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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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Bioflow-VII New Enrollment PAS


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General
Study Status Progress Adequate
Application Number /
Requirement Number
P170030 / PAS001
Date Original Protocol Accepted 11/12/2019
Date Current Protocol Accepted 10/30/2020
Study Name Bioflow-VII New Enrollment PAS
Device Name ORSIRO Sirolimus Eluting Coronary Stent System
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, Adult: >21
Detailed Study Protocol Parameters
Study Objectives The BIOFLOW-VII study is a prospective, multi-center, single-arm study to confirm that the clinical performance of the Orsiro stent in a realworld
setting is similar to the clinical performance observed for Orsiro in the BIOFLOW-V IDE pivotal trial. Subjects who undergo percutaneous
coronary intervention (PCI) with a placed Orsiro stent within the prior 24 hours will be screened per the protocol inclusion and exclusion criteria
to achieve the desired evaluable subject counts (N=500) for the primary endpoint. The study will enroll subjects at up to 50 sites in the US. The
primary endpoint will evaluate the rate of 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).

Subjects may have received treatment of up to three target lesions in up to two separate target vessels (e.g., two target lesions in one vessel and
one target lesion in a separate vessel). The target lesion(s) must have been de novo or restenotic (PTCA only) atherosclerotic lesion(s) of less than or equal to 36 mm in length in native coronary artery(ies), with a reference vessel diameter of 2.25–4.0 mm. All lesions treated during a single index
procedure must meet target lesion criteria.
Study Population 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

Key Study Endpoints Primary Endpoints
The primary endpoint will evaluate the rate of 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 (TLF).

Secondary Endpoint:
Secondary endpoints measured in-hospital and at 6 months, 12 months, 2 years, and 3 years after the index procedure include:
TLR rate
TLF rate (primary endpoint at 12 months)
Target vessel revascularization (TVR) rate
Target vessel failure (TVF) rate
MI (Q-wave and non–Q-wave) rate
Cardiac death rate
Non-cardiac death rate
All death rate
Cardiac death or MI rate
All death or MI rate
All death/MI/TVR rate
Stent thrombosis rates (by Academic Research Consortium [ARC] definitions)
Follow-up Visits and Length of Follow-up 5 years
Interim or Final Data Summary
Interim Results Due to the early stage of the study, no interpretation, or conclusions regarding the overall safety of the study can be drawn.
Actual Number of Patients Enrolled 556
Actual Number of Sites Enrolled 31
Patient Follow-up Rate 98.01%
Study Strengths & Weaknesses This is a prospective, multi-center, single-arm study 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.


Bioflow-VII New Enrollment PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 08/23/2019 08/21/2019 On Time
1 year report 02/22/2020 02/21/2020 On Time
18 month report 08/22/2020 08/21/2020 On Time
2 year report 02/22/2021 02/22/2021 On Time
3 year report 02/22/2022 02/22/2022 On Time
4 year report 02/22/2023    


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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