RECRUITING

The GORE® VIAFORT Vascular Stent Iliofemoral Study

Conditions

Venous Thromboses Venous Disease Venous Leg Ulcer Venous Stasis Venous Ulcer Venous Stenosis Venous Occlusion Vein Thrombosis Vein Occlusion Vein Disease VIAFORT Vein Stent Venous Thrombosis Gore

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-03-02

Study Completion:2031-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05489588

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Carl Conway

CONTACT

6175952277

cconway@wlgore.com

Leonard Resecker

CONTACT

62356520649287074940

lresecke@wlgore.com

Principal Investigator

Kush Desai, MD

PRINCIPAL_INVESTIGATOR

Northwestern University

Kathleen Gibson, MD

PRINCIPAL_INVESTIGATOR

Lake Washington Vascular Surgeons

Study Locations (Sites)

Stanford University School of Medicine

Stanford, California, 94305

United States

Advanced Heart and Vein (ClinRe)

Thornton, Colorado, 80023

United States

Vascular Care Group

Darien, Connecticut, 06820

United States

MedStar Washington Hospital Center

Washington, District of Columbia, 20010

United States

Northwestern University

Chicago, Illinois, 60611

United States

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

University of Michigan Hospital

Ann Arbor, Michigan, 48109

United States

Englewood Hospital & Med Center

Englewood, New Jersey, 07631

United States

Holy Name Medical Center

Teaneck, New Jersey, 07666

United States

Mount Sinai Medical Center

New York, New York, 10029

United States

Stony Brook

Stony Brook, New York, 11790

United States

St. Peter's Vascular Associates

Troy, New York, 12180

United States

University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599

United States

Atrium Health-Sanger Heart and Vascular Institute

Charlotte, North Carolina, 28204

United States

NC Heart and Vascular Research

Raleigh, North Carolina, 27519

United States

Bethesda North

Cincinnati, Ohio, 45242

United States

University Hospitals Cleveland

Cleveland, Ohio, 44106

United States

Cleveland Clinic Foundation

Cleveland, Ohio, 44195

United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 14213

United States

The Miriam Hospital

Providence, Rhode Island, 02906

United States

UT Southwestern

Dallas, Texas, 75390

United States

Sentara General Hospital

Norfolk, Virginia, 23507

United States

Lake Washington Vascular

Bellevue, Washington, 98004

United States

Medical College of Wisconsin - Froedtert Hospital

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: W.L.Gore & Associates

Kush Desai, MD, PRINCIPAL_INVESTIGATOR, Northwestern University
Kathleen Gibson, MD, PRINCIPAL_INVESTIGATOR, Lake Washington Vascular Surgeons

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-02

Study Completion Date2031-03

Study Record Updates

Study Start Date2023-03-02

Study Completion Date2031-03

Terms related to this study

Keywords Provided by Researchers

VIAFORT
Vein Stent
Venous Thrombosis
Venous Stenosis
Gore
Venous Occlusion

Additional Relevant MeSH Terms

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