• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

  • Print
  • Share
  • E-mail
-

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.

Learn more...


             

VBX FLEX Continued f/u Study


Suggest Enhancement / Report Issue | export reports to excelExport to Excel
General
Study Status Progress Adequate
Application Number P160021 / PAS001
Study Name 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)
Interim or Final Data Summary
Actual Number of Patients Enrolled 140 Intent-to-treat population (134 per-protocol population)
Actual Number of Sites Enrolled 27
Patient Follow-up Rate 133 (99.3%) at 30 days

107 (79.9%) at 36 months
Final Safety Findings The safety endpoint of this study is a composite of Major Adverse Events (MAEs). Key elements and findings include the following:

No device or procedure related deaths were reported within 30 days of the index procedure.

No MIs were reported within 30 days of the index procedure.

Three (3) cases of TLR were reported within 9 months of the index procedure.

No amputation above the metatarsals were reported within 9 months of the index procedure.
Final Effect Findings Key effectiveness endpoints and associated findings include the following:

Kaplan-Meier estimate of freedom from TLR (survival probability) is 91.2% at 36 months.

Kaplan-Meier estimate of freedom from clinically driven TLR (survival probability) is 98.1% at 36 months.

Kaplan-Meier estimate of freedom from TVR (survival probability) is 91.4% at 36 months.

Kaplan-Meier estimate of freedom from clinically driven TVR (survival probability) is 97.1% at 36 months.

Kaplan-Meier estimate of primary assisted patency (survival probability) is 99.0% at 12 months.

Change in Rutherford category from pre-procedure is 0.0% at 12 months, 1.0% at 24 months, and 0.0% at 36 months.

Improvement or maintenance in functional status from pre-procedure based on EQ-5D is at 87.7% at 12-months, 87.1% at 24-months, and

86.5% at 36 months

Median improvement in walking distance, walking speed, and stair climbing based on the Walking Impairment Questionnaire (WIQ) is

shown in the table below at 12, 24 and 36 months

Walking Impairment Questionnaire (WIQ)

Timepoint, months Walking Distance Walking Speed Stair Climbing

12 9 5 3

24 11 5 3

36 9 5 4
Study Strengths & Weaknesses The follow-up compliance and study deviations were within reasonable expectations.
Recommendations for Labeling Changes Additional information is available from these results that supplements information already contained in the publicly available SSED and labeling.

Therefore, labeling changes are recommended


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 01/30/2018 Overdue/Received
18 month report 07/28/2018 07/25/2018 On Time
two year report/final 01/27/2019 01/25/2019 On Time


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Related Links

-
-