The GORE® VIAFORT Vascular Stent Iliofemoral Study

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ClinicalTrials.gov Identifier: NCT05489588

Recruitment Status : Recruiting

First Posted : August 5, 2022

Last Update Posted : March 6, 2024

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Sponsor:

Information provided by (Responsible Party):

W.L.Gore & Associates

Study Description

Brief Summary:

This study is a prospective, non-randomized, multicenter, single-arm, clinical study to evaluate the performance, safety and efficacy of the GORE® VIAFORT Vascular Stent for treatment of symptomatic iliofemoral venous obstruction.

Condition or disease	Intervention/treatment	Phase
Venous Thromboses Venous Disease Venous Leg Ulcer Venous Stasis Venous Ulcer Venous Stenosis Venous Occlusion Vein Thrombosis Vein Occlusion Vein Disease	Device: GORE® VIAFORT Vascular Stent	Not Applicable

Detailed Description:

A maximum of 25 clinical sites across the U.S. will participate in the study. One hundred and sixty-five subjects are intended to be implanted with the GORE® VIAFORT Vascular Stent in this study, with a limit of 33 treated subjects per site. 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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	165 participants
Allocation:	N/A
Intervention Model:	Single Group Assignment
Intervention Model Description:	This study is a prospective, multicenter, non-randomized, single-arm study.
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Evaluation of the GORE® VIAFORT Vascular Stent for Treatment of Symptomatic Iliofemoral Venous Obstruction
Actual Study Start Date :	March 2, 2023
Estimated Primary Completion Date :	April 2025
Estimated Study Completion Date :	April 2029

Arms and Interventions

Arm	Intervention/treatment
Experimental: GORE® VIAFORT Vascular Stent GORE® VIAFORT Vascular Stent	Device: GORE® VIAFORT Vascular Stent Treatment of unilateral symptomatic iliofemoral venous obstruction with the GORE® VIAFORT Vascular Stent.

Outcome Measures

Primary Outcome Measures :

Composite of safety events [ Time Frame: 12 months (Stent Embolization) or 30 days (all other components) ]
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 [ Time Frame: 12 months ]
Rate of subjects with primary patency as confirmed by imaging and adverse events

Secondary Outcome Measures :

Number of subjects with primary patency as confirmed by imaging and adverse events [ Time Frame: 60 months ]
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 [ Time Frame: 60 months ]
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 [ Time Frame: 60 months ]
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 [ Time Frame: 60 months ]
Number of subjects with device fracture as confirmed with imaging.
Number of subjects with stent embolization as confirmed with imaging [ Time Frame: 12 months ]
Number of subjects with stent embolization as confirmed with imaging
Number of subjects with device- or procedure-related death [ Time Frame: 30 days ]
Number of subjects with device- or procedure-related death
Number of subjects with clinically significant pulmonary embolism as confirmed with imaging and adverse events [ Time Frame: 30 days ]
Number of subjects with clinically significant pulmonary embolism confirmed via Computed Tomography Angiography through 30 days.
Number of subjects with device- or procedure-related vascular injury as confirmed with adverse events [ Time Frame: 30 days ]
Number of subjects with device- or procedure-related vascular injury through 30 days requiring surgical or endovascular intervention.
Number of subjects with device- or procedure-related major bleeding events as confirmed with adverse events [ Time Frame: 30 days ]
Number of subjects with device- or procedure-related major bleeding events through 30 days.
Revised Venous Clinical Severity Scale (rVCSS) [ Time Frame: 60 months ]
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.
Revised Venous Clinical Severity Scale (rVCSS) Pain [ Time Frame: 60 months ]
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.
Venous Insufficiency Epidemiological and Economic Study - Quality of Life/Symptoms (VEINES-QOL/Sym) VEINES-QOL/Sym [ Time Frame: 60 months ]
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.
Villalta [ Time Frame: 60 months ]
Change in Villalta Measurement through 60-month follow-up compared to baseline prior to treatment.
5 Level EuroQol-5 Dimension (EQ-5D-5L) [ Time Frame: 60 months ]
Change in 5 Level EuroQol-5 Dimension (EQ-5D-5L) Measurement through 60-month follow-up compared to baseline prior to treatment.
Technical success [ Time Frame: Index procedure (post-op day 0) ]
Number of subjects with successful delivery and deployment of the stent to the intended location, and removal of delivery system.
Lesion success [ Time Frame: Index procedure (post-op day 0) ]
Number of subjects with evidence of ≤50% residual stenosis at the conclusion of the index procedure as measured by IVUS or venogram.
Procedural success [ Time Frame: Index procedure through hospital discharge (discharge estimated as up to 30 days post-treatment) ]
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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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 ≥3 or rVCSS pain score ≥2.
Intention to treat the target areas with only the GORE® VIAFORT Vascular Stent.
Estimated life expectancy ≥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.
Presence of non-malignant symptomatic unilateral iliofemoral venous obstruction.

Preoperative Exclusion Criteria:

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.
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 renal function (eGFR <30 mL/min/1.73m2) or is currently on dialysis.
Patient has uncorrected hemoglobin of <9 g/dL.
Patient has known history of antiphospholipid syndrome (APS) or patients with hypercoagulable states that are unwilling to take anticoagulant medications on a long-term basis.
Patient has known homozygous inherited coagulation defect or Protein C/S deficiency.
Patient has a planned surgical intervention (other than pre-stenting procedures such as thrombolysis or thrombectomy) within 30 days prior to or within 30 days after the planned study procedure.
Patient has had or requires open deep venous surgery in the target limb.
Patient is currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this treatment, in the opinion of the investigator/sub-investigator. Observational studies are permitted.
Patient has had a previous major (i.e., above the ankle) amputation of the target lower limb.
Patient has known sensitivity to device materials or contraindication to antiplatelets, thrombolytics, anticoagulants (including patients with known prior instances of Heparin Induced Thrombocytopenia type 2 (HIT-2)), or iodinated contrast.
Patient has had prior stenting or grafts in the target vessels.
Patient has a known or suspected active systemic infection at the time of the index procedure. Patients with a chronic infection (e.g., HIV, hepatitis C) that is well controlled under their current treatment regimen may be eligible.
Patient has known history of intravenous drug abuse within one year of treatment.
Patient has significant peripheral arterial disease (chronic Rutherford Type 2 or greater, acute Rutherford Type IIa or greater).
Patient has a BMI >40.
Patient is actively undergoing or plans to begin cancer treatment.

Intraoperative Inclusion Criteria:

Presence of non-malignant unilateral obstruction of the common femoral vein, external iliac vein, and/or common iliac vein defined as occlusion or at least 50% reduction in target vessel lumen as measured by procedural IVUS and venogram.
Patient can accommodate an appropriately sized GORE® VIAFORT Vascular Stent as per reference vessel diameter (see IFU), as determined by intraoperative IVUS post pre-dilation.
Patient must have appropriate access vessels to accommodate the delivery sheath for the selected device size.
Patient has adequate landing zones free from significant disease requiring treatment within the native vessels beyond the proximal and distal margins of the lesion.
Patient has adequate inflow to the target lesion(s), per investigator/sub-investigator discretion, involving at least a patent femoral or deep femoral vein.
Lesion can be traversed with a guidewire.
Disease involves only unilateral iliofemoral venous segments with intent to stent all affected iliofemoral segments. Patients with disease extending into the inferior vena cava or contra-lateral iliofemoral veins who are anticipated to require endovascular or surgical treatment within 12 months after investigational device implant will be excluded.
Patient does not have significant (i.e., >20% residual thrombosis) acute thrombus within the target stent area at the time of investigational device placement. Patients with acute thrombus within the target stent area must have thrombus successfully treated prior to investigational device placement. Successful thrombus treatment is defined as reestablishment of antegrade flow with ≤20% residual thrombosis as confirmed by IVUS and venogram, AND freedom from bleeding, vascular injury, or hemodynamically significant pulmonary embolism. After successful thrombus treatment, investigational device placement can occur within the same procedure.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05489588

Contacts

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Contact: Carl Conway	6175952277	cconway@wlgore.com
Contact: Leonard Resecker	62356520649287074940	lresecke@wlgore.com

Locations

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United States, California
Stanford University School of Medicine	Recruiting
Stanford, California, United States, 94305
Contact: Sharon Cardenas-Ledezma carshar@stanford.edu
Principal Investigator: Andrew Kesselman, MD
Sub-Investigator: Alex Vezeridis, MD
Sub-Investigator: Andrew Picel, MD
Sub-Investigator: William Kuo, MD
Sub-Investigator: Lawrence Hofmann, Md
United States, Connecticut
Vascular Care Group	Recruiting
Darien, Connecticut, United States, 06820
Contact: Liz Gagne 203-548-7860 ext 999 egagne@vascularbreakthroughs.com
Principal Investigator: Paul Gagne, MD
Sub-Investigator: Benjamin Chandler, MD
Sub-Investigator: Edward Arous, MD
United States, District of Columbia
MedStar Washington Hospital Center	Recruiting
Washington, District of Columbia, United States, 20010
Contact: Kassaye Sesaba 202-877-7452 Kassaye.T.Sesaba@medstar.net
Contact: Suman Singh 202-877-8475 Suman.singh@medstart.net
Principal Investigator: Steven Abramowitz, MD
Sub-Investigator: Kyle Reynolds, MD
Sub-Investigator: Misaki Kiguchi, MD
Sub-Investigator: Danielle Salazar, MD
Sub-Investigator: Saher Sabri, MD
United States, Illinois
Northwestern University	Recruiting
Chicago, Illinois, United States, 60611
Contact: Kristie Kennedy kristie.kennedy@northwestern.edu
Principal Investigator: Ramona Gupta, MD
Sub-Investigator: Kush Desai, MD
United States, Massachusetts
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Kathryn Nuzzolo KNUZZOLO@MGH.HARVARD.EDU
Principal Investigator: Julianne Stoughton, MD
Sub-Investigator: Luis Suarez, MD
Sub-Investigator: Abhisekh Mohapatra, MD
Sub-Investigator: Nikolaos Zacharias, MD
Sub-Investigator: Jahan Mohabeli, MD
United States, Michigan
University of Michigan Hospital	Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Breanne Miller 734-615-1431 bremill@med.umich.edu
Principal Investigator: William Sherk, MD
Sub-Investigator: David Williams, MD
Sub-Investigator: Minhajuddin Khaja, MD
Sub-Investigator: Amber Liles, MD
Sub-Investigator: Daniel Kirkpatrick, MD
United States, New Jersey
Englewood Hospital & Med Center	Recruiting
Englewood, New Jersey, United States, 07631
Contact: Delcia Fuentes 201-608-2234 Delcia.Fuentes@ehmchealth.org
Principal Investigator: Steven Elias, MD
United States, New York
Mount Sinai Medical Center	Recruiting
New York, New York, United States, 10029
Contact: Sophia Sinnins 212-241-8250 Sophia.Sinins@mountsinai.org
Contact: Abena Gyasi 212-241-8250 Abena.Gyasi@mountsinai.org
Principal Investigator: Windsor Ting, MD
United States, North Carolina
Atrium Health-Sanger Heart and Vascular Institute	Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Dana Amaro 704-355-4692 dana.amaro@atriumhealth.org
Principal Investigator: Erin Murphy, MD
United States, Ohio
Bethesda North	Recruiting
Cincinnati, Ohio, United States, 45242
Contact: Manuel Alcazar Manuel_Alcazar@trihealth.com
Principal Investigator: Patrick Muck, MD
Sub-Investigator: Mark Broering, MD
University Hospitals Cleveland	Recruiting
Cleveland, Ohio, United States, 44106
Contact: Janice Wolfe 216-844-2636 janice.wolfe@uhhospitals.org
Principal Investigator: Karem Harth, MD
Sub-Investigator: Mohammed Al-Natour, MD
Sub-Investigator: Yulanka Castro-Dominguez, MD
Cleveland Clinic Foundation	Recruiting
Cleveland, Ohio, United States, 44195
Contact: Emily Sprankle spranke@ccf.org
Contact: Carmen Czich CZICHC@ccf.org
Principal Investigator: Jon Quatromoni, MD
Sub-Investigator: Sean Lyden, MD
Sub-Investigator: Francis Caputo, MD
Sub-Investigator: Ali Khalifeh, MD
Sub-Investigator: Levester Kirksey, MD
United States, Pennsylvania
University of Pittsburgh Medical Center	Recruiting
Pittsburgh, Pennsylvania, United States, 14213
Contact: Judith Brimmeier 412-623-8486 brimmeierja@upmc.edu
Contact: Robin Brown brownr40@upmc.edu
Principal Investigator: Rabih Chaer, MD
Sub-Investigator: Eric Hager, MD
Sub-Investigator: Nathan Liang, MD
Sub-Investigator: Ulka Sachdev, MD
Sub-Investigator: Natalie Sridharan, MD
United States, Virginia
Sentara General Hospital	Recruiting
Norfolk, Virginia, United States, 23507
Contact: Sarah Havert 757-388-2991 sshavert@sentara.com
Principal Investigator: David Dexter, MD
United States, Washington
Lake Washington Vascular	Recruiting
Bellevue, Washington, United States, 98004
Contact: Kim Glorieux 425-453-1772 kimg@lkwv.com
Principal Investigator: Kathleen Gibson, MD
Sub-Investigator: Elica Inagaki, MD

Sponsors and Collaborators

W.L.Gore & Associates

Investigators

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Principal Investigator:	Kush Desai, MD	Northwestern University
Principal Investigator:	Kathleen Gibson, MD	Lake Washington Vascular Surgeons

More Information

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Responsible Party:	W.L.Gore & Associates
ClinicalTrials.gov Identifier:	NCT05489588
Other Study ID Numbers:	VNS 21-07
First Posted:	August 5, 2022 Key Record Dates
Last Update Posted:	March 6, 2024
Last Verified:	March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	Yes
Device Product Not Approved or Cleared by U.S. FDA:	Yes

Keywords provided by W.L.Gore & Associates:


VIAFORT Vein Stent Venous Thrombosis	Venous Stenosis Gore Venous Occlusion

Additional relevant MeSH terms:

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Thrombosis Venous Thrombosis Varicose Ulcer Leg Ulcer Ulcer Pathologic Processes	Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Skin Ulcer Skin Diseases Varicose Veins

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