Status:
RECRUITING
Observational GORE® VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface Global Registry
Lead Sponsor:
W.L.Gore & Associates
Conditions:
Peripheral Artery Disease
Popliteal Aneurysm
Eligibility:
All Genders
18+ years
Brief Summary
Collect real-world post-market clinical follow-up data on patients treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)
Detailed Description
This is an Observational, prospective, single-arm, multicenter, post-market registry to collect real-world post-market clinical follow-up data on patients treated with the GORE® VIABAHN® Endoprosthesi...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Signed informed consent form
- Suitable for endovascular treatment with VSX based on treating physician's best medical judgment
- Willingness of the patient to adhere to institutional standard of care follow-up requirements
Exclusion
- 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.
- Use of the VSX Device in lesions involving a major side branch that may be covered by the endoprosthesis.
- Lesion(s) cannot be treated with available VSX Device sizes per current Instructions for Use (IFU).
- 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).
- 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).
- Participation in concurrent research study or registry which may confound registry results, unless approved by Gore.
- Known hypersensitivity to heparin or a previous incident of Heparin-Induced Thrombocytopenia (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, may confound the data interpretation (e.g., sepsis, thrombophilic diseases, connective tissue disorders).
Key Trial Info
Start Date :
October 9 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2035
Estimated Enrollment :
614 Patients enrolled
Trial Details
Trial ID
NCT04907240
Start Date
October 9 2021
End Date
October 1 2035
Last Update
July 9 2025
Active Locations (27)
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1
iD3 Medical cvba
Sint-Agatha-Berchem, Belgium, 1082
2
Centre Hospitalier Unversitaire d'Angers
Angers, France, 49933
3
Centre Hospitalier Regional Universitaire de Brest
Brest, France, 29200
4
Hopital Edouard Herriot (HCL)
Lyon, France, 69002