BIOTRONIK 4French for AMBulatory Peripheral Intervention

NCT03044002 | Completed

• 1 other identifier: C1602
• Study Type: observational
• Target: 821
• Locations: 4 countries
• Sites: 5

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

Conditions

Peripheral Artery Disease; Access Site Complication; Outpatient Treatment

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

4French Intervention

Patient with infrainguinal Peripheral Artery Disease (PAD), requiring endovascular treatment

Device: Biotronik 4 French Portfolio

6French Intervention

Patient with infrainguinal Peripheral Artery Disease (PAD), requiring endovascular treatment

Device: 6 French Portfolio

Interventions

Biotronik 4 French Portfolio DEVICE

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

4French Intervention

6 French Portfolio DEVICE

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

6French Intervention

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with infrainguinal Peripheral Artery Disease (PAD), requiring endovascular treatment

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biotronik AG: lead

Study Sites (5)

Medizinische Universitaet Graz

Graz, Austria

Location

A.Z.Sint-Blasius

Dendermonde, Belgium

Location

CHU du Bocage

Dijon, France

Location

Clinique Saint Joseph

Trélazé, France

Location

Osepedale Regionale di Lugano

Lugano, Switzerland

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2017
• First Posted: February 6, 2017
• Study Start: March 17, 2017
• Primary Completion: October 20, 2020
• Study Completion: October 20, 2020
• Last Updated: April 1, 2021

Record last verified: 2021-03

Locations

CH (1); FR (2); AU (1); BE (1)