BIOTRONIK 4French for AMBulatory Peripheral Intervention

BIOTRONIK 4French for AMBulatory Peripheral Intervention. A Multicenter, Controlled Trial Comparing 4French Versus 6French Femoral Access for Endovascular Treatment of Lower-extremity Peripheral Artery Disease in an Ambulatory Setting: BIO4AMB

BIOTRONIK 4French for AMBulatory peripheral intervention. A multicenter, controlled trial comparing 4French versus 6French femoral access for endovascular treatment of lower-extremity peripheral artery disease in an ambulatory setting: BIO4AMB

Controlled, multicenter, non-inferiority trial to compare the rate of access site complications (ASC) in 4French (4F) vs. 6French (6F) femoral access endovascular interventions.

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