Informations générales (source: ClinicalTrials.gov)
Observational GORE® VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface (VSX) Global Registry
Observational [Patient Registry]
W.L.Gore & Associates (Voir sur ClinicalTrials)
octobre 2021
octobre 2035
25 juin 2024
Collect real-world post-market clinical follow-up data on patients treated with the GORE®
VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| GH PARIS SITE SAINT JOSEPH | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Hospitalier Regional Universitaire de Brest - 29200 - Brest - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Unversitaire d'Angers - 49933 - Angers - France | Contact (sur clinicalTrials) | ||||
| Clinique RHENA - 67000 - Strasbourg - France | Contact (sur clinicalTrials) | ||||
| Hopital Edouard Herriot (HCL) - 69002 - Lyon - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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
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
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).