Observational GORE® VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface Global Registry
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Treatments
Details and patient eligibility
About
Collect real-world post-market clinical follow-up data on patients treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)
Full 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® Endoprosthesis with PROPATEN Bioactive Surface (VSX) for one of the following indications: Iliac, Superficial Femoral Artery (SFA), Superficial Femoral Artery In-stent restenosis (SFA ISR), Hemodialysis access (AV access), Visceral artery aneurysms (VAA), Trauma/Injury, Popliteal Artery Aneurysms (PAA), or Other. Approximately 35 sites in Europe will participate and a minimum of 614 patients will be enrolled in this registry. All consecutive patients meeting protocol selection criteria, consented, with an intention to be treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) will be included and followed through one year for Trauma/Injury and other; three years for VAA; five years for Iliac, SFA, SFA ISR and AV access and ten years for PAA per institutional standard of care.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- 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 criteria
- 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).
Trial design
614 participants in 8 patient groups
Trial contacts and locations
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Central trial contact
Cagla Selvan; Alexandre Figard
Data sourced from clinicaltrials.gov
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