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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Biotronik AG
- Enrollment
- 821
- Locations
- 5
- Primary Endpoint
- Peri- and post-procedural access site complications (including homeostasis strategy failure; post-procedural defined as within 30 days post-intervention)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Peri- and post-procedural access site complications (including homeostasis strategy failure; post-procedural defined as within 30 days post-intervention)
Time Frame: 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
Secondary Outcomes
No secondary outcomes reported