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LithotripsyDevice

    Deliver Lithotripsy to the target vessel prior to placing a coronary stent.

Study groups in NCT03595176
Study groupRoleWhat they receive
Coronary Lithotripsy SystemExperimentalAll subjects will receive lithotripsy treatment from the Shockwave Medical Coronary IVL System
Receives: Device: Lithotripsy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Who Experienced Freedom From Major Adverse Cardiac Events (MACE) Within 30 Days Post-procedure

    The primary safety endpoint was freedom from MACE at 30 days - a composite of cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR). The primary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 30 days of index procedure

  2. Number of Participants With Procedural Success (Residual Stenosis <50%)

    The primary effectiveness endpoint was Procedural Success defined as stent delivery with a residual in-stent stenosis <50% (core laboratory assessed) and without in-hospital MACE. The primary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: 12-24 hours post procedure or at discharge, whichever is earlier, but at least 6 hours post procedure

Secondary outcomes (68)

  1. Number of Participants With Device Crossing Success

    Device Crossing Success defined as the ability to deliver the IVL catheter across the target lesion, and delivery of lithotripsy without serious angiographic complications immediately after IVL. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: at end of procedure

  2. Number of Participants With Angiographic Success (Residual Stenosis <50%)

    Angiographic Success defined as stent delivery with <50% residual stenosis and without serious angiographic complications. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: at end of procedure

  3. Number of Participants With Procedural Success (Residual Stenosis <=30%)

    Procedural Success defined as stent delivery with a residual stenosis <=30% (core laboratory assessed) and without in-hospital MACE. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: 12-24 hours post procedure or at discharge, whichever is earlier, but at least 6 hours post procedure

  4. Number of Participants With Angiographic Success (Residual Stenosis <=30%)

    Angiographic Success defined as stent delivery with <=30% residual stenosis and without serious angiographic complications. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: at end of procedure

  5. Number of Participants With 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. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: at end of procedure

  6. MACE Rate at 6 Months

    MACE at 6 months - a composite of cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR) - is presented as a Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 6 months of index procedure

  7. MACE Rate at 12 Months

    MACE at 12 months - a composite of cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR) - is presented as a Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 12 months of index procedure

  8. MACE Rate at 24 Months

    MACE at 24 months - a composite of cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR) - is presented as a Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 24 months of index procedure

  9. Target Lesion Failure (TLF) Rate at 30 Days

    Target lesion failure (TLF) is defined as cardiac death, target vessel myocardial infarction (Q wave and non-Q wave), or ischemia-driven target lesion revascularization (ID-TLR) by percutaneous or surgical methods. 30 day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 30 days of index procedure

  10. Target Lesion Failure (TLF) Rate at 6 Months

    TLF is defined as cardiac death, target vessel myocardial infarction (Q wave and non-Q wave), or ischemia-driven target lesion revascularization (ID-TLR) by percutaneous or surgical methods. For 6 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 6 months of index procedure

  11. Target Lesion Failure (TLF) Rate at 12 Months

    TLF is defined as cardiac death, target vessel myocardial infarction (Q wave and non-Q wave), or ischemia-driven target lesion revascularization (ID-TLR) by percutaneous or surgical methods. For 12 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 12 months of index procedure

  12. Target Lesion Failure (TLF) Rate at 24 Months

    TLF is defined as cardiac death, target vessel myocardial infarction (Q wave and non-Q wave), or ischemia-driven target lesion revascularization (ID-TLR) by percutaneous or surgical methods. For 24 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 24 months of index procedure

  13. All-Cause Death Rate at 30 Days

    30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 30 days of index procedure

  14. All-Cause Death Rate at 6 Months

    All-cause death at 6 months is presented as a Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 6 months of index procedure

  15. All-Cause Death Rate at 12 Months

    All-cause death at 12 months is presented as a Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 12 months of index procedure

  16. All-Cause Death Rate at 24 Months

    All-cause death at 24 months is presented as a Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 24 months of index procedure

  17. Cardiac Death Rate at 30 Days

    30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 30 days of index procedure

  18. Cardiac Death Rate at 6 Months

    Cardiac death at 6 months is presented as a Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 6 months of index procedure

  19. Cardiac Death Rate at 12 Months

    Cardiac death at 12 months is presented as a Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 12 months of index procedure

  20. Cardiac Death Rate at 24 Months

    Cardiac death at 24 months is presented as a Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 24 months of index procedure

  21. MI Rate at 30 Days

    30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 30 days of index procedure

  22. MI Rate at 6 Months

    MI is presented as a Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 6 months of index procedure

  23. MI Rate at 12 Months

    MI is presented as a Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 12 months of index procedure

  24. MI Rate at 24 Months

    MI is presented as a Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 24 months of index procedure

  25. Target Vessel-Myocardial Infarction (TV-MI) Rate at 30 Days

    30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 30 days of index procedure

  26. TV-MI Rate at 6 Months

    TV-MI is presented as a Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 6 months of index procedure

  27. TV-MI Rate at 12 Months

    TV-MI is presented as a Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 12 months of index procedure

  28. TV-MI Rate at 24 Months

    TV-MI is presented as a Kaplan-Meier estimated event rate at 24 months. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 24 months of index procedure

  29. Procedural MI Rate at 30 Days

    Periprocedural MI defined as CK-MB > 3x upper limit of lab normal (ULN). 30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 30 days of index procedure

  30. Procedural MI Rate at 6 Months

    Periprocedural MI defined as CK-MB > 3x upper limit of lab normal (ULN). For 6 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 6 months of index procedure

  31. Procedural MI Rate at 12 Months

    Periprocedural MI defined as CK-MB > 3x upper limit of lab normal (ULN). For 12 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 12 months of index procedure

  32. Procedural MI Rate at 24 Months

    Periprocedural MI defined as CK-MB > 3x upper limit of lab normal (ULN). For 24 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 24 months of index procedure

  33. Non-Procedural MI Rate at 30 Days

    Non-Procedural MI defined as spontaneous MI beyond discharge (4th Universal Definition). 30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 30 days of index procedure

  34. Non-Procedural MI Rate at 6 Months

    Non-Procedural MI defined as spontaneous MI beyond discharge (4th Universal Definition). For 6 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 6 months of index procedure

  35. Non-Procedural MI Rate at 12 Months

    Non-Procedural MI defined as spontaneous MI beyond discharge (4th Universal Definition). For 12 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 12 months of index procedure

  36. Non-Procedural MI Rate at 24 Months

    Non-Procedural MI defined as spontaneous MI beyond discharge (4th Universal Definition). For 24 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 24 months of index procedure

  37. Ischemia-Driven Target Vessel Revascularization (ID-TVR) Rate at 30 Days

    30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 30 days of index procedure

  38. ID-TVR Rate at 6 Months

    For 6 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 6 months of index procedure

  39. ID-TVR Rate at 12 Months

    For 12 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 12 months of index procedure

  40. ID-TVR Rate at 24 Months

    For 24 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 24 months of index procedure

  41. Ischemia-Driven Target Lesion Revascularization (ID-TLR) Rate at 30 Days

    30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 30 days of index procedure

  42. ID-TLR Rate at 6 Months

    For 6 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 6 months of index procedure

  43. ID-TLR Rate at 12 Months

    For 12 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 12 months of index procedure

  44. ID-TLR Rate at 24 Months

    For 24 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 24 months of index procedure

  45. Non-ID-TVR Rate at 30 Days

    30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 30 days of index procedure

  46. Non-ID-TVR Rate at 6 Months

    For 6 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 6 months of index procedure

  47. Non-ID-TVR Rate at 12 Months

    For 12 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 12 months of index procedure

  48. Non-ID-TVR Rate at 24 Months

    For 24 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 24 months of index procedure

  49. Non-ID-TLR Rate at 30 Days

    30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 30 days of index procedure

  50. Non-ID-TLR Rate at 6 Months

    For 6 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 6 months of index procedure

  51. Non-ID-TLR Rate at 12 Months

    For 12 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 12 months of index procedure

  52. Non-ID-TLR Rate at 24 Months

    For 24 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 24 months of index procedure

  53. Any Revascularizations Rate at 30 Days

    Any revascularizations (ID and non-ID) at 30 days. 30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 30 days of index procedure

  54. Any Revascularizations Rate at 6 Months

    Any revascularizations (ID and non-ID) at 6 months, presented as a Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 6 months of index procedure

  55. Any Revascularizations Rate at 12 Months

    Any revascularizations (ID and non-ID) at 12 months, presented as a Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 12 months of index procedure

  56. Any Revascularizations Rate at 24 Months

    Any revascularizations (ID and non-ID) at 24 months, presented as a Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 24 months of index procedure

  57. Stent Thrombosis Rate at 30 Days

    Any stent thrombosis (definite, probable, definite or probable) according to Academic Research Consortium (ARC) criteria, as referenced from Cutlip, D.E. et al. Clinical End Points in Coronary Stent Trials. Circ. 2007.115.2344-51. 30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 30 days of index procedure

  58. Stent Thrombosis Rate at 6 Months

    Any stent thrombosis (definite, probable, definite or probable) according to Academic Research Consortium (ARC) criteria, as referenced from Cutlip, D.E. et al. Clinical End Points in Coronary Stent Trials. Circ. 2007.115.2344-51. For 6 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 6 months of index procedure

  59. Stent Thrombosis Rate at 12 Months

    Any stent thrombosis (definite, probable, definite or probable) according to Academic Research Consortium (ARC) criteria, as referenced from Cutlip, D.E. et al. Clinical End Points in Coronary Stent Trials. Circ. 2007.115.2344-51. For 12 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 12 months of index procedure

  60. Stent Thrombosis Rate at 24 Months

    Any stent thrombosis (definite, probable, definite or probable) according to Academic Research Consortium (ARC) criteria, as referenced from Cutlip, D.E. et al. Clinical End Points in Coronary Stent Trials. Circ. 2007.115.2344-51. For 24 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 24 months of index procedure

  61. Rate of MI Using the 4th Universal Definition at 30 Days

    30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 30 days of index procedure

  62. Rate of MI Using the 4th Universal Definition at 6 Months

    For 6 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 6 months of index procedure

  63. Rate of MI Using the 4th Universal Definition at 12 Months

    For 12 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 12 months of index procedure

  64. Rate of MI Using the 4th Universal Definition at 24 Months

    For 24 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 24 months of index procedure

  65. Rate of MI Using the Society for Cardiovascular Angiography and Interventions (SCAI) Definition at 30 Days

    30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 30 days of index procedure

  66. Rate of MI Using the SCAI Definition at 6 Months

    For 6 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 6 months of index procedure

  67. Rate of MI Using the SCAI Definition at 12 Months

    For 12 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 12 months of index procedure

  68. Rate of MI Using the SCAI Definition at 24 Months

    For 24 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

    Measured: within 24 months of index procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2018
  2. Study start9 Jan 2019
  3. Primary completion7 May 2020
  4. Study completion10 Apr 2022

Resources

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
The Coronary IVL System is a proprietary balloon catheter system designed to enhance stent outcomes by enabling delivery of the calcium disrupting capability of lithotripsy prior to balloon dilatation at low pressures. The Coronary IVL System consists of an IVL Balloon Catheter with two integrated pairs of lithotripsy emitters, a Lithotripsy Generator, and Connector Cable.
Masking
None (open label)
Enrolment
431 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03595176
Sponsor's protocol ID
CP 61982
Status last verified
May 2023
First submitted
22 Jun 2018
Last updated
19 May 2023
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Hill JM, Kereiakes DJ, Shlofmitz RA, Klein AJ, Riley RF, Price MJ, Herrmann HC, Bachinsky W, Waksman R, Stone GW; Disrupt CAD III Investigators. Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Artery Disease. J Am Coll Cardiol. 2020 Dec 1;76(22):2635-2646. doi: 10.1016/j.jacc.2020.09.603. Epub 2020 Oct 15.

    PubMed 33069849

  • Kereiakes DJ, Hill JM, Ben-Yehuda O, Maehara A, Alexander B, Stone GW. Evaluation of safety and efficacy of coronary intravascular lithotripsy for treatment of severely calcified coronary stenoses: Design and rationale for the Disrupt CAD III trial. Am Heart J. 2020 Jul;225:10-18. doi: 10.1016/j.ahj.2020.04.005. Epub 2020 Apr 18.

    PubMed 32470635

  • 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 33939604

Questions about this trial

What is this clinical trial studying?

A study testing Lithotripsy in people with Coronary Artery Disease and Myocardial Infarction, run by Shockwave Medical, Inc. at 48 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 22 inclusion and 35 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 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in United States, France, Germany, United Kingdom. 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 21 Jun 2021). 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 Who Experienced Freedom From Major Adverse Cardiac Events (MACE) Within 30 Days Post-procedure (time frame: within 30 days of index procedure). The study lists 2 primary outcomes in all. 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 NCT03595176, which also lists 3 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 May 2023.

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