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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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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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TOBA II BTK Continued Follow-up Study


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General
Study Status Progress Adequate
Application Number P190027 / PAS001
Date Current Protocol Accepted  
Study Name TOBA II BTK Continued Follow-up Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description TOBA II BTK Continued Follow-Up Study. This study should be conducted per protocol CA 0137, Rev C (dated September 14, 2017). This study is a prospective, multi-center follow up of the TOBA II BTK pivotal study (G160144) that treated 233 subjects from 41 investigational sites. It will evaluate the long-term safety and effectiveness of the Tack Endovascular System® (4F, 1.5-4.5mm). All 205 remaining subjects, active at the end of the 6-month evaluation, will continue to be followed annually through 36 months.

Study Population Description Continued follow-up of the IDE cohort
Sample Size 205 remaining IDE subjects, active at the end of the 6-month evaluation
Data Collection Follow-up at the 1, 2- and 3-year timepoints will include the following:



Rutherford Classification

Wound, Ischemia, and foot Infection (WIfI) grade

wound assessment

target limb resting ABI

EQ-5D-3L

Walking Impairment Questionnaire (WIQ)

major adverse event (MAE) occurrence

adverse event occurrence

review of concomitant medications (antiplatelets/anticoagulants).



Follow-up at the 1-year timepoint will also include duplex ultrasound (DUS) and X-ray assessment of implanted Tacks.

Follow-up Visits and Length of Follow-up 3 years post-procedure


TOBA II BTK Continued Follow-up Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 10/09/2020 10/09/2020 On Time
one year report 04/10/2021 04/09/2021 On Time
18 month report 10/09/2021    
two year report 04/10/2022    
three year report 04/10/2023    
four year report 04/09/2024    
five year report 04/09/2025    


Contact Us

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

Additional Resources

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