Sponsor study identifier
observational
60
1 country
1
Study Start
October 2015
Actual (reported)Primary Completion
July 2018
Actual (reported)Study Completion
December 2020
Actual (reported)This study will assess the long term safety and performance of the GORE® VIABAHN® Endoprosthesis for the treatment of patients with Popliteal Artery Aneurysms.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 29, 2015
Actual (reported)June 4, 2015
Actual (reported)October 2015
Actual (reported)July 2018
Actual (reported)July 13, 2020
Actual (reported)December 2020
Actual (reported)Number of Subjects With Primary Patency at 12 Months
Primary Patency is defined as blood flow without occlusion maintained through the device after implant without an intervention evaluated at 12 months.
12 months
Number of Subjects With a Safety-related Event at 12 Months
Safety-related events are defined as serious adverse events and adverse events related to the study procedure or the study device through 12 months
12 months
Probability of Primary Patency
12, 24, and 36 months
Number of Subject With a Safety-related Event at 24 and 36 Months
24 and 36 months
Length of Hospital Stay
During hospitalization, approximately 1-2 days
Length of Procedure
During procedure, approximately 120 minutes
Probability of Primary Assisted Patency
12, 24, and 36 months
Treatment of Popliteal Artery Aneurysm with the GORE® VIABAHN® Endoprosthesis.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients with a symptomatic aneurysm or asymptomatic aneurysm (≥ 2 cm diameter) of the popliteal artery, or presence of mural thrombus (\< 2 cm) in the popliteal artery treated since the date of reimbursement in France.
Hôpitaux Universitaire de Strasbourg
Strasbourg, France
Nabil Chakfé
Hôpitaux Universitaire de Strasbourg
60 participants (actual enrollment reported by the registry).
First Submitted
May 29, 2015
First Posted
June 4, 2015
Study Start
October 2015
Actual (reported)Treatment of Patients With Traumatic or Iatrogenic Vessel Injuries
Contact the study team to confirm eligibility.
Primary Completion
July 2018
Actual (reported)Study Completion
December 2020
Actual (reported)Last Updated
March 28, 2022
Results First Posted
July 13, 2020
Record last verified: 2022-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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