BIOTRONIK 4French for AMBulatory Peripheral Intervention

Biotronik AG821 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

821

Conditions

Peripheral Artery Disease Access Site Complication Outpatient Treatment

Interventions

Biotronik 4 French PortfolioDEVICE

Ambulatory intervention by femoral access for endovascular treatment of lower-extremity peripheral artery disease

6 French PortfolioDEVICE

Ambulatory intervention by femoral access for endovascular treatment of lower-extremity peripheral artery disease

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (5)

Medizinische Universitaet Graz

Graz, Austria

A.Z.Sint-Blasius

Dendermonde, Belgium

CHU du Bocage

Dijon, France

Clinique Saint Joseph

Trélazé, France

Osepedale Regionale di Lugano

Lugano, Switzerland

Outcomes

Primary Outcomes

Peri- and post-procedural access site complications (including homeostasis strategy failure; post-procedural defined as within 30 days post-intervention)

Access site complications are defined as a composite of: * Groin hematoma (larger than 5 cm in diameter, visible by sonography, and hemoglobin decrease \<3 g/dL) * Pseudoaneurysm * Groin as well as retroperitoneal bleeding (defined as requiring acute intervention for haemostasis, need for blood transfusions, or haemoglobin decrease \>3 g/dL) * AV fistula (visible by shunting in colour coded sonography between the common femoral artery and vein) * Arterial dissections at access site (visible with fluoroscopy or sonography as a membrane causing stenosis in the vessel lumen) * Thrombosis * VCD related ASCs

Time frame: up to 30 days post procedure

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.