Access Site Complication, Outpatient Treatment, Peripheral Artery Disease
Conditions
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.
Interventions
DEVICEBiotronik 4 French Portfolio
Ambulatory intervention by femoral access for endovascular treatment of lower-extremity peripheral artery disease
DEVICE6 French Portfolio
Ambulatory intervention by femoral access for endovascular treatment of lower-extremity peripheral artery disease
Sponsors
Biotronik AG
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Austria, Belgium, France, Switzerland
Outcome results
None listed