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Evaluation of the GORE® VIAFORT Vascular Stent for treating iliofemoral venous obstruction

Evaluation of the GORE® VIAFORT Vascular Stent for Treatment of Symptomatic Iliofemoral Venous Obstruction

Not applicable Interventional W.L.Gore & Associates · NCT05489588

This study is testing a new stent to see if it can help people with painful iliofemoral vein blockages feel better.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment165 (estimated)
Ages18 Years and up
SexAll
SponsorW.L.Gore & Associates Industry-sponsored
Locations27 sites (Stanford, California and 26 other locations)
Trial IDNCT05489588 on ClinicalTrials.gov

What this trial studies

This clinical study aims to assess the performance, safety, and efficacy of the GORE® VIAFORT Vascular Stent in patients suffering from symptomatic iliofemoral venous obstruction. Conducted at up to 25 clinical sites across the U.S., the study will involve 165 subjects who will receive the stent and be monitored through hospital discharge and follow-up visits at various intervals up to 60 months post-treatment. The study is non-randomized and single-arm, focusing on the outcomes of the stent implantation in a specific patient population.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with symptomatic unilateral iliofemoral venous obstruction and a CEAP classification of 3 or higher.

Not a fit: Patients with deep vein thrombosis in the target areas that occurred more than 14 days but less than 90 days prior to treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients suffering from severe venous obstruction, potentially improving their quality of life.

How similar studies have performed: Other studies have shown promising results with similar vascular stent approaches, indicating potential for success in this novel application.

Eligibility criteria

Show full inclusion / exclusion criteria 
Preoperative Inclusion Criteria:

* Patient is at least 18 years of age.
* Patient is willing and able to comply with all follow-up evaluations as well as any required medication or compression regimen.
* Patient is able to provide informed consent.
* One of the following: Clinical severity class of CEAP 'C' classification ≥3 or rVCSS pain score ≥2.
* Intention to treat the target areas with only the GORE® VIAFORT Vascular Stent.
* Estimated life expectancy ≥1 year.
* Patient is ambulatory (use of assistive walking device such as a cane or walker is acceptable).
* Patient has adequate inflow to the target lesion(s), per investigator/sub-investigator discretion, involving at least a patent femoral or deep femoral vein.
* Presence of non-malignant symptomatic unilateral iliofemoral venous obstruction.

Preoperative Exclusion Criteria:

* Patient has DVT in the target areas with symptom onset date greater than 14 days but less than or equal to 90 days prior to treatment.
* Patient is a pregnant or breastfeeding woman, or a woman planning to become pregnant through the 12-month visit.
* Patient has clinically significant (e.g., symptoms of chest pain, hemoptysis, dyspnea, hypoxia, etc.) pulmonary embolism (confirmed via Computed Tomography Angiography) at the time of enrollment.
* Patient has a known uncorrectable bleeding diathesis or active coagulopathy meeting the following definitions (all must be tested for):

  1. uncorrected INR\>2 (not as a result of warfarin or DOAC therapy), OR
  2. platelet count \<50,000 or \>1,000,000 cells/mm3, OR
  3. white blood cell count \<3,000 or \>12,500 cells/mm3
* Patient has impaired renal function (eGFR \<30 mL/min/1.73m2) or is currently on dialysis.
* Patient has uncorrected hemoglobin of \<9 g/dL.
* Patient has known history of antiphospholipid syndrome (APS).
* Patient has known homozygous or acquired coagulation defect (e.g., Protein C or Protein S deficiency) that cannot be treated with therapeutic anticoagulation.
* Patient has a planned surgical intervention that has the potential to clinically interfere with the endpoints of this treatment (other than pre-stenting procedures such as thrombolysis or thrombectomy) within 30 days prior to or within 30 days after the planned study procedure. Examples include surgical interventions that may impact mobility, and surgical interventions that require cessation of therapeutic antiplatelet or anticoagulation within 30 days following the index procedure.
* Patient has had or requires open deep venous surgery in the target limb.
* Patient is currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this treatment, in the opinion of the investigator/sub-investigator. Observational studies are permitted.
* Patient has had a previous major (i.e., above the ankle) amputation of the target lower limb.
* Patient has known sensitivity to device materials.
* Patient has had prior stenting or grafts in the target vessels.
* Patient has a known or suspected active systemic infection at the time of the index procedure. Patients with a chronic infection (e.g., HIV, hepatitis C) that can be managed, and with an active clinical plan in place may be eligible.
* Patient has known history of intravenous drug abuse within one year of treatment.
* Patient has significant peripheral arterial disease (chronic Rutherford Type 2 or greater, acute Rutherford Type IIa or greater).
* Patient has a BMI \>45. Patients with a BMI of up to 45 may be enrolled provided that diagnostic quality ultrasound of the implant sites can be performed.
* Patient is actively undergoing or plans to begin cancer treatment.
* Patients with hypercoagulable states that are unwilling to take anticoagulant medications on a long-term basis.
* Patient has contraindication to thrombolytics, anticoagulants, or iodinated contrast necessary for the index procedure and long-term medical therapy (contrast pre-medication is acceptable).

Intraoperative Inclusion Criteria:

* Presence of non-malignant unilateral obstruction of the common femoral vein, external iliac vein, and/or common iliac vein defined as occlusion or at least 50% reduction in target vessel lumen as measured by procedural IVUS and venogram.
* Patient can accommodate an appropriately sized GORE® VIAFORT Vascular Stent as per reference vessel diameter (see IFU), as determined by intraoperative IVUS post pre-dilation.
* Patient must have appropriate access vessels to accommodate the delivery sheath for the selected device size.
* Patient has adequate landing zones free from significant disease requiring treatment within the native vessels beyond the proximal and distal margins of the lesion.
* Patient has adequate inflow to the target lesion(s), per investigator/sub-investigator discretion, involving at least a patent femoral or deep femoral vein.
* Lesion can be traversed with a guidewire.
* Disease involves only unilateral iliofemoral venous segments with intent to stent all affected iliofemoral segments. Patients with disease extending into the inferior vena cava or contra-lateral iliofemoral veins who are anticipated to require endovascular or surgical treatment within 12 months after investigational device implant will be excluded.
* Patient does not have significant (i.e., \>20% residual thrombosis) acute thrombus within the target stent area at the time of investigational device placement. Patients with acute thrombus within the target stent area must have thrombus successfully treated prior to investigational device placement. Successful thrombus treatment is defined as reestablishment of antegrade flow with ≤20% residual thrombosis as confirmed by IVUS and venogram, AND freedom from bleeding, vascular injury, or hemodynamically significant pulmonary embolism. After successful thrombus treatment, investigational device placement can occur within the same procedure.

Where this trial is running

Stanford, California and 26 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Venous ThrombosesVenous DiseaseVenous Leg UlcerVenous StasisVenous UlcerVenous StenosisVenous OcclusionVein Thrombosis
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.