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:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-25 @ 3:37 AM
NCT ID:
NCT03044002
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years or minimum age as required by local regulations
* Ability to walk
* Subject must be willing to sign patient Informed Consent (PIC)
* Patient with infrainguinal arteries lesion(s) suitable to be treated during an ambulatory endovascular intervention
Exclusion Criteria:
* No possibility of an ambulatory management
* Physical fitness classified as ASA ≥ 4 (American Society of Anaesthesiologists)
* Coagulation disorders
* Acute ischemia
* Less than 1month live expectancy
* Pregnant or breast feeding females or females who intend to become pregnant during the time of the study (pregnancy test required for all women with child bearing potential)
* Subject currently enrolled in other medical or drug study and has not reached the primary outcome measures
* Patient contraindicated for antiplatelet therapy, anticoagulants and antithrombotics
* Other access than common femoral
* Home alone the first night
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT03044002
Study Brief:
Protocol Section:
NCT03044002