Phase
Condition
Aneurysm
Peripheral Arterial Occlusive Disease
Thrombosis
Treatment
GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥ 18 years
Signed informed consent form
Suitable for endovascular treatment with VSX based on treating physician's bestmedical judgment
Willingness of the patient to adhere to institutional standard of care follow-uprequirements
Exclusion
Exclusion Criteria:
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.
Use of the VSX Device in lesions involving a major side branch that may be coveredby the endoprosthesis.
Lesion(s) cannot be treated with available VSX Device sizes per current Instructionsfor Use (IFU).
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).
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).
Participation in concurrent research study or registry which may confound registryresults, unless approved by Gore.
Known hypersensitivity to heparin or a previous incident of Heparin-InducedThrombocytopenia (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, mayconfound the data interpretation (e.g., sepsis, thrombophilic diseases, connectivetissue disorders).
Study Design
Study Description
Connect with a study center
iD3 Medical cvba
Berchem-Sainte-Agathe, 1082
BelgiumActive - Recruiting
Centre Hospitalier Unversitaire d'Angers
Angers, 49933
FranceActive - Recruiting
Centre Hospitalier Regional Universitaire de Brest
Brest, 29200
FranceActive - Recruiting
Hopital Edouard Herriot (HCL)
Lyon, 69002
FranceActive - Recruiting
Hospital Paris Saint-Joseph
Paris, 75014
FranceActive - Recruiting
Clinique RHENA
Strasbourg, 67000
FranceActive - Recruiting
Cardioangiologisches Centrum Bethanien
Frankfurt, 60389
GermanyActive - Recruiting
Marien Krankenhaus
Hamburg, 22087
GermanyActive - Recruiting
University of Heidelberg
Heidelberg, D-69120
GermanyActive - Recruiting
Saarland University Medical Center
Homburg, D-66421
GermanySite Not Available
Krankenhaus Reinbek St. Adolf-Stift
Reinbek, 21465
GermanyActive - Recruiting
University Hospital Tuebingen
Tuebingen, 72076
GermanyActive - Recruiting
Papageorgiou Hospital
Pavlos, 564 29
GreeceActive - Recruiting
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
Ancona, 60127
ItalyActive - Recruiting
Fondazione Poliambulanza
Brescia, 25124
ItalyActive - Recruiting
S.C. Chirurgia Vascolare dell'A.O.U. di Modena
Modena, 41124
ItalyActive - Recruiting
Ospedale San Giovanni Molinette
Torino, 10126
ItalyActive - Recruiting
Dipartimento di Scienze Chirurgiche e Morfologiche
Varese, 21100
ItalyActive - Recruiting
Rijnstate
Arnhem, 6800 TA
NetherlandsActive - Recruiting
Medical Center Leeuwarden
Leeuwarden, 8934 AD
NetherlandsActive - Recruiting
Hospital Universitario Cruces
Barakaldo, 48903
SpainSite Not Available
Hospital Universitari Germans Trias i Pujol
Barcelona, 08916
SpainActive - Recruiting
Alvaro Cunqueiro Hospital
Vigo, 36213
SpainActive - Recruiting
Skane University Hospital
Malmo, SE-205 02
SwedenActive - Recruiting
Karolinska University Hospital
Solna, 171 64
SwedenActive - Recruiting
Southmead Hospital
Bristol, BS10 5NB
United KingdomActive - Recruiting
Greater Glasgow Health Board
Glasgow, G12 0XH
United KingdomActive - Recruiting
Queen Elizabeth Hospital
London, SE18 4QH
United KingdomActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.