BIOTRONIK 4French for AMBulatory Peripheral Intervention (BIO4AMB)

Biotronik

Status

Completed

Conditions

Outpatient Treatment

Peripheral Artery Disease

Access Site Complication

Treatments

Device: Biotronik 4 French Portfolio

Device: 6 French Portfolio

Study type

Observational

Funder types

Industry

Identifiers

NCT03044002

C1602

Details and patient eligibility

About

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

Full description

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

Enrollment

821 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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