Arterial Closure DeviceFERARINCT02455661
Femoral Closure Versus Radial Compression Devices Related to Percutaneous Coronary Interventions Study
A study testing TR Band (TM), AngioSeal and StarClose in people with Arterial Closure Device and Percutaneous Coronary Intervention (PCI), run by Universitätsmedizin Mannheim at 1 site in Germany.
Trial summary
FERARI is a single centre observational study comparing patients undergoing PCI either using radial compression devices or femoral closure devices at the corresponding access site. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arterial Closure Device, Percutaneous Coronary Intervention (PCI), Access Site Bleeding
- What is being tested?
- TR Band (TM), AngioSeal and StarClose
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2014to Oct 2019
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent about the study
- Elective PCI with following indications:
- Stable coronary artery disease, proven myocardial ischemia; cardiac arrhythmia; syncope; Unstable AP defined as NSTEMI but without cardiac troponin elevation; NSTEMI; STEMI
- patient eligible for coronary angiography and both radial and femoral PCI
- requirement of using a vascular closure device (without contraindications)
Who cannot join
- inability to understand and sign the informed consent term
- pregnancy
- less 18 years of age
- single diagnostic coronary angiography
- active or high bleeding risk (thrombocytopenia <50,000/µl)
- femoral approach and PCI without using a vascular closure device
- other conditions hampering involvement in the study
Trial locations and contacts
1 site in 1 country.
Germany1 site
First Department of Medicine, University Medical Centre Mannheim
Mannheim, 68167
About this study
FERARI is a single centre observational study comparing patients undergoing PCI either using radial compression devices or femoral closure devices at the corresponding access site.
First primary outcomes consist of the occurrence of vascular complications at the arterial access site including major bleedings as defined by common classification systems
Second primary outcomes consist of the occurrence of adverse cardiac events including all-cause mortality, target lesion and vessel revascularization (TLR and TVR) during 30 days and 12 months of follow-up.
- Conditions
- Arterial Closure Device, Percutaneous Coronary Intervention (PCI), Access Site Bleeding, Adverse Cardiac Events
- Being tested
- TR Band (TM), AngioSeal, StarClose
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TR Band (TM)Device
AngioSealDevice
StarCloseDevice
| Study group | Role | What they receive |
|---|---|---|
| Radial PCI with TR Band (TM) | Experimental | Patients with a PCI using the radial approach and the above radial compression device. Receives: Device: TR Band (TM) |
| Femoral PCI with AngioSeal device | Active comparator | Patients with a PCI using the femoral approach and the above femoral vascular closure device. Receives: Device: AngioSeal |
| Femoral PCI with StarClose device | Active comparator | Not described Receives: Device: StarClose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular complications at the arterial access site
Occurrence of vascular complications at the arterial access site including major bleedings as defined by common classification systems
Measured: 30 days
Adverse cardiac events
Occurrence of adverse cardiac events including all-cause mortality, target lesion and vessel revascularization (TLR and TVR).
Measured: 30 days
Adverse cardiac events
Occurrence of adverse cardiac events including all-cause mortality, target lesion and vessel revascularization (TLR and TVR).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2015 (estimated)
- Study startFeb 2014
- Primary completionMay 2018
- Study completionOct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Arterial Closure DeviceStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Radial closure by TR-Band.
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsmedizin Mannheim
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Behnes, Universitätsmedizin Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02455661
- Sponsor's protocol ID
- 2014-560N-MA
- Acronym
- FERARI
- Status last verified
- Oct 2019
- First submitted
- 14 May 2015
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Sartorius B, Behnes M, Unsal M, Hoffmann U, Lang S, Mashayekhi K, Borggrefe M, Akin I. Arterial access-site complications after use of a vascular closure device related to puncture height. BMC Cardiovasc Disord. 2017 Feb 16;17(1):64. doi: 10.1186/s12872-017-0484-7.
PubMed 28209184Fastner C, Behnes M, Unsal M, El-Battrawy I, Ansari U, Mashayekhi K, Hoffmann U, Lang S, Kuschyk J, Borggrefe M, Akin I. Clinical outcomes of femoral closure compared to radial compression devices following percutaneous coronary intervention: the FERARI study. Heart Vessels. 2017 May;32(5):520-530. doi: 10.1007/s00380-016-0901-3. Epub 2016 Nov 1.
PubMed 27803954
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Femoral Closure Versus Radial Compression Devices Related to Percutaneous Coronary Interventions Study
- ClinicalTrials.gov ID
- NCT02455661
- Acronym / sponsor ID
- FERARI / 2014-560N-MA
- Conditions
- Arterial Closure Device, Percutaneous Coronary Intervention (PCI), Access Site Bleeding, Adverse Cardiac Events
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Universitätsmedizin MannheimUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 28 May 2015 (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.
FERARI is a single centre observational study comparing patients undergoing PCI either using radial compression devices or femoral closure devices at the corresponding access site.
First primary outcomes consist of the occurrence of vascular complications at the arterial access site including major bleedings as defined by common classification systems
Second primary outcomes consist of the occurrence of adverse cardiac events including all-cause mortality, target lesion and vessel revascularization (TLR and TVR) during 30 days and 12 months of follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Radial closure by TR-Band.
| Arm | Type | Receives |
|---|---|---|
| Radial PCI with TR Band (TM) | Experimental | Device: TR Band (TM)Patients with a PCI using the radial approach and the above radial compression device. |
| Femoral PCI with AngioSeal device | Active comparator | Device: AngioSealPatients with a PCI using the femoral approach and the above femoral vascular closure device. |
| Femoral PCI with StarClose device | Active comparator | Device: StarClose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Informed consent about the study
- Elective PCI with following indications:
- Stable coronary artery disease, proven myocardial ischemia; cardiac arrhythmia; syncope; Unstable AP defined as NSTEMI but without cardiac troponin elevation; NSTEMI; STEMI
- patient eligible for coronary angiography and both radial and femoral PCI
- requirement of using a vascular closure device (without contraindications)
Key exclusion criteria (7 listed)
- inability to understand and sign the informed consent term
- pregnancy
- less 18 years of age
- single diagnostic coronary angiography
- active or high bleeding risk (thrombocytopenia <50,000/µl)
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 |
|---|---|---|
| TR Band (TM) | Device | Radial PCI with TR Band (TM) |
| AngioSeal | Device | Femoral PCI with AngioSeal device |
| StarClose | Device | Femoral PCI with StarClose device |
Primary outcome
Vascular complications at the arterial access site
Time frame: 30 days
Occurrence of vascular complications at the arterial access site including major bleedings as defined by common classification systems
Adverse cardiac events
Time frame: 30 days
Occurrence of adverse cardiac events including all-cause mortality, target lesion and vessel revascularization (TLR and TVR).
Adverse cardiac events
Time frame: 12 months
Occurrence of adverse cardiac events including all-cause mortality, target lesion and vessel revascularization (TLR and TVR).
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 Nov 2019.
- Derived from this study: PubMed 28209184Sartorius B, Behnes M, Unsal M, Hoffmann U, Lang S, Mashayekhi K, Borggrefe M, Akin I. Arterial access-site complications after use of a vascular closure device related to puncture height. BMC Cardiovasc Disord. 2017 Feb 16;17(1):64. doi: 10.1186/s12872-017-0484-7.
- Derived from this study: PubMed 27803954Fastner C, Behnes M, Unsal M, El-Battrawy I, Ansari U, Mashayekhi K, Hoffmann U, Lang S, Kuschyk J, Borggrefe M, Akin I. Clinical outcomes of femoral closure compared to radial compression devices following percutaneous coronary intervention: the FERARI study. Heart Vessels. 2017 May;32(5):520-530. doi: 10.1007/s00380-016-0901-3. Epub 2016 Nov 1.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TR Band (TM), AngioSeal and StarClose in people with Arterial Closure Device and Percutaneous Coronary Intervention (PCI), run by Universitätsmedizin Mannheim at 1 site in Germany.
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 5 inclusion and 7 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 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
Vascular complications at the arterial access site (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02455661, which also lists 2 linked publications.
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 Nov 2019.