Actively Recruiting
Evaluation of the GORE4 VIAFORT Vascular Stent for Treatment of Symptomatic Iliofemoral Venous Obstruction
Led by W.L.Gore & Associates · Updated on 2026-04-09
165
Participants Needed
27
Research Sites
239 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the GORE4 VIABAHN4 FORTEGRA Venous Stent for treating symptomatic iliofemoral venous obstruction. This prospective, non-randomized, multicenter clinical study aims to assess the device's safety, performance, and effectiveness in patients suffering from this vein condition. The study involves multiple sites across the U.S. and is sponsored by W.L.Gore & Associates. The study involves implanting the GORE4 VIABAHN4 FORTEGRA Venous Stent into affected veins in up to 165 participants. The stent is designed to treat unilateral symptomatic iliofemoral venous obstruction. After the procedure, participants will have follow-up visits scheduled at 1, 6, 12, 24, 36, 48, and 60 months to monitor the stent's performance and safety. Participants will be evaluated through hospital discharge and during the scheduled follow-up visits. Assessments include imaging to confirm stent patency, monitoring for adverse events such as embolization or bleeding, and clinical evaluations using scales like the Revised Venous Clinical Severity Scale (rVCSS) and quality-of-life questionnaires. The study measures procedural success and monitors safety events up to 12 months, with longer-term follow-up extending to 60 months to assess sustained outcomes and device performance.
CONDITIONS
Brief 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.
- Willing and able to comply with follow-up evaluations and medication or compression regimens.
- 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 device is acceptable).
- 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.
- Presence of non-malignant unilateral obstruction of relevant veins defined as occlusion or 6550% reduction in vessel lumen.
- Ability to accommodate an appropriately sized stent and delivery sheath.
- Adequate landing zones free from significant disease beyond lesion margins.
- Lesion can be traversed with a guidewire.
- Disease involves only unilateral iliofemoral venous segments with intent to stent all affected segments.
You will not qualify if you...
- Deep vein thrombosis in target areas with symptom onset between 14 and 90 days prior to treatment.
- Pregnant or breastfeeding women, or planning pregnancy through 12-month visit.
- Clinically significant pulmonary embolism at enrollment.
- Uncorrectable bleeding disorders or active coagulopathy.
- Impaired renal function (eGFR <30 mL/min/1.73m2) or dialysis.
- Uncorrected hemoglobin less than 9 g/dL.
- History of 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 of target lower limb.
- Known sensitivity to device materials.
- Prior stenting or grafts in the target vessels.
- Active systemic infection at procedure time.
- History of intravenous drug abuse within one year of treatment.
- Significant peripheral arterial disease.
- BMI over 45 unless diagnostic quality ultrasound is possible.
- Active or planned cancer treatment.
- Hypercoagulable states unwilling to take long-term anticoagulants.
- Contraindication to thrombolytics, anticoagulants, or iodinated contrast necessary for procedure and therapy.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to hospital discharge (up to 30 days post-treatment)
Participants receive the GORE® VIAFORT Vascular Stent to treat symptomatic iliofemoral venous obstruction.
1 hospital stay for the procedure and discharge
Duration - 60 months
Participants return for follow-up visits to monitor safety, efficacy, and device performance after stent implantation.
Follow-up visits at 1, 6, 12, 24, 36, 48, and 60 months post-treatment
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
L
Leonard Resecker
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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