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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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Continued Follow-up of the IDE Study Subjects


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General
Study Status Study Pending
Application Number /
Requirement Number
H230007 / PAS001
Date Original Protocol Accepted 12/04/2024
Date Current Protocol Accepted  
Study Name Continued Follow-up of the IDE Study Subjects
Device Name AMDS Hybrid Prosthesis
Clinical Trial Number(s) NCT03035643 NCT03397251 NCT05174767 
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives Prospective, non-randomized, non-blinded, single-arm, multicenter interventional study to assess continued follow-up of IDE subjects. To assess the safety and effectiveness of AMDS to treat patients with acute DeBakey type I dissection with evidence of radiographic and/or clinical malperfusion, through open surgical repair.
Study Population Patients with acute DeBakey Type I aortic dissection presenting with radiographic and/or clinical evidence of organ malperfusion, who meet all of the selection criteria.
Sample Size 93 patients in the pivotal study cohort
Key Study Endpoints The co-primary endpoints for the primary cohort are the following event rates at 30-days:
1. Patients experiencing at least one of the following MAEs:
• All-cause mortality (ACM)
• New disabling stroke
• New onset renal failure requiring dialysis
• Myocardial infarction (MI)
2. Patients with DANE documented by the independent Core Lab on a post-operative CTA
Key secondary endpoints:
• Mortality
• Additional Aortic Procedures
• Device Related Events
• Major Adverse Events
• Remodeling in the treated aortic segmented
Follow-up Visits and Length of Follow-up 60 months


Continued Follow-up of the IDE Study Subjects Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 12/04/2025    
2 year report 12/04/2026    
3 year report 12/04/2027    
4 year report 12/03/2028    
5 year report 12/03/2029    


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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