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

Last updated: June 19, 2024
Sponsor: W.L.Gore & Associates
Overall Status: Active - Recruiting

Phase

N/A

Condition

Aneurysm

Peripheral Arterial Occlusive Disease

Thrombosis

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

    Berchem-Sainte-Agathe, 1082
    Belgium

    Active - Recruiting

  • Centre Hospitalier Unversitaire d'Angers

    Angers, 49933
    France

    Active - Recruiting

  • Centre Hospitalier Regional Universitaire de Brest

    Brest, 29200
    France

    Active - Recruiting

  • Hopital Edouard Herriot (HCL)

    Lyon, 69002
    France

    Active - Recruiting

  • Hospital Paris Saint-Joseph

    Paris, 75014
    France

    Active - Recruiting

  • Clinique RHENA

    Strasbourg, 67000
    France

    Active - Recruiting

  • Cardioangiologisches Centrum Bethanien

    Frankfurt, 60389
    Germany

    Active - Recruiting

  • Marien Krankenhaus

    Hamburg, 22087
    Germany

    Active - Recruiting

  • University of Heidelberg

    Heidelberg, D-69120
    Germany

    Active - Recruiting

  • Saarland University Medical Center

    Homburg, D-66421
    Germany

    Site Not Available

  • Krankenhaus Reinbek St. Adolf-Stift

    Reinbek, 21465
    Germany

    Active - Recruiting

  • University Hospital Tuebingen

    Tuebingen, 72076
    Germany

    Active - Recruiting

  • Papageorgiou Hospital

    Pavlos, 564 29
    Greece

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona

    Ancona, 60127
    Italy

    Active - Recruiting

  • Fondazione Poliambulanza

    Brescia, 25124
    Italy

    Active - Recruiting

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

    Modena, 41124
    Italy

    Active - Recruiting

  • Ospedale San Giovanni Molinette

    Torino, 10126
    Italy

    Active - Recruiting

  • Dipartimento di Scienze Chirurgiche e Morfologiche

    Varese, 21100
    Italy

    Active - Recruiting

  • Rijnstate

    Arnhem, 6800 TA
    Netherlands

    Active - Recruiting

  • Medical Center Leeuwarden

    Leeuwarden, 8934 AD
    Netherlands

    Active - Recruiting

  • Hospital Universitario Cruces

    Barakaldo, 48903
    Spain

    Site Not Available

  • Hospital Universitari Germans Trias i Pujol

    Barcelona, 08916
    Spain

    Active - Recruiting

  • Alvaro Cunqueiro Hospital

    Vigo, 36213
    Spain

    Active - Recruiting

  • Skane University Hospital

    Malmo, SE-205 02
    Sweden

    Active - Recruiting

  • Karolinska University Hospital

    Solna, 171 64
    Sweden

    Active - Recruiting

  • Southmead Hospital

    Bristol, BS10 5NB
    United Kingdom

    Active - Recruiting

  • Greater Glasgow Health Board

    Glasgow, G12 0XH
    United Kingdom

    Active - Recruiting

  • Queen Elizabeth Hospital

    London, SE18 4QH
    United Kingdom

    Active - Recruiting

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