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Clinical Trials in the UK / NCT04907240
Active, not recruiting Observational

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

NCT04907240 · tracked via the Priya Life Science UK tracker
Sponsor
W.L.Gore & Associates
Phase
Observational
Started
2021-10-09
Last updated
2026-08-20

Condition(s) studied

Peripheral Artery DiseasePopliteal AneurysmHemodialysis AccessVisceral Artery AneurysmsTrauma Injury

Investigational drug(s) / intervention(s)

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

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

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Age ≥ 18 years 2. Signed informed consent form 3. Suitable for endovascular treatment with VSX based on treating physician's best medical judgment 4. Willingness of the patient to adhere to institutional standard of care follow-up requirements Exclusion Criteria: 1. 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. 2. Use of the VSX Device in lesions involving a major side branch that may be covered by the endoprosthesis. 3. Lesion(s) cannot be treated with available VSX Device sizes per current Instructions for Use (IFU). 4. 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). 5. 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). 6. Participation in concurrent research study or registry which may confound registry results, unless approved by Gore. 7. Known hypersensitivity to heparin or a previous incident of Heparin-Induced Thrombocytopenia (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, may confound the data interpretation (e.g., sepsis, thrombophilic diseases, connective tissue disorders).

Primary outcome measure(s)

Trial sites (26)

FacilityCityRegionStatus
iD3 Medical cvba Sint-Agatha-Berchem Belgium
Centre Hospitalier Unversitaire d'Angers Angers France
Centre Hospitalier Regional Universitaire de Brest Brest France
Hopital Edouard Herriot (HCL) Lyon France
Hospital Paris Saint-Joseph Paris France
Clinique RHENA Strasbourg France
Cardioangiologisches Centrum Bethanien Frankfurt Germany
Marien Krankenhaus Hamburg Germany
University of Heidelberg Heidelberg Germany
Krankenhaus Reinbek St. Adolf-Stift Reinbek Germany
University Hospital Tuebingen Tübingen Germany
Papageorgiou Hospital Pávlos Greece
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona Ancona Italy
Fondazione Poliambulanza Brescia Italy
S.C. Chirurgia Vascolare dell'A.O.U. di Modena Modena Italy
Ospedale San Giovanni Molinette Torino Italy
Dipartimento di Scienze Chirurgiche e Morfologiche Varese Italy
Rijnstate Arnhem Netherlands
Medical Center Leeuwarden Leeuwarden Netherlands
Hospital Universitari Germans Trias i Pujol Barcelona Spain
Alvaro Cunqueiro Hospital Vigo Spain
Skane University Hospital Malmö Sweden
Karolinska University Hospital Solna Sweden
Southmead Hospital Bristol United Kingdom
Greater Glasgow Health Board Glasgow United Kingdom
Queen Elizabeth Hospital London United Kingdom

More W.L.Gore & Associates trials in the UK

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04907240 on ClinicalTrials.gov ↗ ← All trials in the UK