Treatment of Popliteal Aneurysms With VIABAHN Stent Graft in Elective Surgery
VAP-AURC
1 other identifier
observational
50
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 21, 2019
CompletedFirst Posted
Study publicly available on registry
June 25, 2019
CompletedStudy Start
First participant enrolled
September 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2022
CompletedJuly 8, 2019
July 1, 2019
3 years
June 21, 2019
July 3, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Major limb events
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
2 years of follow-up
Study Arms (1)
Popliteal aneurysm patients with GORE VIABAHN®
The study population will include all popliteal aneurysm patients treated with GORE VIABAHN® stent graft in scheduled elective surgery, whether symptomatic or asymptomatic.
Interventions
The intervention can be performed under local anesthesia (LA), regional locus (ALR) or general anesthesia (AG) (data collected) by first approach: percutaneous or conventional. The data collected are: * Number of GORE VIABAHN® stent used (length and diameter of each) * Embolization of collaterals and other related actions * Operative complications * Intraoperative fibrinolysis * Collar cover\> 2 cm * Lack of overlap in the "overlap zone" (nb: between 4 and 8 cm above the joint spacing) * Arteriography in profile, kink
Eligibility Criteria
The study population will include all popliteal aneurysm patients treated with GORE VIABAHN® stent graft in scheduled elective surgery, whether symptomatic or asymptomatic.
You may qualify if:
- \> 18 years old at time of treatment
- symptomatic or asymptomatic popliteal artery aneurysm needing surgery
- scheduled elective surgery
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital pneumologique et cardiovasculaire Louis Pradel (HCL)
Bron, 69677, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2019
First Posted
June 25, 2019
Study Start
September 1, 2019
Primary Completion
September 1, 2022
Study Completion
September 1, 2022
Last Updated
July 8, 2019
Record last verified: 2019-07