Shockwave C2+ 2Hz Coronary IVL Catheter in Calcified Coronary Arteries (Disrupt CAD DUO)

NCT05966662 | Completed Results DMC FDA Device

• 1 other identifier: CP 68277
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 18

Brief Summary

This investigational device exemption (IDE) study is to assess the safety and effectiveness of the Shockwave Coronary Intravascular Lithotripsy (IVL) System with the Shockwave C2+ 2Hz Coronary IVL Catheter to treat de novo, calcified, stenotic, coronary lesions prior to stenting.

Conditions

Coronary Artery Disease; Myocardial Infarction

Keywords

Intravasular Lithotripsy; PCI

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Who Experienced Freedom From Major Adverse Cardiac Events (MACE) Within 30 Days Post-procedure

  Freedom from MACE within 30 days of the index procedure. MACE is defined as a composite occurrence of: cardiac death, myocardial infarction (MI), target vessel revascularization (TVR) after the completion of the index procedure.

  within 30 days of index procedure

• Percentage of Participants With Procedural Success (Residual Stenosis ≤30%)

  Procedural Success post stent delivery with a residual stenosis ≤30% (core laboratory assessed) and without in-hospital MACE.

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

Secondary Outcomes (19)

• Number of Participants With Device Crossing Success

  at the end of procedure

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

  at the end of procedure

• Number of Participants With Procedural Success (Residual Stenosis <50% and Without In-hospital MACE)

  at the end of the procedure

• Number of Participants With Angiographic Success (Residual Stenosis ≤30%)

  at end of procedure

• Number of Participants With Serious Angiographic Complications

  at end of procedure

Study Arms (1)

Single-Arm

EXPERIMENTAL

Subjects with de novo, calcified coronary artery lesions presenting with stable, unstable, or silent ischemia that are suitable for percutaneous coronary intervention (PCI).

Device: IVL with Shockwave C2+ 2Hz Coronary IVL Catheter

Interventions

IVL with Shockwave C2+ 2Hz Coronary IVL Catheter DEVICE

Lithotripsy-enabled, low-pressure balloon dilatation of severely calcified, stenotic de novo coronary arteries prior to stenting.

Single-Arm

Eligibility Criteria

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

You may qualify if:

• Subject is ≥18 years of age
• Subjects with native coronary artery disease (including stable or unstable angina and silent ischemia) suitable for PCI
• For subjects with unstable ischemic heart disease, biomarkers (CK-MB and troponin) must be less than or equal to the upper limit of the laboratory normal within 12 hours prior to the procedure (note: both must be normal)
• For subjects 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 (CK-MB and troponin) must be less than or equal to the upper limit of the laboratory normal within 12 hours of the procedure (note: both must be normal)
• If 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
• 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 criterion; 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
• Non-target lesions 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
• 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

You may not qualify if:

• Any comorbidity or condition which may reduce compliance with this protocol, including follow-up visits
• 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 antiplatelet/anticoagulation therapy per society guidelines
• Subject has an allergy to imaging contrast media which cannot be adequately pre-medicated
• 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 greater than 1 times the local laboratory's upper limit of normal
• New York Heart Association (NYHA) class III or IV heart failure
• Subject has acute or chronic renal disease with eGFR \<30 ml/min/1.73m2 (using CKD-EPI formula)
• History of a stroke or transient ischemic attack (TIA) within 60 days, or any prior intracranial hemorrhage or permanent neurologic deficit
• Active peptic ulcer or upper gastrointestinal (GI) bleeding within 3 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 related blood disorders
• Subject has an active systemic infection on the day of the index procedure with either fever, leukocytosis or requiring intravenous antibiotics
• Subjects with clinical evidence of cardiogenic shock

Sponsors & Collaborators

• Shockwave Medical, Inc.: lead

Study Sites (18)

Heart Center Research

Huntsville, Alabama, 35801, United States

Location

Scripps Clinic

La Jolla, California, 92121, United States

Location

Medstar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Memorial Health

Hollywood, Florida, 33021, United States

Location

Wellstar Kennestone Hospital

Marietta, Georgia, 30060, United States

Location

Loyola University

Chicago, Illinois, 60153, United States

Location

Norton Heart and Vascular Institute

Louisville, Kentucky, 40205, United States

Location

Essentia Health St. Mary's Heart & Vascular Center

Duluth, Minnesota, 55805, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Northwell Health/Lenox Hill

New York, New York, 11030, United States

Location

St. Francis Hospital

Roslyn, New York, 11576, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

UPMC Pinnacle Health

Harrisburg, Pennsylvania, 17110, United States

Location

WellSpan Health - York

York, Pennsylvania, 17403, United States

Location

Baylor Scott and White Research Institute

Dallas, Texas, 75226, United States

Location

Methodist Hospital

San Antonio, Texas, 78229, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

Charleston Area Medical Center

Charleston, West Virginia, 25304, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Infarction

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Results Point of Contact

• Title: Tracy Courtney
• Organization: Shockwave Medical

TCourtn4@its.jnj.com

1.650.224.7699

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Shockwave C2+ 2Hz Coronary IVL Catheter with Shockwave Intravascular Lithotripsy (IVL) System

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: August 1, 2023
• Study Start: December 8, 2023
• Primary Completion: January 9, 2025
• Study Completion: December 19, 2025
• Last Updated: February 24, 2026
• Results First Posted: January 28, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (18)