This study is a prospective, multicenter, single-arm post-market clinical study to evaluate the GORE® VIABAHN® FORTEGRA Venous Stent in real-world use.
A maximum of 35 clinical investigative sites in the U.S. will participate in this study. One hundred and fifty subjects are intended to be implanted with the GORE® VIABAHN® FORTEGRA Venous Stent in this study, with a limit of 30 treated subjects per site. Subjects will be evaluated through hospital discharge and return for follow-up visits at 1, 6, 12, 24, and 36 months post-treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Treatment with the GORE® VIABAHN® FORTEGRA Venous Stent.
Primary effectiveness as assessed by primary patency
Rate of subjects with primary patency as confirmed by imaging and adverse events
Time frame: 12 months
Primary safety as assessed by SAEs
Rate of subjects with freedom from device- or index procedure-related SAEs
Time frame: 30 days
Rate of subjects with primary patency as confirmed by imaging and adverse events
Rate of subjects with freedom from both: * stent occlusion due to restenosis or thrombosis as confirmed with imaging, and * clinically driven target lesion revascularization as confirmed with imaging and adverse events
Time frame: 36 months
Rate of subjects with secondary patency as confirmed by imaging and site-reported device abandonment
Freedom from permanent loss of blood flow through the device, regardless of reintervention
Time frame: 36 months
Rate of subjects with clinically driven target lesion revascularization as confirmed by imaging and adverse events
Rate of subjects with Repeat endovascular procedures (e.g., PTA, stenting, thrombectomy/thrombolysis) to restore flow, performed within the margins of the study devices due to ≥50% restenosis of the target lesion as measured via imaging AND the failure to improve or recurrence of symptoms present at baseline, or the onset of new symptoms related to the target lesion
Time frame: 36 months
Number of subjects with stent embolization as confirmed by adverse events and imaging
Number of subjects with stent embolization
Time frame: 12 months
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Number of subjects with device- or index procedure-related death as confirmed with adverse events
Number of subjects with device- or index procedure-related death
Time frame: 30 days
Number of subjects with clinically significant pulmonary embolism as confirmed with imaging and adverse events
Number of subjects with clinically significant pulmonary embolism as confirmed via CTA
Time frame: 30 days
Number of subjects with device- or index procedure-related vascular injury as confirmed with adverse events
Number of subjects with device- or index procedure-related vascular injury requiring surgical or endovascular intervention
Time frame: 30 days
Number of subjects with device- or index procedure-related major bleeding events as confirmed with adverse events
Number of subjects with device- or index procedure-related major bleeding events
Time frame: 30 days
5 Level EuroQol-5 Dimension (EQ-5D-5L)
Change in 5 Level EuroQol-5 Dimension (EQ-5D-5L) Measurement through 36-month follow-up compared to baseline prior to treatment
Time frame: 36 months
Technical success
Number of subjects with successful delivery and deployment of the stent to the intended location
Time frame: Index procedure (post-op day 0)
Lesion success
Number of subjects with evidence of ≤50% residual stenosis at the conclusion of the index procedure as measured by IVUS or contrast angiography
Time frame: Index procedure (post-op day 0)