This study is a prospective, multicenter, non-randomized, single-arm 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 inferior vena cava obstruction with or without combined iliofemoral obstruction in adult patients.
A maximum of 35 clinical investigative sites across the U.S., Europe, Australia, and New Zealand will participate in this study. One hundred and eleven subjects are intended to be implanted with the GORE® VIABAHN® FORTEGRA Venous Stent (formerly known as GORE® VIAFORT Vascular Stent) in this study, with a limit of 22 treated subjects per site and a minimum of 45 patients treated within the United States. Subjects will be evaluated through hospital discharge and return for follow-up visits at 1, 6, 12, 24, 36, 48, and 60 months post-treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
112
Treatment of symptomatic IVC obstruction with or without combined iliofemoral obstruction with the GORE® VIAFORT Vascular Stent.
Stanford University School of Medicine
Stanford, California, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Northwestern
Chicago, Illinois, United States
University of Michigan
Ann Arbor, Michigan, United States
Mount Sinai Medical Center
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
Atrium Health-Sanger Heart and Vascular Institute
Charlotte, North Carolina, United States
Sentara
Norfolk, Virginia, United States
Flinders Medical Centre
Adelaide, South Australia, Australia
Universitätsklinikum Aachen
Aachen, Germany
...and 7 more locations
Composite of efficacy and safety events
Composite primary endpoint consisting of freedom from the following: * Loss of primary patency through 12-month follow-up * 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 days
Time frame: 12 months
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
Time frame: 60 months
Number of subjects with secondary patency as confirmed by imaging and adverse events
Number of subjects with freedom from permanent loss of blood flow through the device, regardless of reintervention.
Time frame: 60 months
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.
Time frame: 60 months
Number of subjects with device fracture as confirmed with imaging
Number of subjects with device fracture as confirmed with imaging.
Time frame: 60 months
Number of subjects with stent embolization as confirmed with imaging
Number of subjects with stent embolization as confirmed with imaging.
Time frame: 12 months
Number of subjects with device- or procedure-related death
Number of subjects with device- or 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 confirmed via Computed Tomography Angiography through 30 days.
Time frame: 30 days
Number of subjects with device- or procedure-related vascular injury as confirmed with adverse events
Number of subjects with device- or procedure-related vascular injury through 30 days requiring surgical or endovascular intervention.
Time frame: 30 days
Number of subjects with device- or procedure-related major bleeding events as confirmed with adverse events
Number of subjects with device- or procedure-related major bleeding events through 30 days.
Time frame: 30 days
Revised Venous Clinical Severity Scale (rVCSS)
Change in Revised Venous Clinical Severity Scale (rVCSS) Measurement through 60-month follow-up compared to baseline prior to treatment. Note: The rVCSS scale ranges from 0 to 30, with higher scores reflecting worse symptoms.
Time frame: 60 months
Revised Venous Clinical Severity Scale (rVCSS) Pain
Change in Revised Venous Clinical Severity Scale (rVCSS) Pain Measurement through 60-month follow-up compared to baseline prior to treatment. Note: The rVCSS Pain scale ranges from 0 to 3, with higher scores reflecting worse pain.
Time frame: 60 months
Venous Insufficiency Epidemiological and Economic Study - Quality of Life/Symptoms (VEINES-QOL/Sym) VEINES-QOL/Sym
Change in Venous Insufficiency Epidemiological and Economic Study - Quality of Life/Symptoms (VEINES-QOL/Sym) Measurement through 60-month follow-up compared to baseline prior to treatment.
Time frame: 60 months
Villalta
Change in Villalta Measurement through 60-month follow-up compared to baseline prior to treatment.
Time frame: 60 months
5 Level EuroQol-5 Dimension (EQ-5D-5L)
Change in 5 Level EuroQol-5 Dimension (EQ-5D-5L) Measurement through 60-month follow-up compared to baseline prior to treatment.
Time frame: 60 months
Technical success
Number of subjects with successful delivery and deployment of the stent to the intended location, and removal of delivery system.
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 venogram.
Time frame: Index procedure (post-op day 0)
Procedural success
Number of subjects with lesion success and the absence of major adverse events (i.e., stent embolization, device- or procedure-related death, clinically significant pulmonary embolism, device- or procedure-related vascular injury requiring surgical or endovascular intervention, and device- or procedure-related major bleeding) prior to discharge.
Time frame: Index procedure through hospital discharge (discharge estimated as up to 30 days post-treatment)
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