This study is a prospective, non-randomized, multicenter, single-arm, clinical study to evaluate the performance, safety and efficacy of the GORE® VIABAHN® FORTEGRA Venous Stent (formerly known as GORE® VIAFORT Vascular Stent) for treatment of symptomatic iliofemoral venous obstruction.
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 ≥3 or rVCSS pain score ≥2.
Patient has DVT in the target areas with symptom onset date greater than 14 days but less than or equal to 90 days prior to treatment.
Patient is a pregnant or breastfeeding woman, or a woman planning to become pregnant 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.
uncorrected INR>2 (not as a result of warfarin or DOAC therapy), OR
Single group
GORE® VIAFORT Vascular Stent
DeviceTreatment of unilateral symptomatic iliofemoral venous obstruction with the GORE® VIAFORT Vascular Stent.
Composite of safety events
Composite primary safety endpoint consisting of freedom from the following: * Stent embolization through 12-month follow-up * Device- or procedure-related death through 30 days * Clinically significant pulmonary embolism confirmed via Computed Tomography Angiography through 30 days * Device- or procedure-related vascular injury through 30 days requiring surgical or endovascular intervention * Device- or procedure-related major bleeding events through 30 day
Primary efficacy as assessed by primary patency
Rate of subjects with primary patency as confirmed by imaging and adverse events
Number of subjects with primary patency as confirmed by imaging and adverse events
Number 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
Number of subjects with secondary patency as confirmed by imaging and adverse events
Freedom from permanent loss of blood flow through the device, regardless of reintervention.
Number of subjects with clinically driven target lesion revascularization as confirmed by imaging and adverse events
Number of subjects with repeat endovascular procedures (e.g., PTA, stenting, thrombectomy/thrombolysis) to restore flow, performed within the margins of the investigational devices due to ≥50% restenosis of the target lesion as measured via imaging AND the failure to improve or recurrence of venous origin leg pain or venous edema related to the target lesion present at baseline, or the onset of new symptoms including venous origin pain and venous edema related to the target lesion.
Number of subjects with device fracture as confirmed with imaging
Number of subjects with device fracture as confirmed with imaging.
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