Femoral Closure Versus Radial Compression Devices Related to Percutaneous Coronary Interventions Study (FERARI)

October 30, 2019 updated by: Michael Behnes, Universitätsmedizin Mannheim

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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Mannheim, Germany, 68167
        • First Department of Medicine, University Medical Centre Mannheim

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Device: TR Band (TM)
Active Comparator: Femoral PCI with AngioSeal device
Patients with a PCI using the femoral approach and the above femoral vascular closure device.
Device: AngioSeal
Active Comparator: Femoral PCI with StarClose device
Device: StarClose

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
30 days
Adverse cardiac events
Time Frame: 30 days
Occurrence of adverse cardiac events including all-cause mortality, target lesion and vessel revascularization (TLR and TVR).
30 days
Adverse cardiac events
Time Frame: 12 months
Occurrence of adverse cardiac events including all-cause mortality, target lesion and vessel revascularization (TLR and TVR).
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsmedizin Mannheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2014

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

October 1, 2019

Study Registration Dates

First Submitted

May 14, 2015

First Submitted That Met QC Criteria

May 24, 2015

First Posted (Estimate)

May 28, 2015

Study Record Updates

Last Update Posted (Actual)

November 1, 2019

Last Update Submitted That Met QC Criteria

October 30, 2019

Last Verified

October 1, 2019

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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