FORWARD CAD IDE Study

Part of paid clinical trials in La Jolla, California.

Sponsor
Shockwave Medical, Inc.
Study ID
NCT06662500
Status
Recruiting
Apply to this trial

Conditions

  • Coronary Arterial Disease (CAD)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Apr 4, 2025
Status verified
Feb 2026
Primary completion
Dec 8, 2025
Completion
Dec 31, 2027

Study Design

Enrollment
408 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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).

Primary Outcome Measure

Primary Safety Endpoint - Freedom from MACE within 30 days [ Time Frame: 30 Days ]

Central Contacts

Locations (28)

FacilityCityStateZIPSite coordinators
Scripps HealthLa JollaCalifornia92037
Brendan Neilan
[email protected]
858-824-5249
Matthew Price, M.D. (PRINCIPAL_INVESTIGATOR)
University of California, San FranciscoSan FranciscoCalifornia94143
Kaye Reambonanza
[email protected]
415-514-6147
Yousif Ahmad, PhD (PRINCIPAL_INVESTIGATOR)
South Denver Cardiology Associates, P.CLittletonColorado80120
Rachel Kim
[email protected]
303-703-2053
Cinthia Bateman, MD (PRINCIPAL_INVESTIGATOR)
Hartford HospitalHartfordConnecticut06112
Marianne McCarthy
[email protected]
860-972-1788
Saurabh Joshi, MD (PRINCIPAL_INVESTIGATOR)
Medstar Washington Hospital CenterWashington D.C.District of Columbia20010
Michelle Singh
[email protected]
202-877-2190
Ron Waksman, MD (PRINCIPAL_INVESTIGATOR)
The Cardiac and Vascular InstituteGainesvilleFlorida32605
Marti Roberson
[email protected]
352-244-0208
Matheen Khuddus, MD (PRINCIPAL_INVESTIGATOR)
Emory University HospitalAtlantaGeorgia30322
Farhad Jameel
[email protected]
404-712-7665
William Nicholson, MD (PRINCIPAL_INVESTIGATOR)
Piedmont Heart InstituteAtlantaGeorgia30309
Suzanne Corley
[email protected]
404-605-3118
Prashant Kaul, MD (PRINCIPAL_INVESTIGATOR)
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Jenifer Kaufman
[email protected]
617-632-8956
Hector Tamez, MD (PRINCIPAL_INVESTIGATOR)
Brigham and Women's HospitalBostonMassachusetts02115
Barbora Zvarova
[email protected]
617-525-5028
Kevin Croce, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114
Sidney Searles
[email protected]
401-601-8007
Suzanne Baron, MD (PRINCIPAL_INVESTIGATOR)
Minneapolis Heart InstituteMinneapolisMinnesota55407
Opeyemi Akindumila
[email protected]
612-863-3900
Emmanouil Brilakis, MD (PRINCIPAL_INVESTIGATOR)
Columbia University Medical Center/New York Presbyterian HospitalNew YorkNew York10032
Kate Dalton, MS, RD, CCRC
[email protected]
347-514-3366
Margaret McEntegart, M.D. (PRINCIPAL_INVESTIGATOR)
Lenox Hill HospitalNew YorkNew York10075
Sara Velichkovikj
[email protected]
212-434-3802
Michael Kim, MD (PRINCIPAL_INVESTIGATOR)
NYU Langone HealthNew YorkNew York10016
Natalie Massenburg
[email protected]
646-634-6178
Claudia Serrano-Gomez, M.D. (PRINCIPAL_INVESTIGATOR)
St. Francis Hospital & Heart CenterRoslynNew York11576
Elizabeth Haag
[email protected]
516-562-6790
Ziad Ali, M.D. (PRINCIPAL_INVESTIGATOR)
NC Heart and Vascular Research, LLCRaleighNorth Carolina27607
James Pierre-Louis
[email protected]
919-784-8695
James Zidar, MD (PRINCIPAL_INVESTIGATOR)
The Christ HospitalCincinnatiOhio45219
Kiera Carlisle
[email protected]
513-585-1777
Jarrod Frizzel, MD (PRINCIPAL_INVESTIGATOR)
Providence St. VincentPortlandOregon97225
Sheryl Ames
[email protected]
503-216-2099
Jason Wollmuth, MD (PRINCIPAL_INVESTIGATOR)
Wellspan York HospitalYorkPennsylvania17403
Lori Slenker
[email protected]
717-356-5159
Rhian Davies, DO (PRINCIPAL_INVESTIGATOR)
Centennial HeartNashvilleTennessee37203-
Baylor Scott & White Research Institute DallasDallasTexas75226
Geoffrey Gong
[email protected]
214-820-3319
Robert Stoler, MD (PRINCIPAL_INVESTIGATOR)
Houston Methodist HospitalHoustonTexas77030
Padmaja Naik
[email protected]
281-615-9407
Alpesh Shah, MD (PRINCIPAL_INVESTIGATOR)
Baylor Scott and White - The Heart Hospital Baylor PlanoPlanoTexas75093
Selena Ortega
[email protected]
469-814-4738
Srinivasa Potluri, MD (PRINCIPAL_INVESTIGATOR)
Intermountain Medical Center Heart InstituteSalt Lake CityUtah84111
Michael Tomlinson
[email protected]
801-507-4833
Mitul Patel, MD (PRINCIPAL_INVESTIGATOR)
Overlake Medical CenterBellevueWashington98004
Diana Samolyuk
[email protected]
425-899-5419
Robert Riley, MD (PRINCIPAL_INVESTIGATOR)
Swedish MedicalSeattleWashington98122
Tina Pratt
[email protected]
206-320-3919
Christopher Brown, MD (PRINCIPAL_INVESTIGATOR)
University of Washington Medical CenterSeattleWashington98195
John Tushinski
[email protected]
206-685-4346
Lorenzo Azzalini, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in La Jolla, CA

By research site
Scripps Health· La Jolla, CAUniversity of California, San Francisco· San Francisco, CASouth Denver Cardiology Associates, P.C· Littleton, COHartford Hospital· Hartford, CTMedstar Washington Hospital Center· Washington D.C., DCThe Cardiac and Vascular Institute· Gainesville, FL

Related Studies