What is the GORE4 VIAFORT Vascular Stent studying for iliofemoral venous obstruction?

This trial is studying the GORE4 VIAFORT Vascular Stent to see how well it works and how safe it is for treating symptomatic iliofemoral venous obstruction. Researchers want to understand if this device can improve vein function and patient symptoms. The study is sponsored by W.L.Gore & Associates and involves multiple U.S. clinical sites.

Who may be eligible for this iliofemoral venous obstruction clinical trial?

Adults aged 18 and older with symptomatic unilateral iliofemoral venous obstruction may be eligible. Participants must be able to follow study visits and treatment plans, be ambulatory, and have a life expectancy of at least one year. Both men and women can join. Please review eligibility criteria for more details.

Is there any cost to participate in this iliofemoral venous obstruction clinical trial?

Study-related care, including the stent procedure and all trial visits, is provided at no cost. However, personal expenses such as travel to the study sites may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID05489588

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

Research Sites

239 weeks

Total Duration

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 devices 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 stents 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

Age: 18Years +

All Genders

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.

Research Team

Carl Conway

Leonard Resecker

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