Clinical trial NCT03044002: BIOTRONIK 4French for AMBulatory Peripheral Intervention
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Artery Disease
Access Site Complication
Outpatient Treatment
Lead sponsor: Biotronik AG
Sponsor class: INDUSTRY
First posted: 2017-02-06
Enrollment: 821
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with infrainguinal Peripheral Artery Disease (PAD), requiring endovascular treatment

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.

Eligibility criteria: 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

Primary outcomes:
measure: Peri- and post-procedural access site complications (including homeostasis strategy failure; post-procedural defined as within 30 days post-intervention)
timeFrame: up to 30 days post procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medizinische Universitaet Graz
city: Dendermonde
country: Belgium
facility: A.Z.Sint-Blasius
city: Dijon
country: France
facility: CHU du Bocage
city: Trélazé
country: France
facility: Clinique Saint Joseph
city: Lugano
country: Switzerland
facility: Osepedale Regionale di Lugano
Study officials:
affiliation: Ospedale Regionale di Lugano - Sezione Civico
name: PD Dott. med. Jos van den Berg
role: PRINCIPAL_INVESTIGATOR
affiliation: Substitute Head of the Clinical Division of Angiology, Department of Internal Medicine
name: a.o. Univ. Prof. Dr. Marianne Brodmann
role: PRINCIPAL_INVESTIGATOR
References: