FORWARD CAD IDE Study

NCT06662500 | Recruiting FDA Device

• 1 other identifier: CP 71886
• Study Type: interventional
• Target: 408
• Locations: 2 countries
• Sites: 34

Brief Summary

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.

Conditions

Coronary Arterial Disease (CAD)

Keywords

Intravascular Lithotripsy

Outcome Measures

Primary Outcomes (2)

• Primary Safety Endpoint - Freedom from MACE within 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

• Primary Performance Endpoint - Technical Success

  Technical Success defined as successful Shockwave Javelin Coronary IVL-enabled lesion crossing without serious angiographic complications determined by angiographic core lab

  Peri-procedural

Study Arms (1)

Shockwave Javelin Coronary IVL Catheter

EXPERIMENTAL

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

Interventions

Intravascular Lithotripsy DEVICE

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.

Shockwave Javelin Coronary IVL Catheter

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
• Subject is able and willing to comply with all assessments in the study.
• Subjects with native coronary artery disease including stable angina or following stabilization after acute coronary syndromes (ACS) for non-emergent percutaneous coronary intervention (PCI)
• Biomarkers (troponin) must be:
• 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
• 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.
• 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).
• Subject, or legally authorized representative, signs a written Informed Consent form to participate in the study, prior to any study-mandated procedures.
• Estimated life expectancy \>1 year.
• 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 no evidence of elevated biomarkers post-procedure; OR
• \>30 days after the study procedure
• The target lesion must be a de novo coronary lesion that has not been previously treated successfully with any interventional procedure
• Single de novo target lesion stenosis of protected LMCA, or LAD, RCA or LCX (or of their branches)

You may not qualify if:

• Any comorbidity or condition which may prevent compliance with this protocol, including follow-up visits
• Subject is participating in another research study involving an investigational agent including 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 STEMI within 30 days prior to index procedure
• 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 institutional 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 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 (34)

Scripps Health

La Jolla, California, 92037, United States

RECRUITING

University of California, San Francisco

San Francisco, California, 94143, United States

ACTIVE NOT RECRUITING

South Denver Cardiology Associates, P.C

Littleton, Colorado, 80120, United States

RECRUITING

Hartford Hospital

Hartford, Connecticut, 06112, United States

RECRUITING

Medstar Washington Hospital Center

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

RECRUITING

The Cardiac and Vascular Institute

Gainesville, Florida, 32605, United States

RECRUITING

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

RECRUITING

Emory University Hospital

Atlanta, Georgia, 30322, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

ACTIVE NOT RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Minneapolis Heart Institute

Minneapolis, Minnesota, 55407, United States

RECRUITING

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

Columbia University Medical Center/New York Presbyterian Hospital

New York, New York, 10032, United States

RECRUITING

Lenox Hill Hospital

New York, New York, 10075, United States

RECRUITING

St. Francis Hospital & Heart Center

Roslyn, New York, 11576, United States

RECRUITING

NC Heart and Vascular Research, LLC

Raleigh, North Carolina, 27607, United States

RECRUITING

The Christ Hospital

Cincinnati, Ohio, 45219, United States

RECRUITING

Providence St. Vincent

Portland, Oregon, 97225, United States

RECRUITING

Wellspan York Hospital

York, Pennsylvania, 17403, United States

RECRUITING

Centennial Heart

Nashville, Tennessee, 37203, United States

ACTIVE NOT RECRUITING

Baylor Scott & White Research Institute Dallas

Dallas, Texas, 75226, United States

RECRUITING

Houston Methodist Hospital

Houston, Texas, 77030, United States

RECRUITING

Baylor Scott and White - The Heart Hospital Baylor Plano

Plano, Texas, 75093, United States

RECRUITING

Intermountain Medical Center Heart Institute

Salt Lake City, Utah, 84111, United States

RECRUITING

Overlake Medical Center

Bellevue, Washington, 98004, United States

RECRUITING

Swedish Medical

Seattle, Washington, 98122, United States

RECRUITING

University of Washington Medical Center

Seattle, Washington, 98195, United States

RECRUITING

Basildon University Hospital

Basildon, UK, SS16 5NL, United Kingdom

RECRUITING

Bristol Heart Institute

Bristol, UK, BS2 8ED, United Kingdom

RECRUITING

Leeds Teaching Hospital NHS Trust

Leeds, UK, LS1 3EX, United Kingdom

RECRUITING

Glenfield Hospital

Leicester, UK, LE3 9QP, United Kingdom

RECRUITING

St. Thomas Hospital

London, UK, SE1 7EH, United Kingdom

RECRUITING

St. George's Hospital

London, UK, SW17 0RE, United Kingdom

RECRUITING

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Randee Randoll

CONTACT

408-577-7856; RRandoll@its.jnj.com

Lesli DeSimone

CONTACT

916-261-5189; LDeSimon@its.jnj.com

Study Design

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

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: October 29, 2024
• Study Start: April 4, 2025
• Primary Completion: December 8, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-02

Locations

US (28); GB (6)