BIOTRONIK 4French for AMBulatory Peripheral Intervention (BIO4AMB)

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

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

Study Overview

• Status: Completed
• Conditions: Peripheral Artery Disease; Access Site Complication; Outpatient Treatment
• Intervention / Treatment: Device: Biotronik 4 French Portfolio; Device: 6 French Portfolio

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 Type: Observational
• Enrollment (Actual): 821

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria
    • Medizinische Universitaet Graz
• Belgium
  • Dendermonde, Belgium
    • A.Z.Sint-Blasius
• France
  • Dijon, France
    • Chu Du Bocage
  • Trélazé, France
    • Clinique Saint Joseph
• Switzerland
  • Lugano, Switzerland
    • Osepedale Regionale di Lugano

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient with infrainguinal Peripheral Artery Disease (PAD), requiring endovascular treatment

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
4French Intervention; Patient with infrainguinal Peripheral Artery Disease (PAD), requiring endovascular treatment	Device: Biotronik 4 French Portfolio; Ambulatory intervention by femoral access for endovascular treatment of lower-extremity peripheral artery disease
6French Intervention; Patient with infrainguinal Peripheral Artery Disease (PAD), requiring endovascular treatment	Device: 6 French Portfolio; Ambulatory intervention by femoral access for endovascular treatment of lower-extremity peripheral artery disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Biotronik AG
• Investigators: Principal Investigator: PD Dott. med. Jos van den Berg, Ospedale Regionale di Lugano - Sezione Civico; Principal Investigator: a.o. Univ. Prof. Dr. Marianne Brodmann, Substitute Head of the Clinical Division of Angiology, Department of Internal Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2017
• Primary Completion (Actual): October 20, 2020
• Study Completion (Actual): October 20, 2020

Study Registration Dates

• First Submitted: February 1, 2017
• First Submitted That Met QC Criteria: February 3, 2017
• First Posted (Estimate): February 6, 2017

Study Record Updates

• Last Update Posted (Actual): April 1, 2021
• Last Update Submitted That Met QC Criteria: March 31, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: C1602

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No