NCT03044002

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 821 (actual)
• Sponsor: Biotronik AG · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Peripheral Artery Disease
• Access Site Complication
• Outpatient Treatment

Interventions

Type	Name	Description
DEVICE	Biotronik 4 French Portfolio	Ambulatory intervention by femoral access for endovascular treatment of lower-extremity peripheral artery disease
DEVICE	6 French Portfolio	Ambulatory intervention by femoral access for endovascular treatment of lower-extremity peripheral artery disease

Timeline

• Start date: 2017-03-17
• Primary completion: 2020-10-20
• Completion: 2020-10-20
• First posted: 2017-02-06
• Last updated: 2021-04-01

Locations

5 sites across 4 countries: Austria, Belgium, France, Switzerland