Peripheral Artery DiseaseBIO4AMBNCT03044002
BIOTRONIK 4French for AMBulatory Peripheral Intervention
An observational study of Peripheral Artery Disease and Access Site Complication, run by Biotronik AG at 5 sites in 4 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Peripheral Artery Disease, Access Site Complication, Outpatient Treatment
- What is being tested?
- Biotronik 4 French Portfolio and 6 French Portfolio
- Type of treatment
- Medical device
- How many people
- 821 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 17 Mar 2017to 20 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with infrainguinal Peripheral Artery Disease (PAD), requiring endovascular treatment
Who may be able to join
- 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
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
About this study
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
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
Read the 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.
- Being tested
- Biotronik 4 French Portfolio, 6 French Portfolio
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biotronik 4 French PortfolioDevice
Ambulatory intervention by femoral access for endovascular treatment of lower-extremity peripheral artery disease
6 French PortfolioDevice
Ambulatory intervention by femoral access for endovascular treatment of lower-extremity peripheral artery disease
| Study group | Role | What they receive |
|---|---|---|
| 4French Intervention | Patient with infrainguinal Peripheral Artery Disease (PAD), requiring endovascular treatment Receives: Device: Biotronik 4 French Portfolio | |
| 6French Intervention | Patient with infrainguinal Peripheral Artery Disease (PAD), requiring endovascular treatment Receives: Device: 6 French Portfolio |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 30 days post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2017 (estimated)
- Study start17 Mar 2017
- Primary completion20 Oct 2020
- Study completion20 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 821 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- PD Dott. med. Jos van den Berg, Principal investigator, Ospedale Regionale di Lugano - Sezione Civicoa.o. Univ. Prof. Dr. Marianne Brodmann, Principal investigator, Substitute Head of the Clinical Division of Angiology, Department of Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03044002
- Sponsor's protocol ID
- C1602
- Acronym
- BIO4AMB
- Status last verified
- Mar 2021
- First submitted
- 1 Feb 2017
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03044002
- Acronym / sponsor ID
- BIO4AMB / C1602
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 821 participants (actual)
- Lead sponsor
- Biotronik AGIndustry (pharma, biotech, devices)
- Study start
- 17 Mar 2017 (actual)
- Primary completion
- 20 Oct 2020 (actual)
- Study completion
- 20 Oct 2020 (actual)
- First posted
- 6 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4French Intervention | – | Device: Biotronik 4 French PortfolioPatient with infrainguinal Peripheral Artery Disease (PAD), requiring endovascular treatment |
| 6French Intervention | – | Device: 6 French PortfolioPatient with infrainguinal Peripheral Artery Disease (PAD), requiring endovascular treatment |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with infrainguinal Peripheral Artery Disease (PAD), requiring endovascular treatment
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biotronik 4 French PortfolioAmbulatory intervention by femoral access for endovascular treatment of lower-extremity peripheral artery disease | Device | 4French Intervention |
| 6 French PortfolioAmbulatory intervention by femoral access for endovascular treatment of lower-extremity peripheral artery disease | Device | 6French Intervention |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
Related trials for Peripheral Artery Disease
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
Active, not recruiting
Preventing Kidney Injury Using Carbon Dioxide as Contrast Medium in Patients With Peripheral Arterial Disease (PAD) and Chronic Kidney Disease (CKD) Having Arterial Intervention
Peripheral Arterial Disease, Chronic Kidney Diseases
Recruiting
Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease
Peripheral Artery Disease, Diabetes Mellitus
RecruitingPhase 4
Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
Peripheral Arterial Disease
RecruitingObservational study
Aspiration Thrombectomy Using the Symphony or Prodigy System
Arterial Thromboembolism, Venous Thromboembolism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
PD Dott. med. Jos van den Berg principal investigator
Ospedale Regionale di Lugano - Sezione Civico
a.o. Univ. Prof. Dr. Marianne Brodmann principal investigator
Substitute Head of the Clinical Division of Angiology, Department of Internal Medicine
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Artery Disease and Access Site Complication, run by Biotronik AG at 5 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France, Austria, Belgium, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.