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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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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AVeVA Continued F/U Post-Approval Study


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General
Study Status Completed
Application Number P170042 / PAS001
Study Name AVeVA Continued F/U Post-Approval Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The purpose of the AVeVA study is to evaluate the long-term safety and effectiveness of the Covera Vascular Covered Stent. It is a prospective, multi-center, non-randomized, single-arm clinical study and involves continued follow-up of the premarket cohort.
Study Population Description The study population is patients dialyzing with an AV graft that have a stenoses at the venous anastomosis.
Sample Size A total of 110 subjects are enrolled in the study.
Data Collection Clinical outcomes at 12, 18, and 24 months will include target lesion primary patency, access circuit primary patency, secondary patient, total number of target lesion reinterventions and access circuit reinterventions, index of patency function, index of patency function – target lesion, and rate of device and procedure related adverse events.
Follow-up Visits and Length of Follow-up 2 years
Interim or Final Data Summary
Actual Number of Patients Enrolled 110 Subjects
Actual Number of Sites Enrolled 20 sites
Patient Follow-up Rate 68.2% (75/110) at 24 months; 24.5% (27/110) of subject discontinuation prior to 24-month follow-up was due to death.
Final Safety Findings Primary Safety

The primary safety endpoint for the pivotal trial was freedom from any adverse event(s) that required additional reintervention, in-patient hospitalization/prolongation or death through 30 days post index procedure. The primary safety endpoint for superiority to the

performance goal (PG) of 88% Study was met. The proportion of subjects free from primary safety events was 96.4% (106/110) vs. 88% PG [90% CI: 91.9, 98.7] (p-value = 0.0021).
Final Effect Findings The primary effectiveness endpoint for the pivotal study was Target Lesion Primary Patency (TLPP) through 6 months post-index procedure. The primary effectiveness endpoint for superiority to the performance goal (PG) of 40 % was met. The TLPP at 6 months was 70.3% (71/101), vs. 40% PG (p-value <0.0001).

Secondary Endpoints

TLPP at 12, 18 and 24 months was 50.5% (46/91), 38.4% (33/86) and 30.1% (25/83), respectively.

Access Circuit Primary Patency (ACPP) at 12, 18 and 24 months was 14.4% (14/97), 7.4% (7/94) and 4.3% (4/94), respectively.

The total number of AV access circuit reinterventions to maintain access circuit patency circuit was 222, 284 and 333 for 12, 18 and 24 months, respectively. At 24 months that equated to an average of 3.58 reinterventions per subject.

The total number of target lesion reinterventions to maintain patency was 81, 100 and 116 for 12, 18 and 24 months, respectively. At 24 months that equated to an average of 1.55 reinterventions per subject.

The Index of patency function (IPF) evaluated at 12, 18 and 24 months provided an average of 144 days, 163 days and 178 days respectively between interventions to maintain access circuit patency.

The Index of patency function for target lesion patency (IPF-T) evaluated at 12, 18 and 24 months provided an average of 253 days, 326 days and 380 days, respectively between interventions to maintain target lesion patency.

Secondary patency was 85.4 % (76/89), 80% (64/80) and 73.6% (53/72) at 12, 18 and 24 months, respectively.

Proportion of subjects free from device- and/or procedure-related events at 12, 18 and 24 months was 88.5% (85/96), 87.5% (77/88) and 86.3% (69/80), respectively.
Study Strengths & Weaknesses Strength: The pivotal study met both superior tests for primary safety and primary effectiveness compared to the respective performance goals (event free primary safety at 30 days, 96.4% vs. 88% PG, p=0.0021; Primary effectiveness, TLPP at 6 months 70.3% vs. 40% PG, p<0.0001). Follow-up was achieved in 68.2% of subjects at 24 months. Approximately 25% (27/110) of subject discontinuation prior to 24 months was due to death. Study was conducted at US sites only.
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 on the label showing a summary of the post-approval study results (final endpoint results, follow-up rate etc.), strengths and limitations of

the PAS.


AVeVA Continued F/U Post-Approval Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
final report 11/27/2019 11/26/2019 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

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