Treatment of Popliteal Aneurysms With VIABAHN Stent Graft in Elective Surgery (VAP-AURC)

July 3, 2019 updated by: Hospices Civils de Lyon

Treatment of Popliteal Aneurysms With VIABAHN Stent Graft in Elective Surgery: Multicenter Prospective Registry of the Research in Vascular Surgery University Association (AURC)

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)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bron, France, 69677
        • Hôpital pneumologique et cardiovasculaire Louis Pradel (HCL)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study population will include all popliteal aneurysm patients treated with GORE VIABAHN® stent graft in scheduled elective surgery, whether symptomatic or asymptomatic.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major limb events
Time Frame: 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
2 years of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2019

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

September 1, 2022

Study Registration Dates

First Submitted

June 21, 2019

First Submitted That Met QC Criteria

June 21, 2019

First Posted (Actual)

June 25, 2019

Study Record Updates

Last Update Posted (Actual)

July 8, 2019

Last Update Submitted That Met QC Criteria

July 3, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VAP-AURC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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