Observational GORE® VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface Global Registry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

614 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-09

Study Completion Date

2035-10-31

Brief Summary

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Collect real-world post-market clinical follow-up data on patients treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)

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Detailed Description

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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.

Conditions

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Peripheral Artery Disease Popliteal Aneurysm Hemodialysis Access Visceral Artery Aneurysms Trauma Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Iliac

Subjects with de novo or restenotic lesions in the iliac arteries treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)