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BIOTRONIK 4French for AMBulatory Peripheral Intervention (BIO4AMB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03044002
Recruitment Status : Active, not recruiting
First Posted : February 6, 2017
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Biotronik AG

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

Condition or disease Intervention/treatment
Peripheral Artery Disease Access Site Complication Outpatient Treatment Device: Biotronik 4 French Portfolio Device: 6 French Portfolio

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.

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Study Type : Observational
Actual Enrollment : 821 participants
Observational Model: Case-Control
Time Perspective: Prospective
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
Actual Study Start Date : March 17, 2017
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
4French Intervention
Patient with infrainguinal Peripheral Artery Disease (PAD), requiring endovascular treatment
Device: Biotronik 4 French Portfolio
Ambulatory intervention by femoral access for endovascular treatment of lower-extremity peripheral artery disease

6French Intervention
Patient with infrainguinal Peripheral Artery Disease (PAD), requiring endovascular treatment
Device: 6 French Portfolio
Ambulatory intervention by femoral access for endovascular treatment of lower-extremity peripheral artery disease




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with infrainguinal Peripheral Artery Disease (PAD), requiring endovascular treatment
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03044002


Locations
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Austria
Medizinische Universitaet Graz
Graz, Austria
Belgium
A.Z.Sint-Blasius
Dendermonde, Belgium
France
CHU du Bocage
Dijon, France
Clinique Saint Joseph
Trélazé, France
Switzerland
Osepedale Regionale di Lugano
Lugano, Switzerland
Sponsors and Collaborators
Biotronik AG
Investigators
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Principal Investigator: PD Dott. med. Jos van den Berg Ospedale Regionale di Lugano - Sezione Civico
Principal Investigator: a.o. Univ. Prof. Dr. Marianne Brodmann Substitute Head of the Clinical Division of Angiology, Department of Internal Medicine
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Responsible Party: Biotronik AG
ClinicalTrials.gov Identifier: NCT03044002    
Other Study ID Numbers: C1602
First Posted: February 6, 2017    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases