NCT04706273|CompletedResultsFDA Device
Loading search results
Sponsor study identifier
observational
321
1 country
1
Study Start
August 25, 2016
Actual (reported)Primary Completion
July 11, 2019
Actual (reported)Study Completion
December 14, 2022
Actual (reported)This study will confirm device efficacy and safety in the clinical setting after the launch of the GORE® VIABAHN® Endoprosthesis for the treatment of symptomatic peripheral arterial disease in the superficial femoral arteries.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 14, 2022
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.
August 25, 2016
Actual (reported)July 11, 2019
Actual (reported)January 8, 2021
Actual (reported)January 12, 2021
Actual (reported)December 14, 2022
Actual (reported)September 20, 2024
Actual (reported)Primary Assisted Patency
Primary assisted patency is defined as hemodynamic evidence of flow through a device that had not required a Target lesion revascularization to restore flow after total occlusion. Kaplan-Meier estimates created for each time point.
12 and 24 months
Freedom From Target Lesion Revascularization
Revascularization for restenosis or occlusion of the target lesion. Kaplan-Meier estimates created for each time point.
1, 12 and 24 months
Number of Participants With One or More Device- or Procedure-related Serious Adverse Events and Deficiencies
The number and proportion of the subjects for whom the occurrence of serious adverse events were reported.
Procedure day, 1, 12, 24, 36, 48 and 60 months
Number of Participants With a Stent Fracture
The number and proportion of stent fracture as assessed by Core lab
Month 12, 24, 36, 48 and 60
Participants with symptomatic peripheral arterial disease in superficial femoral artery lesions.
Participants receiving 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 symptomatic peripheral arterial disease in superficial femoral artery lesions in Japan
Contact the study team to confirm eligibility.
Kansai Rousai
Amagasaki, Hyōgo, Japan
Iida O, Ohki T, Soga Y, Suematsu N, Nakama T, Yamaoka T, Tobita K, Ichihashi S. Five-year outcomes of the GORE VIABAHN Endoprosthesis for the treatment of complex femoropopliteal lesions from a Japanese postmarket surveillance study. Vasc Med. 2024 Aug;29(4):416-423. doi: 10.1177/1358863X241233528. Epub 2024 Mar 27.
321 participants (actual enrollment reported by the registry).
First Submitted
January 8, 2021
First Posted
January 12, 2021
Study Start
August 25, 2016
Actual (reported)Multi-center Study for Stent Graft System for Peripheral Artery
Primary Completion
July 11, 2019
Actual (reported)Study Completion
December 14, 2022
Actual (reported)Last Updated
September 20, 2024
Results First Posted
September 20, 2024
Record last verified: 2023-10
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.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: