BIOTRONIK 4French for AMBulatory Peripheral Intervention

Peripheral Artery Disease Clinical Trial

— BIO4AMB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03044002
• Other study ID #: C1602
• Status: Completed
• Start date: March 17, 2017
• Est. completion date: October 20, 2020

Study information

• Verified date: March 2021
• Source: Biotronik AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 821
• Est. completion date: October 20, 2020
• Est. primary completion date: October 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Access Site Complication
• Outpatient Treatment
• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Device:
• Biotronik 4 French Portfolio
Ambulatory intervention by femoral access for endovascular treatment of lower-extremity peripheral artery disease
• 6 French Portfolio
Ambulatory intervention by femoral access for endovascular treatment of lower-extremity peripheral artery disease

Locations

Country	Name	City	State
Austria	Medizinische Universitaet Graz	Graz
Belgium	A.Z.Sint-Blasius	Dendermonde
France	CHU du Bocage	Dijon
France	Clinique Saint Joseph	Trélazé
Switzerland	Osepedale Regionale di Lugano	Lugano

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik AG

Countries where clinical trial is conducted

Austria,  Belgium,  France,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	up to 30 days post procedure