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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 Continued f/u Study


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General
Study Status Completed
Application Number P180034 / PAS001
Study Name TOBA II Continued f/u 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 Prospective, multi-center, single arm follow-up of the TOBA II pivotal study cohort studied under IDE G150029
Study Population Description Continued follow-up of the IDE cohort
Sample Size 204 remaining IDE subjects, active at the end of the 1-year evaluation
Data Collection Safety: Freedom from MAE at 30days compared to PG

Effectiveness: Primary patency at 12months compared to PG

Follow-up Visits and Length of Follow-up 3 years post-procedure
Interim or Final Data Summary
Interim Safety Information 24 months follow-up compliance does not raise concerns regarding study conduct and there are no major clinical concerns with the Post Approval Study data reported to date.
Actual Number of Patients Enrolled A total of 213 subjects were enrolled for the study.
Actual Number of Sites Enrolled Thirty-three (33) enrolling study sites in the United States and Austria
Patient Follow-up Rate 78.4% (167/213) at 24 months and 71.8% (153/213) at 36 months.
Final Safety Findings The primary safety endpoint (freedom from occurrence of any new-onset MAEs defined as index limb major amputation (above the ankle), clinically driven TLR, or all-cause death at 30 days) was 100% in both ITT and PP groups (95% lower CI: 98.6% (ITT), 98.5% (PP)), which met the 88% performance goal (p<0.0001).



Secondary Safety Results

A total of 15 deaths occurred. All deaths were adjudicated by the Clinical Events Committee (CEC) as unrelated to the study device or procedure. The Kaplan-Meier estimate of survival rate at 12, 24 and 36 months was 98.1%, 95.0% and 92.3% (95% CI: 87.5%, 95.3%), respectively.

There were 51 clinically driven target lesion revascularizations (CD-TLR) as adjudicated by the CEC.

The KM estimate of freedom from CD-TLR at the end of the 12-, 24- and 36-month windows was 84.5%, 78.2%, and 73.6%, respectively. The KM estimate of freedom from any TVR at the end 12-, 24- and 36 months was 83.0%, 74.1% and 69.5%, respectively in the ITT population.

KM estimate of freedom from major amputations through 36 months was 100%

No Unanticipated major adverse events (UMAEs) occurred within the study.
Final Effect Findings The primary efficacy endpoint (12- month primary patency) was 65.2% (95% lower CI: 57.9%) in the intent to treat (ITT) group and 65.9% (95% lower CI: 58.0%) in the per protocol (PP) group which were greater than the 52.7% performance goal (0.0008).

Secondary Effectiveness Results

Significant positive changes in Rutherford class occurred from baseline to 12, 24, and 36 months (p<0.0001).

Significant positive changes in measured ABI occurred from baseline to 12, 24, and 36 months (p<0.0001).

Significant (p<0.05) positive changes in the Peripheral Artery Questionnaire, EQVAS and Walking Impairment Questionnaire occurred from baseline to 12, 24, and 36 months.

No fracture or embolization was observed through 12 months post-procedure.

One migration was reported in 730 Tacks implanted in 184 subjects with 12-month x-ray data and was limited to 2.6 mm of movement; through 12 months this subject had no reported adverse events and the artery was patent.
Recommendations for Labeling Changes Labeling change is recommended to reflect the long-term results of the post approval study. The labeling change should include a new section in the label showing a summary of the post- approval study results (final endpoint results, follow-up rate etc.), strengths and limitations of the PAS.


TOBA II Continued f/u Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 10/10/2019 10/10/2019 On Time
one year report 04/10/2020 04/10/2020 On Time
18 month report 10/09/2020 10/09/2020 On Time
final report 04/10/2021 03/18/2021 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

Additional Resources

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