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出境医 / 临床实验 / Treatment of Popliteal Aneurysms With VIABAHN Stent Graft in Elective Surgery (VAP-AURC)

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

Study Description
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)

Condition or disease Intervention/treatment
Popliteal Aneurysm Device: Endovascular treatment of aneurysms of the popliteal artery by GORE VIABAHN® stent in elective surgery

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Treatment of Popliteal Aneurysms With VIABAHN Stent Graft in Elective Surgery: Multicenter Prospective Registry of the Research in Vascular Surgery University Association (AURC)
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022
Arms 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
Outcome Measures
Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Nellie DELLA SCHIAVA, MD 4 72 11 76 76 ext +33 dellaschiava.nellie@neuf.fr

Locations
Layout table for location information
France
Hôpital pneumologique et cardiovasculaire Louis Pradel (HCL)
Bron, France, 69677
Contact: Nellie DELLA SCHIAVA, MD    4 72 11 76 76 ext +33    dellaschiava.nellie@neuf.fr   
Principal Investigator: Nellie DELLA SCHIAVA, MD         
Sponsors and Collaborators
Hospices Civils de Lyon
Tracking Information
First Submitted Date June 21, 2019
First Posted Date June 25, 2019
Last Update Posted Date July 8, 2019
Estimated Study Start Date September 2019
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 3, 2019) 		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
Original Primary Outcome Measures
 (submitted: June 21, 2019)
  • Target Lesion Revascularization (TLR) [ Time Frame: 2 years of follow-up ]
    An Echo-Doppler imaging examination will be performed and the following parameters and information should be collected:
    • Permeability
    • Intra-stent restenosis
    • Systolic pressure index
  • Rate of major amputation [ Time Frame: 2 years of follow-up ]
    An Echo-Doppler imaging examination will be performed and the following parameters and information should be collected:
    • Permeability
    • Intra-stent restenosis
    • Systolic pressure index
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Treatment of Popliteal Aneurysms With VIABAHN Stent Graft in Elective Surgery
Official Title Treatment of Popliteal Aneurysms With VIABAHN Stent Graft in Elective Surgery: Multicenter Prospective Registry of the Research in Vascular Surgery University Association (AURC)
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 Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Popliteal Aneurysm
Intervention 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
Study Groups/Cohorts 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.
Intervention: Device: Endovascular treatment of aneurysms of the popliteal artery by GORE VIABAHN® stent in elective surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: June 21, 2019) 		50
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2022
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Nellie DELLA SCHIAVA, MD 4 72 11 76 76 ext +33 dellaschiava.nellie@neuf.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03996889
Other Study ID Numbers VAP-AURC
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Hospices Civils de Lyon
Study Sponsor Hospices Civils de Lyon
Collaborators Not Provided
Investigators Not Provided
PRS Account Hospices Civils de Lyon
Verification Date July 2019

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