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Completed

NCT Number: NCT02455661

Femoral Closure Versus Radial Compression Devices Related to Percutaneous Coronary Interventions 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.

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Key information

Conditions

Arterial Closure Device Access Site Bleeding Adverse Cardiac Events Cardiovascular Diseases Percutaneous Coronary Intervention (PCI)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

First Department of Medicine, University Medical Centre Mannheim

Mannheim, 68167, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TR Band (TM)

Device

AngioSeal

Device

StarClose

Device

Primary outcomes

  1. 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

  2. Adverse cardiac events

    Time frame: 30 days

    Occurrence of adverse cardiac events including all-cause mortality, target lesion and vessel revascularization (TLR and TVR).

  3. Adverse cardiac events

    Time frame: 12 months

    Occurrence of adverse cardiac events including all-cause mortality, target lesion and vessel revascularization (TLR and TVR).

Sponsors and collaborators

Lead sponsor

Universitätsmedizin Mannheim

Other

Registry information

Acronym: FERARI

Important dates

Study start
2014
Primary completion
2018
Study completion
2019
First posted
May 28, 2015
Registry last updated
Nov 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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