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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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ODE Lead ABSORB IV Post-Approval Study


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General
Study Status Progress Adequate
Application Number P150023 / PAS001
Study Name ODE Lead ABSORB IV Post-Approval Study
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 Design Description Study Objective

Evaluate the safety of the use of Absorb in a real-world setting following commercial physician training

Observe the effectiveness of commercial physician training on appropriate vessel sizing in the use of Absorb in a real-world setting



Study Design

Prospective, open-label, multi-center, single-arm, non-randomized trial designed to observe Absorb continued safety during commercial use in real world settings.

Study Population Description Full Analysis Set (FAS): All subjects registered in the study.

Absorb Only Population (AOP): Subjects who have had only Absorb study devices implanted.

Pooled Absorb Population (PAP): Subjects from the ABSORB Post-Approval Clinical Study and ABSORB IV trial. The ABSORB PAS is projected to enroll approximately 75% ABSORB IV-like subjects (approximately N=1500), this will be pooled with approximately N=1500 Absorb subjects from the ABSORB IV trial.

Sample Size Approximate 2000 subjects total
Data Collection Primary Endpoint

The powered primary endpoint of the ABSORB Post-Approval Study trial is the composite of cardiac death and myocardial infarction (CD/MI) at 1 year. MI is adjudicated per the Universal MI definition.



Major Secondary Endpoint

The major secondary endpoint is definite/probable scaffold thrombosis (per ARC definition) at 1 year.



Other Endpoints:



Commercial Training Assessment Endpoint (Angiographic Subgroup only)

Percentage of very small vessels*

Clinical Endpoints – evaluated in hospital and at each follow-up time point

¿ Component and Other Clinical Endpoints

Death (Cardiac, Non-Cardiac)

All Myocardial Infarction (All MI)

Target Lesion Revascularization (TLR)

Ischemia Driven TLR (ID-TLR)

Target Vessel Revascularization (TVR)

All coronary revascularization

Scaffold thrombosis (per ARC definition)

¿ Composite Endpoints

Death/All MI

Cardiac Death/All MI

Cardiac Death/All MI/TVR (Target Vessel Failure, TVF)

Cardiac Death/TV MI/ID-TLR (TLF)

Death/All MI/All revascularization



ODE Lead ABSORB IV Post-Approval Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 01/03/2017 12/21/2016 On Time
one year report 07/05/2017 07/05/2017 On Time
18 month report 01/03/2018    
two year report 07/05/2018    
three year report 07/05/2019    
four year report 07/04/2020    
five year report 07/04/2021    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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