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

Last updated: January 29, 2026
Sponsor: W.L.Gore & Associates
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Peripheral Arterial Occlusive Disease

Thrombosis

Aneurysm

Treatment

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

Clinical Study ID

NCT04907240
VSX 20-03
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥ 18 years

  2. Signed informed consent form

  3. Suitable for endovascular treatment with VSX based on treating physician's bestmedical judgment

  4. Willingness of the patient to adhere to institutional standard of care follow-uprequirements

Exclusion

Exclusion Criteria:

  1. Non-compliant lesions where full expansion of an angioplasty balloon catheter is notachievable during pre-dilatation, or where lesions cannot be dilated sufficiently toallow passage of the delivery system.

  2. Use of the VSX Device in lesions involving a major side branch that may be coveredby the endoprosthesis.

  3. Lesion(s) cannot be treated with available VSX Device sizes per current Instructionsfor Use (IFU).

  4. Lesion requires treatment with an altered endoprosthesis or delivery system. (Do notcut the endoprosthesis. The endoprosthesis should only be placed and deployed usingthe supplied catheter system).

  5. Previous or concurrent enrollment into this registry (e.g., previous enrollment intoanother treatment cohort or patient requires enrollment into more than one cohort) (Note: Only the first VSX treatment will be enrolled if concurrent VSX proceduresare performed that would require enrollment into more than one cohort).

  6. Participation in concurrent research study or registry which may confound registryresults, unless approved by Gore.

  7. Known hypersensitivity to heparin or a previous incident of Heparin-InducedThrombocytopenia (HIT) type II.

  8. Unable to tolerate antiplatelet therapy.

  9. Patient has a non-controllable allergy to contrast or the VSX Device components.

  10. Pregnant or breast-feeding female at time of informed consent signature.

  11. Life expectancy < 12 months due to comorbidities.

  12. Patient has other medical conditions which, as determined by the investigator, mayconfound the data interpretation (e.g., sepsis, thrombophilic diseases, connectivetissue disorders).

Study Design

Total Participants: 614
Treatment Group(s): 1
Primary Treatment: GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)
Phase:
Study Start date:
October 09, 2021
Estimated Completion Date:
October 31, 2035

Study Description

This is an Observational, prospective, single-arm, multicenter, post-market registry to collect real-world post-market clinical follow-up data on patients treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) for one of the following indications: Iliac, Superficial Femoral Artery (SFA), Superficial Femoral Artery In-stent restenosis (SFA ISR), Hemodialysis access (AV access), Visceral artery aneurysms (VAA), Trauma/Injury, Popliteal Artery Aneurysms (PAA), or Other. Approximately 35 sites in Europe will participate and a minimum of 614 patients will be enrolled in this registry. All consecutive patients meeting protocol selection criteria, consented, with an intention to be treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) will be included and followed through one year for Trauma/Injury and other; three years for VAA; five years for Iliac, SFA, SFA ISR and AV access and ten years for PAA per institutional standard of care.

Connect with a study center

  • iD3 Medical cvba

    Sint-Agatha-Berchem 2802247, 1082
    Belgium

    Site Not Available

  • Centre Hospitalier Unversitaire d'Angers

    Angers 3037656, 49933
    France

    Site Not Available

  • Centre Hospitalier Regional Universitaire de Brest

    Brest 3030300, 29200
    France

    Site Not Available

  • Hopital Edouard Herriot (HCL)

    Lyon 2996944, 69002
    France

    Site Not Available

  • Hospital Paris Saint-Joseph

    Paris 2988507, 75014
    France

    Site Not Available

  • Clinique RHENA

    Strasbourg 2973783, 67000
    France

    Site Not Available

  • Cardioangiologisches Centrum Bethanien

    Frankfurt 2925536, 60389
    Germany

    Site Not Available

  • Marien Krankenhaus

    Hamburg 2911298, 22087
    Germany

    Site Not Available

  • University of Heidelberg

    Heidelberg 2907911, D-69120
    Germany

    Site Not Available

  • Krankenhaus Reinbek St. Adolf-Stift

    Reinbek 2848845, 21465
    Germany

    Site Not Available

  • University Hospital Tuebingen

    Tübingen 2820860, 72076
    Germany

    Site Not Available

  • Papageorgiou Hospital

    Pávlos 255664, 564 29
    Greece

    Site Not Available

  • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona

    Ancona 3183089, 60127
    Italy

    Site Not Available

  • Fondazione Poliambulanza

    Brescia 3181554, 25124
    Italy

    Site Not Available

  • S.C. Chirurgia Vascolare dell'A.O.U. di Modena

    Modena 3173331, 41124
    Italy

    Site Not Available

  • Ospedale San Giovanni Molinette

    Torino 8980539, 10126
    Italy

    Site Not Available

  • Dipartimento di Scienze Chirurgiche e Morfologiche

    Varese 3164699, 21100
    Italy

    Site Not Available

  • Rijnstate

    Arnhem 2759661, 6800 TA
    Netherlands

    Site Not Available

  • Medical Center Leeuwarden

    Leeuwarden 2751792, 8934 AD
    Netherlands

    Site Not Available

  • Hospital Universitari Germans Trias i Pujol

    Barcelona 3128760, 08916
    Spain

    Site Not Available

  • Alvaro Cunqueiro Hospital

    Vigo 3105976, 36213
    Spain

    Site Not Available

  • Skane University Hospital

    Malmo 2692969, SE-205 02
    Sweden

    Site Not Available

  • Karolinska University Hospital

    Solna 2675397, 171 64
    Sweden

    Site Not Available

  • Southmead Hospital

    Bristol 2654675, BS10 5NB
    United Kingdom

    Site Not Available

  • Greater Glasgow Health Board

    Glasgow 2648579, G12 0XH
    United Kingdom

    Site Not Available

  • Queen Elizabeth Hospital

    London 2643743, SE18 4QH
    United Kingdom

    Site Not Available

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