Actively Recruiting
FORWARD CAD IDE Study
Led by Shockwave Medical, Inc. · Updated on 2026-05-04
408
Participants Needed
34
Research Sites
138 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
FORWARD CAD IDE Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject is 18 years of age or older
- Able and willing to comply with all study assessments
- Have native coronary artery disease with stable angina or stabilized after acute coronary syndromes for non-emergent PCI
- Troponin biomarkers within limits: either normal within 24 hours before procedure or less than 5 times normal without rest angina
- Left ventricular ejection fraction greater than 30% within 6 months
- Signed informed consent prior to study procedures
- Estimated life expectancy greater than 1 year
- Treatment of lesions in non-target vessels allowed under specified timing conditions
- Target lesion is a de novo coronary lesion not previously treated
- Single de novo target lesion stenosis in protected left main or main coronary vessels or branches
- Target vessel diameter between 2.5 mm and 4.0 mm
- Target lesion with severe or moderate calcification and stenosis over 90% or chronic total occlusion with calcification and limited length
- Guidewire in true lumen distal to lesion before catheter insertion
You will not qualify if you...
- Any condition preventing compliance with the protocol including follow-up
- Participation in another investigational study not completed
- Pregnant or nursing women
- Unable to tolerate antiplatelet or anticoagulation therapy
- Allergy to imaging contrast media not manageable with pre-medication
- Acute STEMI within 30 days prior to procedure
- New York Heart Association class III or IV heart failure
- Acute or chronic kidney disease with very low kidney function
- Recent stroke or serious neurologic damage
- Active peptic ulcer or gastrointestinal bleeding within 3 months
- Low hemoglobin or refusal of blood transfusions
- Blood clotting disorders
- Active infection with fever or requiring IV antibiotics on procedure day
- Clinical cardiogenic shock
- Uncontrolled severe high blood pressure
- Life expectancy less than 1 year
- Recent or planned non-coronary heart procedures within 30 days
- Not candidate for emergency coronary artery bypass surgery
- Planned use of certain other devices or techniques instead of coronary IVL
- Significant angiographic complications or thrombus in target vessel
- Aneurysm near target lesion
- Multiple lesions or chronic total occlusion with high complexity
- Lesion location only accessible by bypass graft
- Recent stent near target lesion
- Failure to cross lesion with guidewire
- Planned use of certain advanced crossing techniques during procedure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 34 locations
1
Scripps Health
La Jolla, California, United States, 92037
Actively Recruiting
2
University of California, San Francisco
San Francisco, California, United States, 94143
Active, Not Recruiting
3
South Denver Cardiology Associates, P.C
Littleton, Colorado, United States, 80120
Actively Recruiting
4
Hartford Hospital
Hartford, Connecticut, United States, 06112
Actively Recruiting
5
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
6
The Cardiac and Vascular Institute
Gainesville, Florida, United States, 32605
Actively Recruiting
7
Piedmont Heart Institute
Atlanta, Georgia, United States, 30309
Actively Recruiting
8
Emory University Hospital
Atlanta, Georgia, United States, 30322
Actively Recruiting
9
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
10
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Active, Not Recruiting
11
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
12
Minneapolis Heart Institute
Minneapolis, Minnesota, United States, 55407
Actively Recruiting
13
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
14
Columbia University Medical Center/New York Presbyterian Hospital
New York, New York, United States, 10032
Actively Recruiting
15
Lenox Hill Hospital
New York, New York, United States, 10075
Actively Recruiting
16
St. Francis Hospital & Heart Center
Roslyn, New York, United States, 11576
Actively Recruiting
17
NC Heart and Vascular Research, LLC
Raleigh, North Carolina, United States, 27607
Actively Recruiting
18
The Christ Hospital
Cincinnati, Ohio, United States, 45219
Actively Recruiting
19
Providence St. Vincent
Portland, Oregon, United States, 97225
Actively Recruiting
20
Wellspan York Hospital
York, Pennsylvania, United States, 17403
Actively Recruiting
21
Centennial Heart
Nashville, Tennessee, United States, 37203
Active, Not Recruiting
22
Baylor Scott & White Research Institute Dallas
Dallas, Texas, United States, 75226
Actively Recruiting
23
Houston Methodist Hospital
Houston, Texas, United States, 77030
Actively Recruiting
24
Baylor Scott and White - The Heart Hospital Baylor Plano
Plano, Texas, United States, 75093
Actively Recruiting
25
Intermountain Medical Center Heart Institute
Salt Lake City, Utah, United States, 84111
Actively Recruiting
26
Overlake Medical Center
Bellevue, Washington, United States, 98004
Actively Recruiting
27
Swedish Medical
Seattle, Washington, United States, 98122
Actively Recruiting
28
University of Washington Medical Center
Seattle, Washington, United States, 98195
Actively Recruiting
29
Basildon University Hospital
Basildon, UK, United Kingdom, SS16 5NL
Actively Recruiting
30
Bristol Heart Institute
Bristol, UK, United Kingdom, BS2 8ED
Actively Recruiting
31
Leeds Teaching Hospital NHS Trust
Leeds, UK, United Kingdom, LS1 3EX
Actively Recruiting
32
Glenfield Hospital
Leicester, UK, United Kingdom, LE3 9QP
Actively Recruiting
33
St. Thomas Hospital
London, UK, United Kingdom, SE1 7EH
Actively Recruiting
34
St. George's Hospital
London, UK, United Kingdom, SW17 0RE
Actively Recruiting
Research Team
R
Randee Randoll
CONTACT
L
Lesli DeSimone
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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