The GORE® VIAFORT Vascular Stent Iliofemoral Study

Venous Leg Ulcer Clinical Trial

Official title:

Evaluation of the GORE® VIAFORT Vascular Stent for Treatment of Symptomatic Iliofemoral Venous Obstruction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05489588
• Other study ID #: VNS 21-07
• Status: Recruiting
• Phase: N/A
• Start date: March 2, 2023
• Est. completion date: April 2029

Study information

• Verified date: March 2024
• Source: W.L.Gore & Associates
• Contact: Carl Conway
• Phone: 6175952277
• Email: cconway[@]wlgore.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 165
• Est. completion date: April 2029
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Leg Ulcer
• Thrombosis
• Ulcer
• Varicose Ulcer
• Vein Disease
• Vein Occlusion
• Vein Thrombosis
• Venous Disease
• Venous Leg Ulcer
• Venous Occlusion
• Venous Stasis
• Venous Stenosis
• Venous Thromboses
• Venous Thrombosis
• Venous Ulcer

Intervention

Device:
• GORE® VIAFORT Vascular Stent
Treatment of unilateral symptomatic iliofemoral venous obstruction with the GORE® VIAFORT Vascular Stent.

Locations

Country	Name	City	State
United States	University of Michigan Hospital	Ann Arbor	Michigan
United States	Lake Washington Vascular	Bellevue	Washington
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of North Carolina - Chapel Hill	Chapel Hill	North Carolina
United States	Atrium Health-Sanger Heart and Vascular Institute	Charlotte	North Carolina
United States	Northwestern University	Chicago	Illinois
United States	Bethesda North	Cincinnati	Ohio
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	University Hospitals Cleveland	Cleveland	Ohio
United States	UT Southwestern	Dallas	Texas
United States	Vascular Care Group	Darien	Connecticut
United States	Englewood Hospital & Med Center	Englewood	New Jersey
United States	Medical College of Wisconsin - Froedtert Hospital	Milwaukee	Wisconsin
United States	Mount Sinai Medical Center	New York	New York
United States	Sentara General Hospital	Norfolk	Virginia
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Stanford University School of Medicine	Stanford	California
United States	Stony Brook	Stony Brook	New York
United States	Holy Name Medical Center	Teaneck	New Jersey
United States	MedStar Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
W.L.Gore & Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 months (Stent Embolization) or 30 days (all other components)
Primary	Primary efficacy as assessed by primary patency	Rate of subjects with primary patency as confirmed by imaging and adverse events	12 months
Secondary	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	60 months
Secondary	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.	60 months
Secondary	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.	60 months
Secondary	Number of subjects with device fracture as confirmed with imaging	Number of subjects with device fracture as confirmed with imaging.	60 months
Secondary	Number of subjects with stent embolization as confirmed with imaging	Number of subjects with stent embolization as confirmed with imaging	12 months
Secondary	Number of subjects with device- or procedure-related death	Number of subjects with device- or procedure-related death	30 days
Secondary	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.	30 days
Secondary	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.	30 days
Secondary	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.	30 days
Secondary	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.	60 months
Secondary	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.	60 months
Secondary	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.	60 months
Secondary	Villalta	Change in Villalta Measurement through 60-month follow-up compared to baseline prior to treatment.	60 months
Secondary	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.	60 months
Secondary	Technical success	Number of subjects with successful delivery and deployment of the stent to the intended location, and removal of delivery system.	Index procedure (post-op day 0)
Secondary	Lesion success	Number of subjects with evidence of =50% residual stenosis at the conclusion of the index procedure as measured by IVUS or venogram.	Index procedure (post-op day 0)
Secondary	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.	Index procedure through hospital discharge (discharge estimated as up to 30 days post-treatment)