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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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ODE Lead-VBX FLEX Continued f/u Study


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General
Study Status Progress Adequate
Application Number P160021 / PAS001
Study Name ODE Lead-VBX FLEX Continued f/u Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The objective of this post approval study (VBX FLEX Continued Follow-Up Study) is to evaluate the long term safety and effectiveness of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis for treatment of iliac arterial occlusive disease. This study is a prospective, single-armed, multi-center follow-up of the BES 10-07 pivotal study (G120232).
Study Population Description The study population included symptomatic (Rutherford Category 2-4) patients with angiographic confirmation of either de novo or restenotic unilateral or bilateral occlusive disease in the common and/or external iliac arteries, with a total treated lesion length of less than or equal to 110 mm and vessel diameters between approximately 5 mm and 13 mm. Patients were included who presented with up to two discrete lesions requiring treatment, either one lesion per side for patients presenting with bilateral disease, or two lesions on the same side. All subjects could be treated with up to three GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis. Eligible patients in the study included those presenting with tortuous iliacs, severe lesion calcification, total occlusions, and those determined to need direct stenting (pre-dilatation optional) and/or kissing stent treatment at the aortic bifurcation.
Sample Size All 133 remaining subjects (7 subjects have discontinued the study) of the 140 original study subjects enrolled from 26 sites in U.S. and 1 site in New Zealand.
Data Collection Primary Endpoint:

Freedom from target lesion revascularization at 36 months.

Target lesion revascularization is defined as revascularization occurring within the treated segment(s) by means of a percutaneous vascular intervention, surgical bypass, thrombolysis, or other invasive means.



Secondary Endpoints:

Freedom from target vessel revascularization (TVR) at 12, 24 and 36 months.

Freedom from target lesion revascularization (TLR) at 12 and 24 months.

Primary patency at 12 months.

Primary assisted patency at 12 months.

Secondary patency at 12 months.

Change in Rutherford category from pre-procedure at 12, 24 and 36 months.

Change in resting Ankle-Brachial Index (ABI) or Toe Brachial Index (TBI) from pre-procedure at 12, 24 and 36 months.

Change in functional status from pre-procedure based on EQ-5D at 12, 24 and 36 months.

Change in functional status from pre-procedure based on Walking Impairment Questionnaire (WIQ) at 12, 24 and 36 months.

Serious adverse events at 12, 24 and 36 months.

Follow-up Visits and Length of Follow-up 36 months

Annual (12, 24, 36 months)


ODE Lead-VBX FLEX Continued f/u Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 07/28/2017 07/27/2017 On Time
one year report 01/27/2018    
18 month report 07/28/2018    
two year report 01/27/2019    
three year report 01/27/2020    
four year report 01/26/2021    
five year report 01/26/2022    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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