Is NCT05489588 recruiting in Stanford, CA?

Yes, NCT05489588 is currently recruiting participants at its Stanford, CA location. This venous thromboses clinical trial is actively enrolling qualified participants.

How do I join the venous thromboses clinical trial in Stanford?

To join this clinical trial in Stanford, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Stanford clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Venous Thromboses Clinical Trial in Stanford, CA

About This Venous Thromboses Study in Stanford

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.

Sponsor: W.L.Gore & Associates

Who Can Participate

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):

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).

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Stanford?

Yes, this clinical trial (NCT05489588) has an active research site in Stanford, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Venous Thromboses Treatment Options in Stanford, CA

If you're searching for venous thromboses treatment options in Stanford, CA, this clinical trial (NCT05489588) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Stanford research site is actively enrolling participants for this clinical trial. You'll receive care from experienced venous thromboses specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Venous Thromboses Clinical Trial in Stanford, CA

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