GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study (JPS 16-03)
NCT ID: NCT04706273
Last Updated: 2024-09-20
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
321 participants
OBSERVATIONAL
2016-08-25
2022-12-14
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of the GORE® VIABAHN® Endoprosthesis for the Treatment of Popliteal Artery Aneurysm (PAA)
NCT02462876
Evaluation of the 25 Centimeter (cm) GORE® VIABAHN® Endoprosthesis
NCT01263665
GORE VIABAHN Endoprosthesis With Heparin Bioactive Surface in the Treatment of SFA Obstructive Disease (VIPER)
NCT00541307
Evaluation of GORE® VIABAHN® Endoprosthesis for Popliteal Artery Aneurysm
NCT01902888
GORE VIABAHN Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise AV Grafts in Hemodialysis
NCT00737672
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
GORE® VIABAHN® Endoprosthesis
Participants with symptomatic peripheral arterial disease in superficial femoral artery lesions.
GORE® VIABAHN® Endoprosthesis
Participants receiving the GORE® VIABAHN® Endoprosthesis
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
GORE® VIABAHN® Endoprosthesis
Participants receiving the GORE® VIABAHN® Endoprosthesis
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
W.L.Gore & Associates
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Kansai Rousai
Amagasaki, Hyōgo, Japan
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
JPS 16-03
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.