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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P180034 / PAS001 |
| Date Original Protocol Accepted |
04/11/2019
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| Date Current Protocol Accepted |
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| Study Name |
TOBA II Continued f/u Study
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| Device Name |
Tack Endovascular System (6F)
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
Objective Performance Criterion
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| Analysis Type |
Descriptive
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| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
Prospective, multi-center, single arm follow-up of the TOBA II pivotal study cohort studied under IDE G150029
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| Study Population |
Continued follow-up of the IDE cohort
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| Sample Size |
204 remaining IDE subjects, active at the end of the 1-year evaluation
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| Key Study Endpoints |
Safety: Freedom from MAE at 30days compared to PG
Effectiveness: Primary patency at 12months compared to PG
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| Follow-up Visits and Length of Follow-up |
3 years post-procedure
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| Interim or Final Data Summary |
| Interim Results |
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.
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| Actual Number of Patients Enrolled |
A total of 213 subjects were enrolled for the study.
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| Actual Number of Sites Enrolled |
Thirty-three (33) enrolling study sites in the United States and Austria
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| Patient Follow-up Rate |
78.4% (167/213) at 24 months and 71.8% (153/213) at 36 months.
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| 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.
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| 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.
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| 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.
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