FORWARD CAD IDE Study

June 1, 2026 updated by: Shockwave Medical, Inc.

Prospective, Multicenter, Single-Arm, Investigational Device Exemption (IDE) Study of the Shockwave Intravascular Lithotripsy (IVL) System With the Shockwave Javelin Coronary IVL Catheter (FORWARD CAD IDE Study)

The FORWARD CAD IDE Study is a Prospective, Multicenter, Single-Arm, Investigational Device Exemption (IDE) Study conducted to assess the safety and effectiveness of the Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Coronary IVL Catheter for the treatment of calcified, stenotic de novo coronary artery lesions prior to stenting.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The Shockwave Javelin Coronary IVL Catheter was developed to address the current challenges clinicians face when treating tight, difficult to cross, calcified coronary lesions and was designed as a rapid exchange catheter to deliver intravascular lithotripsy to those complex lesions in the coronary vasculature.

The intended benefit of the Shockwave Javelin Coronary IVL Catheter is to allow the catheter to modify calcium in tight, difficult to cross lesions to increase the compliance of the vessel and allow further crossing of the device or additional treatment at the discretion of the physician.

Up to 158 subjects (150 evaluable) subjects with moderate-to severely calcified, stenotic de novo coronary artery lesions presenting with stable angina or following stabilization after acute coronary syndrome (ACS) that are suitable for non-emergent percutaneous coronary intervention (PCI) will be enrolled at up to 35 sites.

Once the pivotal cohort is fully enrolled (N=158), the study will continue to enroll an Extended Investigation cohort of up to 250 additional subjects.

Study Type

Interventional

Enrollment (Estimated)

408

Phase

  • 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 Backup

Study Locations

  • United Kingdom
    • UK
      • Basildon, UK, United Kingdom, SS16 5NL
        • Recruiting
        • Basildon University Hospital
        • Contact:
        • Principal Investigator:
          • John Davies, PhD
      • Bristol, UK, United Kingdom, BS2 8ED
        • Recruiting
        • Bristol Heart Institute
        • Contact:
        • Principal Investigator:
          • Julian Strange, MD
      • Leeds, UK, United Kingdom, LS1 3EX
        • Recruiting
        • Leeds Teaching Hospital NHS Trust
        • Contact:
        • Principal Investigator:
          • Abdul Mozid, MD
      • Leicester, UK, United Kingdom, LE3 9QP
        • Recruiting
        • Glenfield Hospital
        • Principal Investigator:
          • Andrew Ladwiniec, MD
        • Contact:
      • London, UK, United Kingdom, SW17 0RE
        • Recruiting
        • St. George's Hospital
        • Principal Investigator:
          • James Spratt, MD
        • Contact:
      • London, UK, United Kingdom, SE1 7EH
        • Recruiting
        • St. Thomas Hospital
        • Contact:
        • Principal Investigator:
          • Kalpa De Silva, PhD
  • United States
    • California
      • La Jolla, California, United States, 92037
        • Recruiting
        • Scripps Health
        • Contact:
        • Principal Investigator:
          • Matthew Price, M.D.
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California, San Francisco
        • Contact:
        • Principal Investigator:
          • Yousif Ahmad, PhD
    • Colorado
      • Littleton, Colorado, United States, 80120
        • Recruiting
        • South Denver Cardiology Associates, P.C
        • Principal Investigator:
          • Cinthia Bateman, MD
        • Contact:
    • Connecticut
      • Hartford, Connecticut, United States, 06112
        • Recruiting
        • Hartford Hospital
        • Contact:
        • Principal Investigator:
          • Saurabh Joshi, MD
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Recruiting
        • Medstar Washington Hospital Center
        • Principal Investigator:
          • Ron Waksman, MD
        • Contact:
    • Florida
      • Gainesville, Florida, United States, 32605
        • Recruiting
        • The Cardiac and Vascular Institute
        • Principal Investigator:
          • Matheen Khuddus, MD
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University Hospital
        • Principal Investigator:
          • William Nicholson, MD
        • Contact:
      • Atlanta, Georgia, United States, 30309
        • Recruiting
        • Piedmont Heart Institute
        • Contact:
        • Principal Investigator:
          • Prashant Kaul, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham and Women's Hospital
        • Principal Investigator:
          • Kevin Croce, MD
        • Contact:
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
        • Principal Investigator:
          • Suzanne Baron, MD
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess Medical Center
        • Contact:
        • Principal Investigator:
          • Hector Tamez, MD
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • Minneapolis Heart Institute
        • Principal Investigator:
          • Emmanouil Brilakis, MD
        • Contact:
    • New York
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Health
        • Contact:
        • Principal Investigator:
          • Claudia Serrano-Gomez, M.D.
      • New York, New York, United States, 10075
        • Recruiting
        • Lenox Hill Hospital
        • Contact:
        • Principal Investigator:
          • Michael Kim, MD
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Medical Center/New York Presbyterian Hospital
        • Contact:
        • Principal Investigator:
          • Margaret McEntegart, M.D.
      • Roslyn, New York, United States, 11576
        • Recruiting
        • St. Francis Hospital & Heart Center
        • Contact:
        • Principal Investigator:
          • Ziad Ali, M.D.
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • Recruiting
        • NC Heart and Vascular Research, LLC
        • Principal Investigator:
          • James Zidar, MD
        • Contact:
    • Ohio
      • Cincinnati, Ohio, United States, 45219
    • Oregon
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Providence St. Vincent
        • Principal Investigator:
          • Jason Wollmuth, MD
        • Contact:
    • Pennsylvania
      • York, Pennsylvania, United States, 17403
        • Recruiting
        • Wellspan York Hospital
        • Principal Investigator:
          • Rhian Davies, DO
        • Contact:
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Active, not recruiting
        • Centennial Heart
    • Texas
      • Dallas, Texas, United States, 75226
        • Recruiting
        • Baylor Scott & White Research Institute Dallas
        • Principal Investigator:
          • Robert Stoler, MD
        • Contact:
      • Houston, Texas, United States, 77030
        • Recruiting
        • Houston Methodist Hospital
        • Principal Investigator:
          • Alpesh Shah, MD
        • Contact:
      • Plano, Texas, United States, 75093
        • Recruiting
        • Baylor Scott and White - The Heart Hospital Baylor Plano
        • Principal Investigator:
          • Srinivasa Potluri, MD
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84111
        • Recruiting
        • Intermountain Medical Center Heart Institute
        • Principal Investigator:
          • Mitul Patel, MD
        • Contact:
    • Washington
      • Bellevue, Washington, United States, 98004
        • Recruiting
        • Overlake Medical Center
        • Principal Investigator:
          • Robert Riley, MD
        • Contact:
      • Seattle, Washington, United States, 98195
        • Recruiting
        • University of Washington Medical Center
        • Principal Investigator:
          • Lorenzo Azzalini, MD
        • Contact:
      • Seattle, Washington, United States, 98122
        • Recruiting
        • Swedish Medical
        • Principal Investigator:
          • Christopher Brown, MD
        • Contact:

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

General Inclusion Criteria:

  1. Subject is ≥18 years of age
  2. Subject is able and willing to comply with all assessments in the study.
  3. Subjects with native coronary artery disease including stable angina or following stabilization after acute coronary syndromes (ACS) for non-emergent percutaneous coronary intervention (PCI)

  4. Biomarkers (troponin) must be:

    1. less than or equal to the upper limit of lab normal within 24 hours prior to the procedure or may be drawn from the side port of the sheath at the time of index if the PCI is a non-emergent procedure and has stable angina (result will not be known prior to procedure); OR
    2. if above the upper limit of lab normal, biomarker result must be less than 5 times the upper limit of lab normal within 24 hours prior to the procedure and the following criteria must be met: • The procedure must not be emergent and the subject cannot have angina at rest.
  5. Left ventricular ejection fraction (LVEF) >30% within 6 months (note: in the case of an event (MI or Revascularization) the LVEF must be taken post-event and 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. Estimated life expectancy >1 year.

  8. 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 no evidence of elevated biomarkers post-procedure; OR
    3. >30 days after the study procedure

    Angiographic Inclusion Criteria

  9. The target lesion must be a de novo coronary lesion that has not been previously treated successfully with any interventional procedure
  10. Single de novo target lesion stenosis of protected LMCA, or LAD, RCA or LCX (or of their branches)
  11. The target vessel reference diameter must be ≥2.5 mm and ≤4.0 mm

  12. The target lesion must meet one of the following criteria:

    1. Target lesion stenosis >90% up to 40 mm in length and evidence of moderate or severe calcification at the lesion site. Moderate calcification defined as angiography with densities noted only during the cardiac cycle prior to contrast injection; severe calcification defined as angiography with fluoroscopic radio-opacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall; OR
    2. Chronic total occlusion presenting with J-CTO score of 1 with evidence of calcification and occlusion length up to 20 mm.
  13. Guidewire must be in true lumen, distal to the lesion, and not subintimal, prior to insertion of Shockwave Javelin Coronary IVL catheter (antegrade wire technique only)

General Exclusion Criteria:

  1. Any comorbidity or condition which may prevent compliance with this protocol, including follow-up visits
  2. Subject is participating in another research study involving an investigational agent including 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 STEMI within 30 days prior to index procedure
  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 institutional 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 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 an estimated 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, sub-intimal reentry device, or any investigational device other than coronary IVL

    Angiographic Exclusion Criteria

  22. Unprotected left main diameter stenosis >30%
  23. Evidence of a serious angiographic complication in the target vessel prior to treatment with coronary IVL (dissection, perforation, abrupt closure, persistent slow-flow or persistent no reflow)
  24. Definite or possible thrombus by angiography in the target vessel
  25. Evidence of aneurysm in target vessel within 10 mm of the target lesion
  26. Second lesion with >50% stenosis in the same target vessel as the target lesion including its side branches
  27. Chronic total occlusion of the target lesion, J-CTO ≥2
  28. Target lesion is located in a native vessel that can only be reached by going through a saphenous vein or arterial bypass graft
  29. Previous stent within 5 mm of the target lesion
  30. Failure to successfully cross the guidewire across the target lesion
  31. Planned use of antegrade dissection and reentry (ADR), retrograde guidewire (RW), or retrograde dissection and reentry (RDR) crossing technique at any time during the procedure.

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
Intervention / Treatment
Experimental: Shockwave Javelin Coronary IVL Catheter
The Shockwave Javelin Coronary IVL Catheter will be used to treat subjects with moderate-to-severely calcified, stenotic de novo coronary artery lesions presenting with stable angina or following stabilization after acute coronary syndrome (ACS) that are suitable for non-emergent percutaneous coronary intervention (PCI).
Device: Intravascular Lithotripsy
The Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave Javelin Coronary Catheter is intended to treat calcified stenosis, including calcified stenoses that are anticipated to exhibit resistance to balloon crossing, full dilatation or subsequent uniform coronary stent expansion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Performance Endpoint - Technical Success
Time Frame: Peri-procedural
Technical Success defined as successful Shockwave Javelin Coronary IVL-enabled lesion crossing without serious angiographic complications determined by angiographic core lab
Peri-procedural
Primary Safety Endpoint - Freedom from MACE within 30 days
Time Frame: 30 Days

Freedom from major adverse cardiac events (MACE) within 30 days of the index procedure. MACE (Clinical Events Committee [CEC] adjudicated) is defined as:

  • Cardiac death; or
  • Myocardial infarction (MI) defined as CK-MB level > 3 times the upper limit of lab normal (ULN) value with or without new pathologic Q wave at discharge (periprocedural MI) and using the Fourth Universal Definition of Myocardial Infarction beyond discharge (spontaneous MI); or
  • Target vessel revascularization (TVR) defined as revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure
30 Days

Collaborators and Investigators

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

Sponsor

Shockwave Medical, Inc.

Investigators

  • Principal Investigator: Robert W Yeh, M.D., M.Sc, M.B.A, Beth Israel Deaconess Medical Center
  • Principal Investigator: James C Spratt, MD, MB, ChB, FRCP, FESC, FACC, St. George's University NHS Trust
  • Principal Investigator: Robert F Riley, MD, MS, FACC, FAHA, FSCAI, Overlake Medical Center & Clinics

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)

April 4, 2025

Primary Completion (Actual)

December 8, 2025

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

October 25, 2024

First Submitted That Met QC Criteria

October 25, 2024

First Posted (Actual)

October 29, 2024

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CP 71886

Drug and device information, study documents

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.

No

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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