RECRUITING

FORWARD CAD IDE Study

Conditions

Coronary Arterial Disease (CAD)Intravascular Lithotripsy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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)

Quick Facts

Study Start:2025-04-04

Study Completion:2027-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06662500

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 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)	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 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.

Inclusion Criteria

Exclusion 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
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)

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
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.

Contacts and Locations

Study Contact

Randee Randoll

CONTACT

408-577-7856

RRandoll@its.jnj.com

Lesli DeSimone

CONTACT

916-261-5189

LDeSimon@its.jnj.com

Principal Investigator

Robert W Yeh, M.D., M.Sc, M.B.A

PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

James C Spratt, MD, MB, ChB, FRCP, FESC, FACC

PRINCIPAL_INVESTIGATOR

St. George's University NHS Trust

Robert F Riley, MD, MS, FACC, FAHA, FSCAI

PRINCIPAL_INVESTIGATOR

Overlake Medical Center & Clinics

Study Locations (Sites)

Scripps Health

La Jolla, California, 92037

United States

University of California, San Francisco

San Francisco, California, 94143

United States

South Denver Cardiology Associates, P.C

Littleton, Colorado, 80120

United States

Hartford Hospital

Hartford, Connecticut, 06112

United States

Medstar Washington Hospital Center

Washington D.C., District of Columbia, 20010

United States

The Cardiac and Vascular Institute

Gainesville, Florida, 32605

United States

Piedmont Heart Institute

Atlanta, Georgia, 30309

United States

Emory University Hospital

Atlanta, Georgia, 30322

United States

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Brigham and Women's Hospital

Boston, Massachusetts, 02115

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

United States

Minneapolis Heart Institute

Minneapolis, Minnesota, 55407

United States

NYU Langone Health

New York, New York, 10016

United States

Columbia University Medical Center/New York Presbyterian Hospital

New York, New York, 10032

United States

Lenox Hill Hospital

New York, New York, 10075

United States

St. Francis Hospital & Heart Center

Roslyn, New York, 11576

United States

NC Heart and Vascular Research, LLC

Raleigh, North Carolina, 27607

United States

The Christ Hospital

Cincinnati, Ohio, 45219

United States

Providence St. Vincent

Portland, Oregon, 97225

United States

Wellspan York Hospital

York, Pennsylvania, 17403

United States

Centennial Heart

Nashville, Tennessee, 37203

United States

Baylor Scott & White Research Institute Dallas

Dallas, Texas, 75226

United States

Houston Methodist Hospital

Houston, Texas, 77030

United States

Baylor Scott and White - The Heart Hospital Baylor Plano

Plano, Texas, 75093

United States

Intermountain Medical Center Heart Institute

Salt Lake City, Utah, 84111

United States

Overlake Medical Center

Bellevue, Washington, 98004

United States

Swedish Medical

Seattle, Washington, 98122

United States

University of Washington Medical Center

Seattle, Washington, 98195

United States

Collaborators and Investigators

Sponsor: Shockwave Medical, Inc.

Robert W Yeh, M.D., M.Sc, M.B.A, PRINCIPAL_INVESTIGATOR, Beth Israel Deaconess Medical Center
James C Spratt, MD, MB, ChB, FRCP, FESC, FACC, PRINCIPAL_INVESTIGATOR, St. George's University NHS Trust
Robert F Riley, MD, MS, FACC, FAHA, FSCAI, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2025-04-04

Study Completion Date2027-12

Study Record Updates

Study Start Date2025-04-04

Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

Intravascular Lithotripsy

Additional Relevant MeSH Terms

Coronary Arterial Disease (CAD)