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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
Interim or Final Data Summary
Interim Safety Information Freedom from amputation of the target limb (above the knee), clinically driven TVR, clinically driven TLR and survival at 24 months (750 days) was 94.4%, 73.1%, 73.6% and 78.0% respectively.
Actual Number of Patients Enrolled A total of 233 subjects were enrolled in the study; 205 subjects were available at 6 months for the continued follow-up study
Actual Number of Sites Enrolled 41 sites across the US and outside the US
Patient Follow-up Rate 83.6% (143/171) at 24months and 91.6% (120/131) at 36 months
Final Safety Findings Primary Safety and Effectiveness
The TOBA II BTK study met both its primary safety and effectiveness endpoints. The primary safety endpoint of major adverse limb events (MALE) plus perioperative death (POD) at 30
days) was 1.3% [95% confidence interval (CI): 0.3%, 3.8%] in the ITT group and 0.9% [95% CI: 0.1%, 3.4%] in the PP group, compared to the 12% performance goal (PG).
The primary effectiveness endpoint of freedom from major adverse limb events (MALE) at 6 months +
perioperative death (POD) at 30 days) was 95.7% (95% CI: 91.9%,97.8%) in the intent to treat (ITT)
group and 95.9% [95% CI:92.0%,98.0%] in the per protocol population compared to 74% PG.
Secondary Endpoints
Tacked Segment Patency and Assisted Tacked Segment Patency at 12 months in ITT patients was 76.9% [95% CI :71.8%, 81.9%] each.
Secondary Tacked Segment Patency and Target Segment PSVR patency at 12 months in ITT patients was 87.6% [95% CI: 83.4%,91.7%) and 63.7% [95% CI: 57.8%,69.6%] respectively.
Tack embolization, migration or fracture at 12 months in ITT patients was 0.0% (0/146) [95% CI: 0.0%,2.5%] for each event.
The Kaplan Meier (KM) freedom from amputation of the target limb in ITT patients was at 36 months 95% [95% CI: 91.8%, 98.3%].
The KM freedom from survival at 36 months in ITT patients was 66.0% [95% CI: 58.7%, 73.3%]. A total of 64 patients died in the study. Sixty-three (63) of the 64 deaths were adjudicated by the Clinical Events Committee (CEC) to be unrelated to the study procedure and one (1) was adjudicated to be unknown. All 64 deaths were adjudicated by the CEC to be unrelated to the device.
Freedom from clinically driven target vessel revascularization in ITT patients at 36 months was 67.4% with 95% confidence interval (59.6%, 75.1%).
The KM freedom from clinically driven target lesion revascularization in ITT patients at 36 months was 69.6% [ 95% CI: 62.6%, 76.7%].
Freedom from major adverse limb events (MALE) plus perioperative death (POD) in ITT patients at 36 months was 91.6% [95 % CI: 87.6%, 95.6%].
Significant improvement in measured Rutherford class occurred in ITT patients from baseline to 12, 24, and 36 months (p<0.0001).
Significant positive changes in measured ABI and TBI in the target limb occurred in ITT patients from baseline to 12, 24, and 36 months (p<0.0001).
Significant improvement in wound grade occurred in ITT patients from baseline to 12, 24 and 36 months (P<0.0001).
Significant improvement occurred in foot infection grade in ITT patients from baseline to 12 months (0.0119), 24 months (<0.0001 and 36 months (P=0.0002).
Significant positive changes occurred in EQ-VAS score in ITT patients from baseline to 12 months (p=0.0004), 24 months (p=0.0035) and 36 months (p=0.0178) and Walking Impairment Questionnaire (overall) occurred from baseline to 12, 24, and 36 months (p < 0.0001).
No unanticipated device effect occurred in the study.
Study Strengths & Weaknesses The study met both safety and effectiveness endpoints. However, this was not a randomized trial. The continued follow-study results were not evaluated with formal hypothesis testing.
Recommendations for Labeling Changes Labeling change is recommended to reflect the long-term results of the continued 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 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 10/07/2021 On Time
2 year report 04/10/2022 04/08/2022 On Time
final report 06/28/2022 06/15/2022 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

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