Actively Recruiting
The GORE® VIABAHN® FORTEGRA Venous Stent Iliofemoral Study
Led by W.L.Gore & Associates · Updated on 2026-04-09
165
Participants Needed
27
Research Sites
417 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a prospective, non-randomized, multicenter, single-arm, clinical study to evaluate the performance, safety and efficacy of the GORE® VIABAHN® FORTEGRA Venous Stent (formerly known as GORE® VIAFORT Vascular Stent) for treatment of symptomatic iliofemoral venous obstruction.
CONDITIONS
Official Title
The GORE® VIABAHN® FORTEGRA Venous Stent Iliofemoral Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is at least 18 years of age.
- Patient is willing and able to comply with all follow-up evaluations and any required medication or compression regimen.
- Patient is able to provide informed consent.
- Clinical severity class of CEAP 'C' classification 653 or rVCSS pain score 652.
- Intention to treat the target areas with only the GORE4 VIAFORT Vascular Stent.
- Estimated life expectancy of at least 1 year.
- Patient is ambulatory; use of assistive walking devices like a cane or walker is acceptable.
- Patient has adequate inflow to the target lesion(s), involving at least a patent femoral or deep femoral vein.
- Presence of non-malignant symptomatic unilateral iliofemoral venous obstruction.
- Intraoperative criteria including presence of non-malignant unilateral obstruction of specified veins with occlusion or at least 50% narrowing confirmed by imaging.
- Patient can accommodate the stent size based on vessel diameter.
- Patient has appropriate access vessels for device delivery.
- Adequate landing zones free from significant disease beyond lesion margins.
- Lesion can be crossed with a guidewire.
- Disease involves only unilateral iliofemoral venous segments with intent to stent all affected segments.
- No significant acute thrombus within the target stent area at device placement time, or successful thrombus treatment prior to placement.
You will not qualify if you...
- DVT in the target areas with symptom onset greater than 14 days but less than or equal to 90 days before treatment.
- Pregnant or breastfeeding women, or women planning pregnancy through 12-month visit.
- Clinically significant pulmonary embolism confirmed by CT angiography at enrollment.
- Known uncorrectable bleeding disorders or active coagulopathy.
- Impaired kidney function (eGFR <30 mL/min/1.73m2) or on dialysis.
- Uncorrected hemoglobin less than 9 g/dL.
- Known antiphospholipid syndrome.
- Known homozygous or acquired coagulation defects not treatable with anticoagulation.
- Planned surgical interventions that may interfere with study endpoints within 30 days before or after procedure.
- Prior open deep venous surgery in target limb.
- Participation in another investigational drug or device study interfering with endpoints.
- Previous major amputation above the ankle of the target limb.
- Known sensitivity to device materials.
- Prior stenting or grafts in target vessels.
- Known or suspected active systemic infection at procedure time.
- History of intravenous drug abuse within one year of treatment.
- Significant peripheral arterial disease of specified severity.
- BMI greater than 45 unless adequate ultrasound imaging possible.
- Actively undergoing or planning cancer treatment.
- Hypercoagulable states with unwillingness to take long-term anticoagulants.
- Contraindication to thrombolytics, anticoagulants, or iodinated contrast needed for procedure and therapy.
AI-Screening
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Trial Site Locations
Total: 27 locations
1
Stanford University School of Medicine
Stanford, California, United States, 94305
Actively Recruiting
2
Advanced Heart and Vein (ClinRe)
Thornton, Colorado, United States, 80023
Withdrawn
3
Vascular Care Group
Darien, Connecticut, United States, 06820
Actively Recruiting
4
Yale University
New Haven, Connecticut, United States, 06519
Actively Recruiting
5
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
6
Manatee Memorial Hospital
Bradenton, Florida, United States, 34208
Actively Recruiting
7
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
8
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
9
Vascular Care Group
Wellesley, Massachusetts, United States, 02482
Actively Recruiting
10
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
11
Englewood Hospital & Med Center
Englewood, New Jersey, United States, 07631
Actively Recruiting
12
Holy Name Medical Center
Teaneck, New Jersey, United States, 07666
Withdrawn
13
Mount Sinai Medical Center
New York, New York, United States, 10029
Actively Recruiting
14
Stony Brook
Stony Brook, New York, United States, 11790
Actively Recruiting
15
St. Peter's Vascular Associates
Troy, New York, United States, 12180
Actively Recruiting
16
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
17
Atrium Health-Sanger Heart and Vascular Institute
Charlotte, North Carolina, United States, 28204
Actively Recruiting
18
NC Heart and Vascular Research
Raleigh, North Carolina, United States, 27519
Actively Recruiting
19
Bethesda North
Cincinnati, Ohio, United States, 45242
Actively Recruiting
20
University Hospitals Cleveland
Cleveland, Ohio, United States, 44106
Actively Recruiting
21
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
22
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 14213
Actively Recruiting
23
The Miriam Hospital
Providence, Rhode Island, United States, 02906
Actively Recruiting
24
UT Southwestern
Dallas, Texas, United States, 75390
Actively Recruiting
25
Sentara General Hospital
Norfolk, Virginia, United States, 23507
Actively Recruiting
26
Overlake Hospital
Bellevue, Washington, United States, 98004
Actively Recruiting
27
Medical College of Wisconsin - Froedtert Hospital
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
C
Carl Conway
CONTACT
L
Leonard Resecker
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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