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The GORE® VIAFORT Vascular Stent IVC Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05409976
Recruitment Status : Recruiting
First Posted : June 8, 2022
Last Update Posted : February 6, 2024
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates

Brief Summary:
This study is a prospective, multicenter, non-randomized, single-arm study to evaluate the performance, safety, and efficacy of the GORE® VIAFORT Vascular Stent for treatment of symptomatic inferior vena cava obstruction with or without combined iliofemoral obstruction in adult patients.

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 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® 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 111 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 Inferior Vena Cava Obstruction With or Without Combined Iliofemoral Obstruction
Actual Study Start Date : October 25, 2022
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : January 2029

Arm Intervention/treatment
Experimental: GORE® VIAFORT Vascular Stent
GORE® VIAFORT Vascular Stent
Device: GORE® VIAFORT Vascular Stent
Treatment of symptomatic IVC obstruction with or without combined iliofemoral obstruction with the GORE® VIAFORT Vascular Stent.




Primary Outcome Measures :
  1. Composite of efficacy and safety events [ Time Frame: 12 months ]

    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


Secondary Outcome Measures :
  1. 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

  2. Number of subjects with secondary patency as confirmed by imaging and adverse events [ Time Frame: 60 months ]
    Number of subjects with freedom from permanent loss of blood flow through the device, regardless of reintervention.

  3. 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.

  4. Number of subjects with device fracture as confirmed with imaging [ Time Frame: 60 months ]
    Number of subjects with device fracture as confirmed with imaging.

  5. Number of subjects with stent embolization as confirmed with imaging [ Time Frame: 12 months ]
    Number of subjects with stent embolization as confirmed with imaging.

  6. Number of subjects with device- or procedure-related death [ Time Frame: 30 days ]
    Number of subjects with device- or procedure-related death.

  7. 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.

  8. 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.

  9. 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.

  10. 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.


  11. 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.


  12. 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.

  13. Villalta [ Time Frame: 60 months ]
    Change in Villalta Measurement through 60-month follow-up compared to baseline prior to treatment.

  14. 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.

  15. 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.

  16. 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.

  17. 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.



Information from the National Library of Medicine

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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.

Preoperative Exclusion Criteria:

  • Patient is a pregnant or breastfeeding woman, a woman planning to become pregnant through the 12-month visit, or a woman who is unwilling to practice an acceptable method of preventing pregnancy 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 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 obstruction of the inferior vena cava defined as occlusion or at least 50% reduction in target vessel lumen as measured by procedural IVUS and venogram, with or without non-malignant obstruction of the common femoral vein, external iliac vein, and/or common iliac vein.
  • 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 the inferior vena cava and may include iliofemoral segments with intent to stent all affected iliofemoral and caval segments.
  • 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.
  • Patient does not have an inferior vena cava filter present within the target stent area at the time of investigational device placement. Patients with an inferior vena cava filter present within the target stent area must have the filter successfully removed prior to investigational device placement. Successful removal is defined as removal of the main body of the filter and intra-luminal fragments such that there is minimal risk to luminal integrity per investigator/sub-investigator discretion AND freedom from bleeding, vascular injury, or hemodynamically significant pulmonary embolism. After successful filter removal, investigational device placement can occur within the same procedure.

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): NCT05409976


Contacts
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Contact: Carl Conway 6175952277 cconway@wlgore.com
Contact: Leonard Resecker 9287074940 lresecke@wlgore.com

Locations
Show Show 19 study locations
Sponsors and Collaborators
W.L.Gore & Associates
Investigators
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Principal Investigator: Kush Desai, MD Northwestern University
Principal Investigator: Stephen Black, MD, FRCS (Ed), FEBVS Guy's and St Thomas' NHS Foundation Trust
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Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT05409976    
Other Study ID Numbers: VNS 21-05
First Posted: June 8, 2022    Key Record Dates
Last Update Posted: February 6, 2024
Last Verified: February 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