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

NCT04907240 | Active Not Recruiting

• 1 other identifier: VSX 20-03
• Study Type: observational
• Target: 614
• Locations: 9 countries
• Sites: 26

Brief Summary

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

Conditions

Popliteal Aneurysm; Hemodialysis Access; Trauma Injury; Peripheral Artery Disease; Visceral Artery Aneurysms

Keywords

Viabahn; EVAR; Propaten; Iliac; SFA; SFA ISR; AV access; VAA; PAA; Trauma; Injury

Outcome Measures

Primary Outcomes (1)

• Freedom from Device-Related Serious Adverse Events (SAE)

  No adverse event that is deemed to be device-related and serious assessed by the investigator by cohort

  12 month

Secondary Outcomes (14)

• Freedom from Device-Related Serious Adverse Events (SAE) for patients treated specifically with PAHR09-13

  36 months

• Freedom from Target Lesion Revascularization (TLR) for patients treated specifically with PAHR09-13

  36 months

• Primary patency for subjects treated in iliac

  60 months

• Freedom from major amputation for subjects treated in iliac

  60 months

• Freedom from Target Lesion Revascularization (TLR) for subjects treated in SFA de novo / restenotic and SFA ISR

  60 months

Study Arms (8)

Iliac

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

Device: 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)

Device: 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)

Device: 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)

Device: 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)

Device: 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)

Device: 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)

Device: 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.

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

Interventions

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

Intent to treat with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) in the treatment of Peripheral Artery Disease as part of routine clinical practice.

AV access; Iliac; Others; Popliteal Artery Aneurysms; Superficial Femoral Artery (SFA); Superficial Femoral Artery (SFA) In-Stent Restenosis (ISR); Trauma/Injury; Visceral Artery Aneurysms

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients presenting with an indication for endovascular repair of one of the eight indications (iliac, SFA, SFA ISR, VAA, PAA, Trauma/Injury, AV access and others) are eligible for screening for participation in the registry. Only patients who meet all inclusion and no exclusion criteria, and who consent to participate will be enrolled.

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.
• Pregnant or breast-feeding female at time of informed consent signature.
• Life expectancy \< 12 months due to comorbidities.
• Patient has other medical conditions which, as determined by the investigator, may confound the data interpretation (e.g., sepsis, thrombophilic diseases, connective tissue disorders).

Sponsors & Collaborators

• W.L.Gore & Associates: lead

Study Sites (26)

iD3 Medical cvba

Sint-Agatha-Berchem, 1082, Belgium

Location

Centre Hospitalier Unversitaire d'Angers

Angers, 49933, France

Location

Centre Hospitalier Regional Universitaire de Brest

Brest, 29200, France

Location

Hopital Edouard Herriot (HCL)

Lyon, 69002, France

Location

Hospital Paris Saint-Joseph

Paris, 75014, France

Location

Clinique RHENA

Strasbourg, 67000, France

Location

Cardioangiologisches Centrum Bethanien

Frankfurt, 60389, Germany

Location

Marien Krankenhaus

Hamburg, 22087, Germany

Location

University of Heidelberg

Heidelberg, D-69120, Germany

Location

Krankenhaus Reinbek St. Adolf-Stift

Reinbek, 21465, Germany

Location

University Hospital Tuebingen

Tübingen, 72076, Germany

Location

Papageorgiou Hospital

Pávlos, 564 29, Greece

Location

Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona

Ancona, 60127, Italy

Location

Fondazione Poliambulanza

Brescia, 25124, Italy

Location

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

Modena, 41124, Italy

Location

Ospedale San Giovanni Molinette

Torino, 10126, Italy

Location

Dipartimento di Scienze Chirurgiche e Morfologiche

Varese, 21100, Italy

Location

Rijnstate

Arnhem, 6800 TA, Netherlands

Location

Medical Center Leeuwarden

Leeuwarden, 8934 AD, Netherlands

Location

Hospital Universitari Germans Trias i Pujol

Barcelona, 08916, Spain

Location

Alvaro Cunqueiro Hospital

Vigo, 36213, Spain

Location

Skane University Hospital

Malmo, SE-205 02, Sweden

Location

Karolinska University Hospital

Solna, 171 64, Sweden

Location

Southmead Hospital

Bristol, BS10 5NB, United Kingdom

Location

Greater Glasgow Health Board

Glasgow, G12 0XH, United Kingdom

Location

Queen Elizabeth Hospital

London, SE18 4QH, United Kingdom

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Popliteal Artery Aneurysm; Accidental Injuries; Wounds and Injuries

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Aneurysm

Study Officials

• Michel Reijnen, MD, PhD

  Rijnstate Hospital, Arnhem, The Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: May 28, 2021
• Study Start: October 9, 2021
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2035
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3); SE (2); ES (2); DE (5); GR (1); FR (5); NL (2); BE (1); IT (5)