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New treatment option for Venous Thromboses
Official title The GORE® VIABAHN® FORTEGRA Venous Stent Iliofemoral Study
ClinicalTrials.gov ID: NCT05489588
What this study is testing
- What it's testing
- This study is a prospective, non-randomized, multicenter, single-arm, clinical study to evaluate the performance, safety and efficacy of the GORE® VIABAHN® FORTEGRA Venous Stent (formerly known as GORE® VIAFORT Vascular Stent) for treatment of symptomatic iliofemoral venous obstruction.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Preoperative
- 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.
You likely can't join if
- 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...
- Patient has a known uncorrectable bleeding diathesis or active coagulopathy meeting the following definitions (all must be tested for):
- uncorrected INR\>2 (not as a result of warfarin or DOAC therapy), OR
- platelet count \ 1,000,000 cells/mm3, OR
See the full eligibility criteria
Who can join
- Preoperative
- 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
What rules you out
- 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):
- uncorrected INR\>2 (not as a result of warfarin or DOAC therapy), OR
- platelet count \ 1,000,000 cells/mm3, OR
- white blood cell count \ 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Stanford, California, United States
- Thornton, Colorado, United States
- Darien, Connecticut, United States
- New Haven, Connecticut, United States
- Washington D.C., District of Columbia, United States
- Bradenton, Florida, United States
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- Wellesley, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Englewood, New Jersey, United States
- Teaneck, New Jersey, United States
- New York, New York, United States
- Stony Brook, New York, United States
- Troy, New York, United States
- Chapel Hill, North Carolina, United States
- Charlotte, North Carolina, United States
- Raleigh, North Carolina, United States
- Cincinnati, Ohio, United States
- Cleveland, Ohio, United States
+ 6 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Stanford, California, United States; Thornton, Colorado, United States; Darien, Connecticut, United States; New Haven, Connecticut, United States; Washington D.C., District of Columbia, United States; Bradenton, Florida, United States and 20 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.