Clinical trial NCT05489588: The GORE® VIAFORT Vascular Stent Iliofemoral Study
Official title: Evaluation of the GORE® VIAFORT Vascular Stent for Treatment of Symptomatic Iliofemoral Venous Obstruction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Venous Thromboses
Venous Disease
Venous Leg Ulcer
Venous Stasis
Venous Ulcer
Venous Stenosis
Venous Occlusion
Vein Thrombosis
Vein Occlusion
Vein Disease
Keywords: VIAFORT
Vein Stent
Venous Thrombosis
Venous Stenosis
Gore
Venous Occlusion
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2022-08-05
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study is a prospective, multicenter, non-randomized, single-arm study.
Primary purpose: TREATMENT

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.

Detailed description: A maximum of 30 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.

Eligibility 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 (all must be tested for):

  1. uncorrected INR\>2 (not as a result of warfarin or DOAC therapy), OR
  2. platelet count \<50,000 or \>1,000,000 cells/mm3, OR
  3. 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).
* Patient has known homozygous or acquired coagulation defect (e.g., Protein C or Protein S deficiency) that cannot be treated with therapeutic anticoagulation.
* Patient has a planned surgical intervention that has the potential to clinically interfere with the endpoints of this treatment (other than pre-stenting procedures such as thrombolysis or thrombectomy) within 30 days prior to or within 30 days after the planned study procedure. Examples include surgical interventions that may impact mobility, and surgical interventions that require cessation of therapeutic antiplatelet or anticoagulation within 30 days following the index 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.
* 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 can be managed, and with an active clinical plan in place 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 \>45. Patients with a BMI of up to 45 may be enrolled provided that diagnostic quality ultrasound of the implant sites can be performed.
* Patient is actively undergoing or plans to begin cancer treatment.
* Patients with hypercoagulable states that are unwilling to take anticoagulant medications on a long-term basis.
* Patient has contraindication to thrombolytics, anticoagulants, or iodinated contrast necessary for the index procedure and long-term medical therapy (contrast pre-medication is acceptable).

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.

Primary outcomes:
measure: Composite of safety events
timeFrame: 12 months (Stent Embolization) or 30 days (all other components)
measure: Primary efficacy as assessed by primary patency
timeFrame: 12 months
Secondary outcomes:
measure: Number of subjects with primary patency as confirmed by imaging and adverse events
timeFrame: 60 months
measure: Number of subjects with secondary patency as confirmed by imaging and adverse events
timeFrame: 60 months
measure: Number of subjects with clinically driven target lesion revascularization as confirmed by imaging and adverse events
timeFrame: 60 months
measure: Number of subjects with device fracture as confirmed with imaging
timeFrame: 60 months
measure: Number of subjects with stent embolization as confirmed with imaging
timeFrame: 12 months
measure: Number of subjects with device- or procedure-related death
timeFrame: 30 days
measure: Number of subjects with clinically significant pulmonary embolism as confirmed with imaging and adverse events
timeFrame: 30 days
measure: Number of subjects with device- or procedure-related vascular injury as confirmed with adverse events
timeFrame: 30 days
measure: Number of subjects with device- or procedure-related major bleeding events as confirmed with adverse events
timeFrame: 30 days
measure: Revised Venous Clinical Severity Scale (rVCSS)
timeFrame: 60 months
measure: Revised Venous Clinical Severity Scale (rVCSS) Pain
timeFrame: 60 months
measure: Venous Insufficiency Epidemiological and Economic Study - Quality of Life/Symptoms (VEINES-QOL/Sym) VEINES-QOL/Sym
timeFrame: 60 months
measure: Villalta
timeFrame: 60 months
measure: 5 Level EuroQol-5 Dimension (EQ-5D-5L)
timeFrame: 60 months
measure: Technical success
timeFrame: Index procedure (post-op day 0)
measure: Lesion success
timeFrame: Index procedure (post-op day 0)
measure: Procedural success
timeFrame: Index procedure through hospital discharge (discharge estimated as up to 30 days post-treatment)
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Thornton
country: United States
facility: Advanced Heart and Vein (ClinRe)
state: Colorado
city: Darien
country: United States
facility: Vascular Care Group
state: Connecticut
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Hospital
state: Michigan
city: Englewood
country: United States
facility: Englewood Hospital & Med Center
state: New Jersey
city: Teaneck
country: United States
facility: Holy Name Medical Center
state: New Jersey
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Stony Brook
country: United States
facility: Stony Brook
state: New York
city: Troy
country: United States
facility: St. Peter's Vascular Associates
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina - Chapel Hill
state: North Carolina
city: Charlotte
country: United States
facility: Atrium Health-Sanger Heart and Vascular Institute
state: North Carolina
city: Raleigh
country: United States
facility: NC Heart and Vascular Research
state: North Carolina
city: Cincinnati
country: United States
facility: Bethesda North
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
city: Dallas
country: United States
facility: UT Southwestern
state: Texas
city: Norfolk
country: United States
facility: Sentara General Hospital
state: Virginia
city: Bellevue
country: United States
facility: Lake Washington Vascular
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin - Froedtert Hospital
state: Wisconsin
Study officials:
affiliation: Northwestern University
name: Kush Desai, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lake Washington Vascular Surgeons
name: Kathleen Gibson, MD
role: PRINCIPAL_INVESTIGATOR
References: