Treatment of Popliteal Aneurysms With VIABAHN Stent Graft in Elective Surgery

NCT ID: NCT03996889

Last Updated: 2019-07-08

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

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-30

Study Completion Date

2022-09-30

Brief Summary

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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

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Conditions

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Popliteal Aneurysm

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Endovascular treatment of aneurysms of the popliteal artery by GORE VIABAHN® stent in elective surgery

Intervention Type 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

Interventions

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Endovascular treatment of aneurysms of the popliteal artery by GORE VIABAHN® stent in elective surgery

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital pneumologique et cardiovasculaire Louis Pradel (HCL)

Bron, , France

Site Status

Countries

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France

Central Contacts

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Nellie DELLA SCHIAVA, MD

Role: CONTACT

4 72 11 76 76 ext. +33

Facility Contacts

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Nellie DELLA SCHIAVA, MD

Role: primary

4 72 11 76 76 ext. +33

Other Identifiers

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VAP-AURC

Identifier Type: -

Identifier Source: org_study_id

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