- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02455661
Femoral Closure Versus Radial Compression Devices Related to Percutaneous Coronary Interventions Study (FERARI)
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Mannheim, Germany, 68167
- First Department of Medicine, University Medical Centre Mannheim
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Radial PCI with TR Band (TM)
Patients with a PCI using the radial approach and the above radial compression device.
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Active Comparator: Femoral PCI with AngioSeal device
Patients with a PCI using the femoral approach and the above femoral vascular closure device.
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Active Comparator: Femoral PCI with StarClose device
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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30 days
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Adverse cardiac events
Time Frame: 30 days
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Occurrence of adverse cardiac events including all-cause mortality, target lesion and vessel revascularization (TLR and TVR).
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30 days
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Adverse cardiac events
Time Frame: 12 months
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Occurrence of adverse cardiac events including all-cause mortality, target lesion and vessel revascularization (TLR and TVR).
|
12 months
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Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- Fastner 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2014-560N-MA
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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