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)
Freedom from Device-Related Serious Adverse Events (SAE) — 12 month No adverse event that is deemed to be device-related and serious assessed by the investigator by cohort
Trial sites (26)
Facility
City
Region
Status
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
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.
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