BIOTRONIK 4French for AMBulatory Peripheral Intervention

Study Overview
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Brief Summary
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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
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Controlled, multicenter, non-inferiority trial to compare the rate of access site complications (ASC) in 4French (4F) vs. 6French (6F) femoral access endovascular interventions.

Official Title
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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

Conditions
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Peripheral Artery Disease, Access Site Complication, Outpatient Treatment

Intervention / Treatment
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* Device: Biotronik 4 French Portfolio
* Device: 6 French Portfolio


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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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 |