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Treatment of Popliteal Aneurysms With VIABAHN Stent Graft in Elective Surgery

NCT03996889 — Unknown, 50 participants, Hospices Civils de Lyon
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Treatment of Popliteal Aneurysms With VIABAHN Stent Graft in Elective Surgery: Multicenter Prospective Registry of the Research in Vascular Surgery University Association (AURC)

RegistryNCT03996889, acronym VAP-AURC
StatusUnknown
Study typeObservational
Enrollment50 (Estimated)
SponsorHospices Civils de Lyon (Other)
ConditionsPopliteal Aneurysm
InterventionsEndovascular treatment of aneurysms of the popliteal artery by GORE VIABAHN® stent in elective surgery (Device)
Datesstart 2019-09-01 (estimated), primary completion 2022-09-01 (estimated), completion 2022-09-01 (estimated), first posted 2019-06-25, last updated 2019-07-08
Locations1 site in France

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-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)

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+Arms and interventions

ArmTypeInterventionsDescription
Popliteal aneurysm patients with GORE VIABAHN®Device: Endovascular treatment of aneurysms of the popliteal artery by GORE VIABAHN® stent in elective surgeryThe study population will include all popliteal aneurysm patients treated with GORE VIABAHN® stent graft in scheduled elective surgery, whether symptomatic or asymptomatic.
  • Endovascular treatment of aneurysms of the popliteal artery by GORE VIABAHN® stent in elective surgery (Device): 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

+Outcome measures

Primary outcomes

  • 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

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

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

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

+Locations (1)

FacilityCityCountryStatus
Hôpital pneumologique et cardiovasculaire Louis Pradel (HCL)BronFrance

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