Treatment of Popliteal Aneurysms With VIABAHN Stent Graft in Elective Surgery

• Conditions: Popliteal Aneurysm
• Interventions: Device: Endovascular treatment of aneurysms of the popliteal artery by GORE VIABAHN® stent in elective surgery

• Registration Number: NCT03996889
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

This multicentric, prospective study will evaluate the medium-term outcomes of patients implanted with GORE VIABAHN® stent grafts for popliteal artery aneurysms in scheduled elective surgery with the registry of the Research in Vascular Surgery University Association (AURC)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-21
• Study First Submitted QC: 2019-06-21
• Study First Posted: 2019-06-25
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-03
• Last Update Posted: 2019-07-08
• Study Start: 2019-09
• Primary Completion: 2022-09
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• > 18 years old at time of treatment
• symptomatic or asymptomatic popliteal artery aneurysm needing surgery
• scheduled elective surgery

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Exclusion Criteria

• life expectancy of <1 year
• thrombotic occlusion of popliteal artery
• intolerance to antiplatelet drugs (antiaggregants)
• known allergies to GORE VIABAHN® stent graft materials/composition
• emergency surgery

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Popliteal aneurysm patients with GORE VIABAHN®	Endovascular treatment of aneurysms of the popliteal artery by GORE VIABAHN® stent in elective surgery	The study population will include all popliteal aneurysm patients treated with GORE VIABAHN® stent graft in scheduled elective surgery, whether symptomatic or asymptomatic.

Primary Outcome Measures

Name	Time	Method
Major limb events	2 years of follow-up	Composite criterion associating Target Lesion Revascularization (TLR) and Rate of major amputation.; An Echo-Doppler imaging examination will be performed and the following parameters and information should be collected: * Permeability; * Intra-stent restenosis; * Systolic pressure index

Trial Locations

Locations (1)

Hôpital pneumologique et cardiovasculaire Louis Pradel (HCL); 🇫🇷 Bron, France