Observational GOREĀ® VIABAHNĀ® Endoprosthesis With PROPATEN Bioactive Surface Global Registry (NCT04907240) | Clinical Trial Compass
Active ā Not RecruitingNot Applicable
Observational GOREĀ® VIABAHNĀ® Endoprosthesis With PROPATEN Bioactive Surface Global Registry
Belgium, France614 participantsStarted 2021-10-09
Plain-language summary
Collect real-world post-market clinical follow-up data on patients treated with the GOREĀ® VIABAHNĀ® Endoprosthesis with PROPATEN Bioactive Surface (VSX)
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Age ā„ 18 years
ā. Signed informed consent form
ā. Suitable for endovascular treatment with VSX based on treating physician's best medical judgment
ā. Willingness of the patient to adhere to institutional standard of care follow-up requirements
Exclusion criteria
ā. 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.
ā. Use of the VSX Device in lesions involving a major side branch that may be covered by the endoprosthesis.
ā. Lesion(s) cannot be treated with available VSX Device sizes per current Instructions for Use (IFU).
ā. 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).
ā. 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).
ā. Participation in concurrent research study or registry which may confound registry results, unless approved by Gore.
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What they're measuring
1
Freedom from Device-Related Serious Adverse Events (SAE)