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Observational GORE® VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface Global Registry

Key facts

Who runs it
W.L.Gore & Associates
Where
Belgium, France, Germany, Greece, Italy, Netherlands, Spain, Sweden, and United Kingdom26 sites in 9 countriesChoose a country to see its sites
Trial code
Status
Active, not recruiting
People taking part
614 people, planned
Started
9 Oct 2021
Expected to end
Oct 2035
Type of study
Observational, 8 groups
Treatments tested
  • GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)
Record updated
20 August 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • Age ≥ 18 years
  • Signed informed consent form
  • Suitable for endovascular treatment with VSX based on treating physician's best medical judgment
  • Willingness of the patient to adhere to institutional standard of care follow-up requirements

Who cannot take part

  • Lesion(s) cannot be treated with available VSX Device sizes per current Instructions for Use (IFU)
  • Lesion requires treatment with an altered endoprosthesis or delivery system. (Do not cut the endoprosthesis. The endoprosthesis should only be placed and deployed using the supplied catheter system)
  • Previous or concurrent enrollment into this registry (e.g., previous enrollment into another treatment cohort or patient requires enrollment into more than one cohort) (Note: Only the first VSX treatment will be enrolled if concurrent VSX procedures are performed that would require enrollment into more than one cohort)
  • Participation in concurrent research study or registry which may confound registry results, unless approved by Gore
  • Known hypersensitivity to heparin or a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II
  • Unable to tolerate antiplatelet therapy
  • Patient has a non-controllable allergy to contrast or the VSX Device components
  • Patient has other medical conditions which, as determined by the investigator, may confound the data interpretation (e.g., sepsis, thrombophilic diseases, connective tissue disorders)
  • Non-compliant lesions where full expansion of an angioplasty balloon catheter is not achievable during pre-dilatation, or where lesions cannot be dilated sufficiently to allow passage of the delivery system
  • Use of the VSX Device in lesions involving a major side branch that may be covered by the endoprosthesis
  • Pregnant or breast-feeding female at time of informed consent signature
  • Life expectancy < 12 months due to comorbidities

This trial has no sites in United States.

It has sites in 9 countries. Choose a country to see its sites.

About the trial

What the trial wants to find out

Collect real-world post-market clinical follow-up data on patients treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)

The 8 groups in the trial

  • Iliac

    Subjects with de novo or restenotic lesions in the iliac arteries treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)

    Treatment: GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)

  • Superficial Femoral Artery (SFA)

    Subjects with de novo or restenotic lesions in the SFA and proximal popliteal arteries treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)

    Treatment: GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)

  • Superficial Femoral Artery (SFA) In-Stent Restenosis (ISR)

    Subjects with in-stent restenosis lesions in the SFA and proximal popliteal arteries treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)

    Treatment: GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)

  • AV access

    Subjects with stenosis or thrombotic occlusion at the venous anastomosis of synthetic arteriovenous (AV) access graft and in the venous outflow of dialysis access circuits, including the central veins treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)

    Treatment: GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)

  • Popliteal Artery Aneurysms

    Subjects with popliteal artery aneurysms treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)

    Treatment: GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)

  • Trauma/Injury

    Subjects with traumatic or iatrogenic vessel injuries in arteries that are located in the chest cavity, abdominal cavity, or pelvis (except for aorta, coronary, innominate, carotid, vertebral, and pulmonary arteries) treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)

    Treatment: GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)

  • Visceral Artery Aneurysms

    Subjects with isolated visceral artery aneurysms treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)

    Treatment: GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)

  • Others

    Subjects treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) but do not fit any of the cohorts listed above.

    Treatment: GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Observational GORE® VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface (VSX) Global Registry
Record updated
20 August 2026