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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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ORSIRO PAS


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General
Study Status Protocol Pending
Application Number P170030 / PAS001
Date Current Protocol Accepted  
Study Name ORSIRO PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs
Detailed Study Protocol Parameters
Study Design Description BIOFLOW VII- to confirm that the clinical performance of the Orsiro stent in a real-world setting is similar to the clinical performance observed for Orsiro in the BIOFLOW-V IDE pivotal trial.



A prospective, multi-center, single-arm study



Study Population Description Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Sample Size A total of 556 subjects will be enrolled to achieve 500 evaluable subjects at 1 year. Subjects will be enrolled at up to 50 clinical sites. It is estimated that no more than 20% of the projected total subjects (approximately 111 subjects) will be enrolled at single site.



Sample Size Assumption are as follows:



Performance goal: 9.0%

Target Orsiro TLF rate: 4.0%

Statistical power: 80%

Significance level: 1-sided 0.025

Evaluable sample size – 201 subjects (unadjusted).

Per FDA recommendation- 500 (adjusted)

Adjusted for 10% attrition - 556



Data Collection Primary Endpoint

Target lesion failure (TLF) at 1-year post-index procedure.



TLF is defined as a composite of cardiac death, target vessel myocardial infarction (MI), or clinically-driven target lesion

revascularization (TLR).



Secondary endpoints

To be evaluated prior to discharge, at 1 month, 1 year, and annually thereafter through 5 years follow-up are

All-cause death.

Myocardial infarction (MI).

Cardiac death or MI.

Major Adverse Cardiovascular Events (MACE) and individual MACE components (MACE: composite of allcause death, Q-wave or non–Q-wave MI, and any clinically-driven TLR).

TLF (evaluated at 2, 3, 4, and 5 years) and individual TLF components (TLF: composite of cardiac death, target vessel Q-wave or non–Q-wave MI, and clinically-driven TLR).

Target Vessel Failure (TVF) and individual TVF components (TVF: composite of cardiac death, target vessel Q-wave or non–Q-wave MI, and any clinicallydriven TVR).

Stent thrombosis (definite, definite/probable, probable) according to Academic Research Consortium (ARC) criteria for acute, subacute, late, very late and cumulative stent thrombosis.



Follow-up Visits and Length of Follow-up 5 years


ORSIRO PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 08/23/2019 08/21/2019 On Time
one year report 02/22/2020    
18 month report 08/22/2020    
two year report 02/21/2021    
three year report 02/21/2022    
four year report 02/21/2023    


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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