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 @ 11:55 PM
Ignite Modification Date:
2025-12-24 @ 11:55 PM
NCT ID:
NCT01353651
Eligibility Criteria:
Inclusion Criteria:
* Age between 40 and 90 years-old
* De novo atheromatous common femoral artery stenosis
* Symptomatic lesions (Rutherford stages 3, 4, 5 and 6)
* Haemodynamically significant lesion
* Written informed consent
Exclusion Criteria:
* Restenosis
* Non-atheromatous lesions (dysplasia, post-traumatic, inflammatory)
* external iliac thrombosis and / or common femoral side to treat
* Contraindication to open surgery or endovascular treatment
* Contraindication to anesthesia
* Indication of aorto-femoral, ilio-femoral, femoral-popliteal or femoro-tibialis bypass to associate with the common femoral revascularization
* Indication of a surgical approach to the external iliac artery through a retroperitoneal
* Asymptomatic lesions
* Life expectancy less than one year
* Refusing patient
* Inability to monitor during the test period
* Participation in another clinical trial
* Pregnant Women
* No written informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
90 Years
Study:
NCT01353651
Study Brief:
Protocol Section:
NCT01353651