Post-Approval Studies (PAS) Database

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.

Learn more...

VNS 21-05 Continued follow-up study

General
Study Status	Study Pending
Application Number / Requirement Number	P250017 / PAS001
Date Original Protocol Accepted	12/19/2025
Date Current Protocol Accepted	12/19/2025
Study Name	VNS 21-05 Continued follow-up study
Device Name	GORE® VIABAHN® FORTEGRA Venous Stent
Clinical Trial Number(s)	NCT05409976 NCT05489588
General Study Protocol Parameters
Study Design	Prospective Cohort Study
Data Source	New Data Collection
Comparison Group	No 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	The study will evaluate the long-term safety and effectiveness of the Gore Viabahn FORTEGRA Venous Stent. The VNS 21-05 study is a prospective, multicenter, single arm trial. This PAS is continued follow-up of the premarket cohort.
Study Population	Adult patients (at least 18 years of age) with symptomatic unilateral iliofemoral venous obstruction. The population is expected to be 55% thrombotic and 45% non-thrombotic. Patients with malignant obstruction are excluded.
Sample Size	All 85 patients remaining in the study after premarket approval
Key Study Endpoints	Secondary Endpoints Primary patency, secondary patency, clinically driven target lesion revascularization (CD-TLR), stent occlusion and device fracture through 60-month follow-up. Improvement in rVCSS, rVCSS Pain, VEINES, Villalta, and EQ-5D-5L measurements through 60-month follow-up compared to pre-treatment baseline
Follow-up Visits and Length of Follow-up	5 years

VNS 21-05 Continued follow-up study Reporting Schedule

Reporting Schedule	Report Date Due	FDA Receipt Date	Applicant's Reporting Status
1 year report	12/19/2026
2 year report	12/19/2027
3 year report	12/18/2028
4 year report	12/18/2029

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

---

• Guidance Document: "Procedures for Handling Post-Approval Studies Imposed by PMA Order"
• PAS Program Background