Disrupt CAD III With the Shockwave Coronary IVL System

• ClinicalTrials.gov Identifier: NCT03595176
• Recruitment Status: Completed
• First Posted: July 23, 2018
• Results First Posted: June 21, 2021
• Last Update Posted: June 21, 2022
• Sponsor: Shockwave Medical, Inc.
• Information provided by (Responsible Party): Shockwave Medical, Inc.

Study Description

Brief 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. Disrupt CAD III is being conducted as a staged pivotal study.

Condition or disease	Intervention/treatment	Phase
Coronary Artery Disease; Myocardial Infarction	Device: Lithotripsy	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 431 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention 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)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: January 9, 2019
• Actual Primary Completion Date: May 7, 2020
• Actual Study Completion Date: April 10, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Coronary Lithotripsy System; All subjects will receive lithotripsy treatment from the Shockwave Medical Coronary IVL System	Device: Lithotripsy; Deliver Lithotripsy to the target vessel prior to placing a coronary stent.

Outcome Measures

Primary Outcome Measures :

1. 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 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.
2. Number of Participants With Procedural Success (Residual Stenosis <50%) [ Time Frame: 12-24 hours post procedure or at discharge, whichever is earlier, but at least 6 hours post procedure ]
   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.

Secondary Outcome Measures :

1. Number of Participants With Device Crossing Success [ Time Frame: at end of procedure ]
   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.
2. Number of Participants With Angiographic Success (Residual Stenosis <50%) [ Time Frame: at end of procedure ]
   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.
3. Number of Participants With Procedural Success (Residual Stenosis <=30%) [ Time Frame: 12-24 hours post procedure or at discharge, whichever is earlier, but at least 6 hours post procedure ]
   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.
4. Number of Participants With Angiographic Success (Residual Stenosis <=30%) [ Time Frame: at end of procedure ]
   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.
5. Number of Participants With Serious Angiographic Complications [ Time Frame: at end of procedure ]
   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.
6. MACE Rate at 6 Months [ Time Frame: within 6 months of index procedure ]
   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.
7. MACE Rate at 12 Months [ Time Frame: within 12 months of index procedure ]
   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.
8. Target Lesion Failure (TLF) Rate at 30 Days [ Time Frame: within 30 days of index procedure ]
   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.
9. Target Lesion Failure (TLF) Rate at 6 Months [ Time Frame: within 6 months of index procedure ]
   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.
10. Target Lesion Failure (TLF) Rate at 12 Months [ Time Frame: within 12 months of index procedure ]
    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.
11. All-Cause Death Rate at 30 Days [ Time Frame: within 30 days of index procedure ]
    30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.
12. All-Cause Death Rate at 6 Months [ Time Frame: within 6 months of index procedure ]
    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.
13. All-Cause Death Rate at 12 Months [ Time Frame: within 12 months of index procedure ]
    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.
14. Cardiac Death Rate at 30 Days [ Time Frame: within 30 days of index procedure ]
    30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.
15. Cardiac Death Rate at 6 Months [ Time Frame: within 6 months of index procedure ]
    Cardiac death at 6 months is presented as a Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Pivotal Analysis Set.
16. Cardiac Death Rate at 12 Months [ Time Frame: within 12 months of index procedure ]
    Cardiac death at 12 months is presented as a Kaplan-Meier estimated event rate. The secondary endpoints were analyzed using the Pivotal Analysis Set.
17. MI Rate at 30 Days [ Time Frame: within 30 days of index procedure ]
    30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.
18. MI Rate at 6 Months [ Time Frame: within 6 months of index procedure ]
    MI is presented as a Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Pivotal Analysis Set.
19. MI Rate at 12 Months [ Time Frame: within 12 months of index procedure ]
    MI is presented as a Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Pivotal Analysis Set.
20. Target Vessel-Myocardial Infarction (TV-MI) Rate at 30 Days [ Time Frame: within 30 days of index procedure ]
    30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.
21. TV-MI Rate at 6 Months [ Time Frame: within 6 months of index procedure ]
    TV-MI is presented as a Kaplan-Meier estimated event rate at 6 months. The secondary endpoints were analyzed using the Pivotal Analysis Set.
22. TV-MI Rate at 12 Months [ Time Frame: within 12 months of index procedure ]
    TV-MI is presented as a Kaplan-Meier estimated event rate at 12 months. The secondary endpoints were analyzed using the Pivotal Analysis Set.
23. Procedural MI Rate at 30 Days [ Time Frame: within 30 days of index procedure ]
    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.
24. Procedural MI Rate at 6 Months [ Time Frame: within 6 months of index procedure ]
    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.
25. Procedural MI Rate at 12 Months [ Time Frame: within 12 months of index procedure ]
    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.
26. Non-Procedural MI Rate at 30 Days [ Time Frame: within 30 days of index procedure ]
    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.
27. Non-Procedural MI Rate at 6 Months [ Time Frame: within 6 months of index procedure ]
    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.
28. Non-Procedural MI Rate at 12 Months [ Time Frame: within 12 months of index procedure ]
    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.
29. Ischemia-Driven Target Vessel Revascularization (ID-TVR) Rate at 30 Days [ Time Frame: within 30 days of index procedure ]
    30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.
30. ID-TVR Rate at 6 Months [ Time Frame: within 6 months of index procedure ]
    For 6 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.
31. ID-TVR Rate at 12 Months [ Time Frame: within 12 months of index procedure ]
    For 12 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.
32. Ischemia-Driven Target Lesion Revascularization (ID-TLR) Rate at 30 Days [ Time Frame: within 30 days of index procedure ]
    30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.
33. ID-TLR Rate at 6 Months [ Time Frame: within 6 months of index procedure ]
    For 6 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.
34. ID-TLR Rate at 12 Months [ Time Frame: within 12 months of index procedure ]
    For 12 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.
35. Non-ID-TVR Rate at 30 Days [ Time Frame: within 30 days of index procedure ]
    30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.
36. Non-ID-TVR Rate at 6 Months [ Time Frame: within 6 months of index procedure ]
    For 6 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.
37. Non-ID-TVR Rate at 12 Months [ Time Frame: within 12 months of index procedure ]
    For 12 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.
38. Non-ID-TLR Rate at 30 Days [ Time Frame: within 30 days of index procedure ]
    30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.
39. Non-ID-TLR Rate at 6 Months [ Time Frame: within 6 months of index procedure ]
    For 6 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.
40. Non-ID-TLR Rate at 12 Months [ Time Frame: within 12 months of index procedure ]
    For 12 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.
41. Any Revascularizations Rate at 30 Days [ Time Frame: within 30 days of index procedure ]
    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.
42. Any Revascularizations Rate at 6 Months [ Time Frame: within 6 months of index procedure ]
    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.
43. Any Revascularizations Rate at 12 Months [ Time Frame: within 12 months of index procedure ]
    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.
44. Stent Thrombosis Rate at 30 Days [ Time Frame: within 30 days of index procedure ]
    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.
45. Stent Thrombosis Rate at 6 Months [ Time Frame: within 6 months of index procedure ]
    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.
46. Stent Thrombosis Rate at 12 Months [ Time Frame: within 12 months of index procedure ]
    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.
47. Rate of MI Using the 4th Universal Definition at 30 Days [ Time Frame: within 30 days of index procedure ]
    30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.
48. Rate of MI Using the 4th Universal Definition at 6 Months [ Time Frame: within 6 months of index procedure ]
    For 6 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.
49. Rate of MI Using the 4th Universal Definition at 12 Months [ Time Frame: within 12 months of index procedure ]
    For 12 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.
50. Rate of MI Using the Society for Cardiovascular Angiography and Interventions (SCAI) Definition at 30 Days [ Time Frame: within 30 days of index procedure ]
    30-day rates are presented as proportions. The secondary endpoints were analyzed using the Pivotal Analysis Set.
51. Rate of MI Using the SCAI Definition at 6 Months [ Time Frame: within 6 months of index procedure ]
    For 6 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.
52. Rate of MI Using the SCAI Definition at 12 Months [ Time Frame: within 12 months of index procedure ]
    For 12 months, rates are presented as Kaplan-Meier estimated event rates. The secondary endpoints were analyzed using the Pivotal Analysis Set.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Subject is ≥18 years of age
2. Subjects with native coronary artery disease (including stable or unstable angina and silent ischemia) suitable for PCI
3. 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).

4. 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.

   1. 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).
   2. 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).
5. 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)
6. Subject or legally authorized representative, signs a written Informed Consent form to participate in the study, prior to any study-mandated procedures

7. Lesions in non-target vessels requiring PCI may be treated either:

   1. >30 days prior to the study procedure if the procedure was unsuccessful or complicated; or
   2. >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
   3. >30 days after the study procedure

   Angiographic Inclusion Criteria

8. The target lesion must be a de novo coronary lesion that has not been previously treated with any interventional procedure

9. Single de novo target lesion stenosis of protected LMCA, or LAD, RCA or LCX (or of their branches) with:

   1. Stenosis of ≥70% and <100% or
   2. 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
10. The target vessel reference diameter must be ≥2.5 mm and ≤4.0 mm
11. The lesion length must not exceed 40 mm
12. The target vessel must have TIMI flow 3 at baseline (visually assessed; may be assessed after pre- dilatation)
13. 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
14. Ability to pass a 0.014" guide wire across the lesion

Exclusion Criteria:

1. Any comorbidity or condition which may reduce compliance with this protocol, including follow-up visits
2. 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
3. Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint
4. Subject is pregnant or nursing (a negative pregnancy test is required for women of child-bearing potential within 7 days prior to enrollment)
5. 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)
6. Subject has an allergy to imaging contrast media which cannot be adequately pre-medicated
7. 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
8. New York Heart Association (NYHA) class III or IV heart failure
9. Renal failure with serum creatinine >2.5 mg/dL or chronic dialysis
10. History of a stroke or transient ischemic attack (TIA) within 6 months, or any prior intracranial hemorrhage or permanent neurologic deficit
11. Active peptic ulcer or upper gastrointestinal (GI) bleeding within 6 months
12. Untreated pre-procedural hemoglobin <10 g/dL or intention to refuse blood transfusions if one should become necessary
13. 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)
14. Subject has a hypercoagulable disorder such as polycythemia vera, platelet count >750,000 or other disorders
15. Uncontrolled diabetes defined as a HbA1c greater than or equal to 10%
16. Subject has an active systemic infection on the day of the index procedure with either fever, leukocytosis or requiring intravenous antibiotics
17. Subjects in cardiogenic shock or with clinical evidence of left-sided heart failure (S3 gallop, pulmonary rales, oliguria, or hypoxemia)
18. Uncontrolled severe hypertension (systolic BP >180 mm Hg or diastolic BP >110 mm Hg)
19. Subjects with a life expectancy of less than 1 year
20. 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
21. 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
22. Subject refusing or not a candidate for emergency coronary artery bypass grafting (CABG) surgery
23. Planned use of atherectomy, scoring or cutting balloon, or any investigational device other than lithotripsy
24. 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
25. Unprotected left main diameter stenosis >30%
26. Target vessel is excessively tortuous defined as the presence of two or more bends >90º or three or more bends >75º
27. Definite or possible thrombus (by angiography or intravascular imaging) in the target vessel
28. Evidence of aneurysm in target vessel within 10 mm of the target lesion
29. Target lesion is an ostial location (LAD, LCX, or RCA, within 5 mm of ostium) or an unprotected left main lesion
30. Target lesion is a bifurcation with ostial diameter stenosis ≥30%
31. Second lesion with >50% stenosis in the same target vessel as the target lesion including its side branches
32. Target lesion is located in a native vessel that can only be reached by going through a saphenous vein or arterial bypass graft
33. Previous stent within the target vessel implanted within the last year
34. Previous stent within 10 mm of the target lesion regardless of the timing of its implantation
35. Angiographic evidence of a dissection in the target vessel at baseline or after guidewire passage

Contacts and Locations

Locations

United States, Arizona

Honor Health

Scottsdale, Arizona, United States, 85258

United States, California

Scripps Clinic

La Jolla, California, United States, 92037

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

La Jolla, California, United States, 92037

St. Joseph Hospital

Orange, California, United States, 92868

VA Palo Alto Health Care System

Palo Alto, California, United States, 94304

United States, Connecticut

Yale New Haven Hospital

New Haven, Connecticut, United States, 06520

United States, District of Columbia

MedStar Washington Hospital Center

Washington, District of Columbia, United States, 20010

United States, Georgia

Emory University Hospital Midtown

Atlanta, Georgia, United States, 30308

Piedmont Heart Institute

Atlanta, Georgia, United States, 30309

United States, Illinois

Northwestern University

Chicago, Illinois, United States, 60611

Advocate Health and Hospitals Corporation - Edward Hospital

Oakbrook Terrace, Illinois, United States, 60540

United States, Indiana

St. Vincent Heart Center of Indiana, LLC

Indianapolis, Indiana, United States, 46290

United States, Louisiana

Ochsner Clinic Foundation

New Orleans, Louisiana, United States, 70121

United States, Maryland

MedStar Union Memorial Hospital

Baltimore, Maryland, United States, 21218

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

United States, Michigan

Henry Ford Hospital

Detroit, Michigan, United States, 48202

United States, Minnesota

Minneapolis Heart Institute

Minneapolis, Minnesota, United States, 55407

United States, Mississippi

North Mississippi Medical Center

Tupelo, Mississippi, United States, 38801

United States, Missouri

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, United States, 64111

United States, New Jersey

Deborah Heart and Lung Center

Browns Mills, New Jersey, United States, 08015

United States, New York

Montefiore Medical Center

Bronx, New York, United States, 10467

New York University (NYU) Langone Medical Center

New York, New York, United States, 10016

Columbia University Medical Center/ New York Presbyterian

New York, New York, United States, 10065

St. Francis Hospital

Roslyn, New York, United States, 11576

United States, North Carolina

Durham VA Health Care System

Durham, North Carolina, United States, 27705

NC Heart and Vascular

Raleigh, North Carolina, United States, 27607

United States, Ohio

The Christ Hospital

Cincinnati, Ohio, United States, 45219

United States, Pennsylvania

Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, United States, 19096

Geisinger Medical Center

Danville, Pennsylvania, United States, 17822

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States, 15213

Pinnacle Health Cardiovascular Institute Inc.

Wormleysburg, Pennsylvania, United States, 17043

United States, Rhode Island

The Miriam Hospital

Providence, Rhode Island, United States, 02906

United States, Texas

Baylor Heart and Vascular Hospital

Dallas, Texas, United States, 75226

Houston Methodist Hospital

Houston, Texas, United States, 77030

United States, Vermont

University of Vermont

Burlington, Vermont, United States, 05401

United States, Washington

University of Washington Medical Center

Seattle, Washington, United States, 98195

United States, West Virginia

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

Charleston, West Virginia, United States, 25304

France

Clinique Pasteur

Toulouse, Cedex 3, France, 31076

Clinique des Domes - Pole Sante Republique

Clermont-Ferrand, France, 63050

Institute Cardiovasculaire Paris Sud

Massy, France, 91300

Germany

Universitaetsklinikum Giessen and Marburg GmbH

Marburg, CET, Germany

Charité - Universitaetsmedizin Berlin

Berlin, Germany, 12203

Rheinland Klinikum Neuss GmbH - Lukaskrankenhaus Neuss

Neuss, Germany, 41464

United Kingdom

Golden Jubilee National Hospital

Clydebank, United Kingdom, G81 4DY

St. Bartholomew's Hospital

London, United Kingdom, EC1A 7BE

King's College Hospital

London, United Kingdom, SE5 9RS

Sponsors and Collaborators

Shockwave Medical, Inc.

Investigators

• Study Chair: Dean J Kereiakes, MD,FACC,FSCAI; The Christ Hospital Heart and Vascular Center and The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital
• Study Chair: Gregg W Stone, MD,FACC,FSCAI; Columbia University
• Study Chair: Jonathan Hill, MD; Royal Brompton and Harefield NHS Foundation Trust

  Study Documents (Full-Text)

Documents provided by Shockwave Medical, Inc.:

Study Protocol and Statistical Analysis Plan  [PDF] March 5, 2021

More Information

Additional Information:

Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Lesions: 1-Year Results From the Disrupt CAD III Study 

Publications of Results:

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Shockwave Medical, Inc.
• ClinicalTrials.gov Identifier: NCT03595176
• Other Study ID Numbers: CP 61982
• First Posted: July 23, 2018
• Results First Posted: June 21, 2021
• Last Update Posted: June 21, 2022
• Last Verified: May 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Shockwave Medical, Inc.:

Intravascular Lithotripsy; Percutaneous Coronary Intervention

Additional relevant MeSH terms:

Coronary Artery Disease; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Necrosis; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases