BIOTRONIK 4French for AMBulatory Peripheral Intervention

Completed

• Conditions: Peripheral Artery Disease; Access Site Complication; Outpatient Treatment

• Registration Number: NCT03044002
• Lead Sponsor: Biotronik AG

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2017-02-01
• Study First Submitted QC: 2017-02-03
• Study First Posted: 2017-02-06
• Study Start: 2017-03-17
• Primary Completion: 2020-10-20
• Study Completion: 2020-10-20
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-31
• Last Update Posted: 2021-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 821

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Peri- and post-procedural access site complications (including homeostasis strategy failure; post-procedural defined as within 30 days post-intervention)	up to 30 days post procedure	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

Trial Locations

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