f Post-Approval Studies (PAS) Database
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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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ABSORB IV Post-Approval Study

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Study Status Completed
Application Number /
Requirement Number
P150023 / PAS001
Study Name 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 Objectives 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 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
Key Study Endpoints 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
Interim or Final Data Summary
Actual Number of Patients Enrolled 2604
Actual Number of Sites Enrolled 147
Patient Follow-up Rate 85.9%
Final Safety Findings The ABSORB IV trial met its primary endpoint of non-inferiority of Absorb BVS compared to XIENCE in target lesion failure (TLF) at 30 days, with rates of 5.0% in the Absorb BVS arm and 3.7% in the XIENCE arm (non-inferiority p-value = 0.0244) in the Intent-To-Treat population. A pre-specified secondary analysis showed that the primary endpoint was also met in the As-Treated population, where 30-day TLF rates were 4.6% and 3.7% for Absorb BVS and XIENCE, respectively, with a non-inferiority At 5-years post-procedure, the rates of hierarchical composite adjudicated endpoints DMR (All Death, All MI, All Revascularization), TVF (Target Vessel Failure), MACE (Major Adverse Cardiac Event), and TLF (Target Lesion Failure) were 26.1%, 22.0%, 19.6%, and 18.2% for the Absorb BVS arm, respectively, and 23.7%, 20.0%, 17.3% and 15.0% for the XIENCE arm, respectively. Of the above mentioned hierarchical composite endpoints, results showed that TLF was statistically significant in the Absorb BVS arm compared to the XIENCE arm through 5 years, while DMR, TVF, and MACE were not statistically significant between study arms through 5 years.
Final Effect Findings Results of the landmark analyses for 0-3 years and 3-5 years, and 0-4 years and 4-5 years reinforce the difference in event rates for TLF, ST, TV-MI, and ID-TLR between Absorb BVS and XIENCE arms during the earlier stages of follow-up up to 3 years. Importantly, these event rates began to steadily decline after 3 years and eventually flattened out for the Absorb arm. Between 4 and 5 years, all event rates (TLF, ST, TV-MI and ID-TLR) were numerically lower for Absorb BVS, compared to the XIENCE arm. The trend of the results in the Absorb BVS arm after 3 years, such as a lower rate of events including TLF, and scaffold thrombosis compared to that in subjects with XIENCE is consistent with the expectation that no permanent implant is left in the artery around that time period after Absorb BVS treatment.
Study Strengths & Weaknesses This was a randomized, controlled trial that met its primary endpoint. However, the trial demographics were not diverse with respect to race and sez, with a large percent of the subjects being White and/or male.
Recommendations for Labeling Changes This device is no longer marketed by the company; therefore, a labeling change was not recommended.

ABSORB IV Post-Approval Study Reporting Schedule

Reporting Schedule
Date Due
FDA Receipt
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
interim report 12/05/2017 12/05/2017 On Time
Interim Report 12/06/2017 12/06/2017 On Time
18 month report 01/03/2018 12/18/2017 On Time
two year report 07/05/2018 07/02/2018 On Time
interim report 11/29/2018 11/29/2018 On Time
interim report 11/29/2018 11/29/2018 On Time
three year report 07/05/2019 07/03/2019 On Time
interim report 11/13/2019 11/13/2019 On Time
5 year report 11/13/2019 11/13/2019 On Time
3 year interim report 11/15/2019 11/15/2019 On Time
4 year report 07/04/2020 06/30/2020 On Time
3 year report 11/14/2020 11/04/2020 On Time
5 year report 07/04/2021 07/01/2021 On Time
interim report 10/18/2021 10/18/2021 On Time
final report 11/04/2022 10/28/2022 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

Additional Resources