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Completed

NCT Number: NCT03044002

BIOTRONIK 4French for AMBulatory Peripheral Intervention

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

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Key information

Conditions

Peripheral Artery Disease Access Site Complication Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Outpatient Treatment Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medizinische Universitaet Graz, Graz, Austria

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biotronik 4 French Portfolio

Device

Ambulatory intervention by femoral access for endovascular treatment of lower-extremity peripheral artery disease

6 French Portfolio

Device

Ambulatory intervention by femoral access for endovascular treatment of lower-extremity peripheral artery disease

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Biotronik AG

Industry

Registry information

Official study 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

Acronym: BIO4AMB

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Feb 6, 2017
Registry last updated
Apr 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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