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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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Cont F/u of the RIVER Trial


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General
Study Status Study Pending
Application Number /
Requirement Number		 H230002 / PAS001
Date Original Protocol Accepted 03/30/2026
Date Current Protocol Accepted 03/30/2026
Study Name Cont F/u of the RIVER Trial
Device Name River Stent System™
Clinical Trial Number(s) NCT03556085 
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Historical Control
Analysis Type Descriptive
Study Population Transit.Adolescent B(as adults): 18 yrs < 22 yrs, Adult: At least 22 yrs
Detailed Study Protocol Parameters
Study Objectives Continued follow-up of premarket cohort.
Study Population All living patients enrolled under “The RIVER Trial.” The RIVER Trial enrolled patients with idiopathic intracranial hypertension (IIH) who failed medical therapy, had a significant stenosis of the venous sinus (> 50% stenosis and pressure gradient greater than or equal to 8 mmHg), and had an upstream venous sinus diameter between 5 mm and 8.5 mm. Patients also had severe headache or vision loss at the time of study enrollment.
Sample Size 39 patients were implanted with the River Stent System in “The RIVER Trial.”
Key Study Endpoints Long-term follow-up data collected according to the IDE protocol will be used to provide safety and probable benefit information on the durability and safety of treatment using the River Stent System. As stipulated in the IDE protocol, follow-up assessments will include adverse event assessment, contrast enhanced magnetic resonance venography of the stented vessel for absence of significant stenosis or new stenosis, and clinically relevant improvement in the main clinical outcome per specific inclusion criteria for headache or ophthalmic enrollment criteria in “The RIVER Trial.”
Follow-up Visits and Length of Follow-up 5 years


Cont F/u of the RIVER Trial Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 09/28/2026    
1 year report 03/30/2027    
2 year report 03/29/2028    
3 year report 03/29/2029    
4 year report 03/29/2030    


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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