NCT02455661|Completed
Femoral Closure Versus Radial Compression Devices Related to Percutaneous Coronary Interventions Study
FERARI
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FERARI
Sponsor study identifier
interventional
600
1 country
1
Study Start
February 2014
Actual (reported)Primary Completion
May 2018
Actual (reported)Study Completion
October 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2014
Actual (reported)May 14, 2015
Actual (reported)May 28, 2015
Actual (reported)May 2018
Actual (reported)October 2019
Actual (reported)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
30 days
Adverse cardiac events
Occurrence of adverse cardiac events including all-cause mortality, target lesion and vessel revascularization (TLR and TVR).
30 days
Adverse cardiac events
Occurrence of adverse cardiac events including all-cause mortality, target lesion and vessel revascularization (TLR and TVR).
12 months
Patients with a PCI using the radial approach and the above radial compression device.
Patients with a PCI using the femoral approach and the above femoral vascular closure device.
First Department of Medicine, University Medical Centre Mannheim
Mannheim, 68167, Germany
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.
600 participants (actual enrollment reported by the registry).
First Submitted
May 14, 2015
First Posted
May 28, 2015
Study Start
February 2014
Actual (reported)Analysis of Myocardial Layer Specific Systolic and Diastolic Function During and After PCI
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
May 2018
Actual (reported)Study Completion
October 2019
Actual (reported)Last Updated
November 1, 2019
Record last verified: 2019-10
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Source: ClinicalTrials.gov.
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