Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:39 PM
Ignite Modification Date:
2025-12-24 @ 1:39 PM
NCT ID:
NCT01406795
Eligibility Criteria:
Inclusion Criteria:
* Patient is at least 18 years old
* Patient has clinical manifestations (i.e. symptoms and/or signs) of chronic DVT of an extremity. The Venous Clinical Severity Score (VCSS) will be used to determine if the patient is currently suffering from chronic DVT, with a VCSS score of 4 or greater necessary for inclusion.
* Imaging confirmation of venous occlusion or stenosis (\>50%) involving the femoral, and/or popliteal veins
* Obstructed vessel caliber can accommodate a 7FR System, from insertion site to target segment
* Patient is able to read and answer a questionnaire in English
Exclusion Criteria:
* History of life-threatening reaction to contrast material
* Unwilling or unable to provide informed consent, or return for required follow-up evaluations
* Participating in another investigational study that has not completed follow-up testing
* Cannot receive outpatient anticoagulation such as LMWH and/or vitamin K antagonists (VKAs)
* Absolute contraindication to contrast media or renal insufficiency (baseline creatinine \>2.0 mg/dL).
* Either a history or presence of heparin-induced thrombocytopenia antibodies
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01406795
Study Brief:
Protocol Section:
NCT01406795