Phase
Condition
Peripheral Arterial Occlusive Disease
Thrombosis
Aneurysm
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
Sint-Agatha-Berchem 2802247, 1082
BelgiumSite Not Available
Centre Hospitalier Unversitaire d'Angers
Angers 3037656, 49933
FranceSite Not Available
Centre Hospitalier Regional Universitaire de Brest
Brest 3030300, 29200
FranceSite Not Available
Hopital Edouard Herriot (HCL)
Lyon 2996944, 69002
FranceSite Not Available
Hospital Paris Saint-Joseph
Paris 2988507, 75014
FranceSite Not Available
Clinique RHENA
Strasbourg 2973783, 67000
FranceSite Not Available
Cardioangiologisches Centrum Bethanien
Frankfurt 2925536, 60389
GermanySite Not Available
Marien Krankenhaus
Hamburg 2911298, 22087
GermanySite Not Available
University of Heidelberg
Heidelberg 2907911, D-69120
GermanySite Not Available
Krankenhaus Reinbek St. Adolf-Stift
Reinbek 2848845, 21465
GermanySite Not Available
University Hospital Tuebingen
Tübingen 2820860, 72076
GermanySite Not Available
Papageorgiou Hospital
Pávlos 255664, 564 29
GreeceSite Not Available
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
Ancona 3183089, 60127
ItalySite Not Available
Fondazione Poliambulanza
Brescia 3181554, 25124
ItalySite Not Available
S.C. Chirurgia Vascolare dell'A.O.U. di Modena
Modena 3173331, 41124
ItalySite Not Available
Ospedale San Giovanni Molinette
Torino 8980539, 10126
ItalySite Not Available
Dipartimento di Scienze Chirurgiche e Morfologiche
Varese 3164699, 21100
ItalySite Not Available
Rijnstate
Arnhem 2759661, 6800 TA
NetherlandsSite Not Available
Medical Center Leeuwarden
Leeuwarden 2751792, 8934 AD
NetherlandsSite Not Available
Hospital Universitari Germans Trias i Pujol
Barcelona 3128760, 08916
SpainSite Not Available
Alvaro Cunqueiro Hospital
Vigo 3105976, 36213
SpainSite Not Available
Skane University Hospital
Malmo 2692969, SE-205 02
SwedenSite Not Available
Karolinska University Hospital
Solna 2675397, 171 64
SwedenSite Not Available
Southmead Hospital
Bristol 2654675, BS10 5NB
United KingdomSite Not Available
Greater Glasgow Health Board
Glasgow 2648579, G12 0XH
United KingdomSite Not Available
Queen Elizabeth Hospital
London 2643743, SE18 4QH
United KingdomSite Not Available

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