The GOREĀ® VIABAHNĀ® FORTEGRA Venous Stent IVC Study (NCT05409976) | Clinical Trial Compass
Active ā Not RecruitingNot Applicable
The GOREĀ® VIABAHNĀ® FORTEGRA Venous Stent IVC Study
United States136 participantsStarted 2022-10-25
Plain-language summary
This study is a prospective, multicenter, non-randomized, single-arm study to evaluate the performance, safety, and efficacy of the GOREĀ® VIABAHNĀ® FORTEGRA Venous Stent (formerly known as GOREĀ® VIAFORT Vascular Stent) for treatment of symptomatic inferior vena cava obstruction with or without combined iliofemoral obstruction in adult patients.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Preoperative Inclusion Criteria:
* Patient is at least 18 years of age.
* Patient is willing and able to comply with all follow-up evaluations as well as any required medication or compression regimen.
* Patient is able to provide informed consent.
* One of the following: Clinical severity class of CEAP 'C' classification ā„3 or rVCSS pain score ā„2.
* Intention to treat the target areas with only the GOREĀ® VIAFORT Vascular Stent.
* Estimated life expectancy ā„1 year.
* Patient is ambulatory (use of assistive walking device such as a cane or walker is acceptable).
* Patient has adequate inflow to the target lesion(s), per investigator/sub-investigator discretion, involving at least a patent femoral or deep femoral vein.
Preoperative Exclusion Criteria:
* Patient is a pregnant or breastfeeding woman, a woman planning to become pregnant through the 12-month visit, or a woman who is unwilling to practice an acceptable method of preventing pregnancy through the 12-month visit.
* Patient has clinically significant (e.g., symptoms of chest pain, hemoptysis, dyspnea, hypoxia, etc.) pulmonary embolism (confirmed via Computed Tomography Angiography) at the time of enrollment.
* Patient has a known uncorrectable bleeding diathesis or active coagulopathy meeting the following definitions: uncorrected INR\>2 (not as a result of warfarin or DOAC therapy), OR platelet count \<50,000 or \>1,000,000 cells/mm3, OR white blood cell count \<3,000 or \>12,500 cells/mm3.
* Patient has impaired reā¦
What they're measuring
1
Initial Subject Analysis Population: Percentage of Subjects With Freedom From the Composite Endpoint of Effectiveness and Safety Events
Timeframe: 12 months
2
Global Analysis Population: Percentage of Subjects With Freedom From the Composite Endpoint of Effectiveness and Safety Events