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

February 3, 2026 updated by: Shockwave Medical, Inc.

Prospective, Multicenter, Single-Arm IDE Study of the Shockwave Coronary Intravascular Lithotripsy (IVL) System With the Shockwave C2+ 2Hz Coronary IVL Catheter in Calcified Coronary Arteries (Disrupt CAD Duo Study)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The Shockwave Coronary Intravascular Lithotripsy (IVL) System with the Shockwave C2+ 2Hz Coronary IVL Catheter is indicated for lithotripsy-enabled, low-pressure balloon dilatation of severely calcified, stenotic de novo coronary arteries prior to stenting.

Up to 145 subjects (138 evaluable) subjects with de novo, calcified coronary artery lesions presenting with stable, unstable, or silent ischemia that are suitable for percutaneous coronary intervention (PCI) will be enrolled at up to 20 US sites.

Enrollment duration will be approximately 10-12 months and study duration will be approximately 2 years.

Each subject will be followed through discharge, 30 days, 6, and 12 months.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
145

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Heart Center Research
    • California
      • La Jolla, California, United States, 92121
        • Scripps Clinic
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • MedStar Washington Hospital Center
    • Florida
      • Hollywood, Florida, United States, 33021
        • Memorial Health
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Wellstar Kennestone Hospital
    • Illinois
      • Chicago, Illinois, United States, 60153
        • Loyola University
    • Kentucky
      • Louisville, Kentucky, United States, 40205
        • Norton Heart and Vascular Institute
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • Essentia Health St. Mary's Heart & Vascular Center
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University
    • New York
      • New York, New York, United States, 11030
        • Northwell Health/Lenox Hill
      • Roslyn, New York, United States, 11576
        • St. Francis Hospital
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • The Christ Hospital
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17110
        • UPMC Pinnacle Health
      • York, Pennsylvania, United States, 17403
        • WellSpan Health - York
    • Texas
      • Dallas, Texas, United States, 75226
        • Baylor Scott and White Research Institute
      • San Antonio, Texas, United States, 78229
        • Methodist Hospital
    • Washington
      • Seattle, Washington, United States, 98122
        • Swedish Medical Center
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • Charleston Area Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:Subjects are required to meet all of the following inclusion criteria in order to be enrolled in the clinical study.

General 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 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)

  4. 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

    1. 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)
    2. 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
  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 criterion; 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. Non-target lesions 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: Subjects who meet any of the following exclusion criteria may not be enrolled in the study:

General Exclusion Criteria

  1. Any comorbidity or condition which may reduce compliance with this protocol, including follow-up visits
  2. Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint
  3. Subject is pregnant or nursing (a negative pregnancy test is required for women of child-bearing potential within 7 days prior to enrollment)
  4. Unable to tolerate antiplatelet/anticoagulation therapy per society guidelines
  5. Subject has an allergy to imaging contrast media which cannot be adequately pre-medicated
  6. 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
  7. New York Heart Association (NYHA) class III or IV heart failure
  8. Subject has acute or chronic renal disease with eGFR <30 ml/min/1.73m2 (using CKD-EPI formula)
  9. History of a stroke or transient ischemic attack (TIA) within 60 days, or any prior intracranial hemorrhage or permanent neurologic deficit
  10. Active peptic ulcer or upper gastrointestinal (GI) bleeding within 3 months
  11. Untreated pre-procedural hemoglobin <10 g/dL or intention to refuse blood transfusions if one should become necessary
  12. 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)
  13. Subject has a hypercoagulable disorder such as polycythemia vera, platelet count >750,000 or other related blood disorders
  14. Subject has an active systemic infection on the day of the index procedure with either fever, leukocytosis or requiring intravenous antibiotics
  15. Subjects with clinical evidence of cardiogenic shock
  16. Uncontrolled severe hypertension (systolic BP >180 mm Hg or diastolic BP >110 mm Hg)
  17. Subjects with a life expectancy of less than 1 year
  18. 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
  19. 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
  20. Subject refusing or not a candidate for emergency coronary artery bypass grafting (CABG) surgery

  21. Planned use of atherectomy, scoring or cutting balloon, or any investigational device other than lithotripsy

    Angiographic Exclusion Criteria

  22. Unprotected left main diameter stenosis >30%
  23. Definite or possible thrombus (by angiography or intravascular imaging) in the target vessel
  24. Evidence of aneurysm in target vessel within 10 mm of the target lesion
  25. Target lesion is located in a native vessel that can only be reached by going through a saphenous vein or arterial bypass graft
  26. Previous stent within 5 mm of the target lesion regardless of the timing of its implantation
  27. Angiographic evidence of a dissection or perforation in the target vessel at baseline or after guidewire passage

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Single-Arm
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
Lithotripsy-enabled, low-pressure balloon dilatation of severely calcified, stenotic de novo coronary arteries prior to stenting.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Experienced Freedom From Major Adverse Cardiac Events (MACE) Within 30 Days Post-procedure
Time Frame: within 30 days of index 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%)
Time Frame: 12-24 hours post procedure or at discharge, whichever is earlier, but at least 6 hours post procedure
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Angiographic Success (Residual Stenosis <50%)
Time Frame: at the end of procedure
Angiographic Success defined as stent delivery with <50% residual stenosis and without serious angiographic complications.
at the end of procedure
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.
at end of procedure
Number of Participants With Device Crossing Success
Time Frame: at the end of procedure
Device Crossing Success is defined as the ability to deliver the IVL catheter across the target lesion, and delivery of lithotripsy without serious angiographic complications immediately after IVL.
at the end of procedure
Number of Participants With Procedural Success (Residual Stenosis <50% and Without In-hospital MACE)
Time Frame: at the end of the procedure
Procedural Success defined as stent delivery with a residual stenosis <50% (core laboratory assessed) and without in-hospital MACE.
at the end of the procedure
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.
at end of procedure
Target Lesion Failure 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.
within 30 days of index procedure
All-Cause Death Rate at 30 Days
Time Frame: within 30 days of index procedure
Percentage of participants who experienced death (all-cause) through 30 days post index procedure.
within 30 days of index procedure
Cardiac Death Rate at 30 Days
Time Frame: within 30 days of index procedure
Percentage of participants who experienced cardiac death through 30 days post index procedure
within 30 days of index procedure
MI Rate at 30 Days
Time Frame: within 30 days of index procedure
Percentage of participants who experienced myocardial infarction through 30 days post index procedure
within 30 days of index procedure
Target Vessel-MI (TV-MI) Rate at 30 Days
Time Frame: within 30 days of index procedure
Percentage of participants who experienced MI attributable to the target vessel through 30 days post index procedure
within 30 days of index procedure
Procedural MI Rate at 30 Days
Time Frame: within 30 days of index procedure
Percentage of participants who experienced procedural myocardial infarction through 30 days post index procedure
within 30 days of index procedure
Non-Procedural MI Rate at 30 Days
Time Frame: within 30 days of index procedure
Percentage of participants who experienced Non-Procedural MI defined as spontaneous MI beyond discharge (4th Universal Definition) through 30 days post index procedure
within 30 days of index procedure
Ischemia Driven-Target Vessel Revascularization (ID-TVR) Rate at 30 Days
Time Frame: within 30 days of index procedure
Percentage of participants who experienced a Ischemia-Driven Target Vessel Revascularization through 30-days post index procedure
within 30 days of index procedure
Ischemia-Driven Target Lesion Revascularization (ID-TLR) Rate at 30 Days
Time Frame: within 30 days of index procedure
Percentage of participants who experienced a Ischemia-Driven Target Lesion Revascularization through 30-days post index procedure
within 30 days of index procedure
Non-Ischemia-Driven Target Vessel Revascularization (Non-ID-TVR) Rate at 30 Days
Time Frame: within 30 days of index procedure
Percentage of participants who experienced a Non-Ischemia-Driven Target Vessel Revascularization through 30-days post index procedure
within 30 days of index procedure
Non-ID-TLR Rate at 30 Days
Time Frame: within 30 days of index procedure
Percentage of participants who experienced a Non-Ischemia-Driven Target Lesion Revascularization through 30-days post index procedure
within 30 days of index procedure
Any Revascularizations Rate at 30 Days
Time Frame: within 30 days of index procedure
Percentage of participants who experienced any revascularizations (ID and non-ID) through 30 days post index procedure.
within 30 days of index procedure
Stent Thrombosis Rate at 30 Days
Time Frame: within 30 days of index procedure
Percentage of participants who experienced any stent thrombosis (definite, probable, definite or probable) through 30 days post index procedure.
within 30 days of index procedure
Rate of MI Using the 4th Universal Definition at 30 Days
Time Frame: within 30 days of index procedure
Percentage of participants who experienced MI using the 4th Universal Definition through 30 days post index procedure.
within 30 days of index procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shockwave Medical, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 8, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 9, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 19, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 20, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 1, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CP 68277

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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