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 @ 11:54 PM
Ignite Modification Date:
2025-12-24 @ 11:54 PM
NCT ID:
NCT01663051
Eligibility Criteria:
Inclusion Criteria:
* Symptomatic venous outflow obstruction in up to two iliofemoral venous segments (one in each limb), demonstrated by:
* CEAP 'C' ≥ 3, or
* VCSS pain score ≥ 2
Exclusion Criteria:
* \< 18 years of age
* Pregnant or planning to become pregnant in the next 12 months
* Planned surgical or interventional procedures (except thrombolysis and thrombectomy in preparation for the procedure or vena cava filter placement prior to stent implantation in patients at high risk for pulmonary embolism) within 30 days prior to or after the study procedure.
* Lesions with intended treatment lengths extending into the inferior vena cava or below the level of the lesser trochanter
* Previous stenting of the target vessel
* Iliofemoral venous segment unsuitable for treatment with available sizes of study devices
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01663051
Study Brief:
Protocol Section:
NCT01663051