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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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New Enrollment Study


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General
Study Status Progress Adequate
Application Number P170027 / PAS001
Date Current Protocol Accepted  
Study Name New Enrollment Study
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description To confirm the safety and effectiveness of SSO2 Therapy.

This is a prospective, open-label, randomized (1:1) study.

Subjects who present with anterior STEMI requiring stent placement in the proximal and/or mid LAD who meet all eligibility criteria and provide informed consent will be treated with PCI with stenting, and if successful and uncomplicated then immediately randomized to post-procedure infusion of SSO2 Therapy for a duration of 60 minutes or standard of care.
Study Population Description Qualifying anterior STEMI patients (1 mm or greater of ST elevation in 2 or more contiguous leads in V1-V4) successfully treated with PCI and stenting within 6 hours from time of symptom onset.
Sample Size Up to sixty (60) centers including up to 45 centers in the U.S. and no more than 15 centers outside the U.S.

A total of 434 patients randomized (1:1) to SSO2 Therapy (Treatment group) or Standard of Care (Control group) i.e., 217 SSO2 Therapy: 217 Control. A minimum of 50% of study subjects will be enrolled in the US and the maximum per site enrollment is 40 subjects.

The safety sample size is based on the following assumptions:

1:1 randomization between SSO2 Therapy and control arms,

1-year NACE of 18% in SS02 and control patients,

5% loss to follow-up at 1-year,

1-sided non-inferiority test (Farrington-Manning),

Non-inferiority margin of 9.5%,

5% type I error and 80% power

Based on the assumptions above, a total sample size of 412 subjects (206 per group) will provide 80% power to evaluate primary safety, which is increased to 434 subjects (217 per group to account for 5% loss to follow-up.

The effectiveness assumptions are as follows:

27.1% infarct size at 2-7 days in the standard therapy group.

SSO2 Therapy group effect size = 25% relative reduction in 2-7day infarct size

Standard deviation of 16.1% in both treatment arms

Loss to follow-up or missing measurements = 25%

Type I Error = 5% (two-sided)

A total of 324 subjects (162 per group) are needed to achieve 96.6% power for testing the superiority of the SSO2 arm compared to the control arm using a two- sample t-test.
Data Collection Primary Safety endpoint is the 1-year rate of Net Adverse Clinical Events (NACE).

The composite NACE endpoint includes hierarchical total of death (all-cause), reinfarction, target vessel revascularization (ischemia driven), TIMI major bleeding or minor bleeding, New onset heart failure or re-hospitalization for heart failure and Stent thrombosis (ARC definite or probable).

The safety endpoint events will be adjudicated and classified by an independent Clinical Events Committee (CEC).

Primary effectiveness endpoint is the cardiac MRI endpoint of median infarct size (% of total left ventricle (LV) mass) at 2-7 days.

The major powered secondary endpoint is a hierarchical composite of all-cause mortality within 1 year, rehospitalization for heart failure within 1 year, and infarct size measured by cardiac MRI within 2-7 days after PCI.

Additional Non-Powered Endpoints:

MRI Endpoints-

Microvascular obstruction (2-7 days)

Left ventricular ejection fraction (2-7days, and 6 months)

Left ventricular end diastolic volume and volume index (2-7 days, and 6 months)

Left ventricular end systolic volume and volume index (2-7 days, and 6 months)

Change from 2-7 days to 6 months in MRI endpoints:

Infarct size

Left ventricular ejection fraction

Left ventricular end diastolic volume and volume index

Left ventricular end systolic volume and volume index

30-day, 6-month, and 1-year clinical endpoints

Death

Rehospitalization

Reinfarction

Revascularization

Target Lesion Failure

Stent Thrombosis
Follow-up Visits and Length of Follow-up 12 months



New Enrollment Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 10/01/2019 10/24/2019 Overdue/Received
one year report 04/01/2020 04/02/2020 Overdue/Received
18 month report 09/30/2020 09/28/2020 On Time
two year report 04/01/2021 03/30/2021 On Time
30 month report 10/01/2021    
three year report 04/01/2022    
four year report 04/01/2023    


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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