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

Universitätsmedizin Mannheim

Status: Completed

Conditions: Arterial Closure Device; Access Site Bleeding; Percutaneous Coronary Intervention (PCI); Adverse Cardiac Events

Treatments: Device: AngioSeal; Device: StarClose; Device: TR Band (TM)

Study type: Interventional

Funder types: Other

Identifiers

NCT02455661

2014-560N-MA

Details and patient eligibility

About

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.

Enrollment: 600 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 3 patient groups

Radial PCI with TR Band (TM)

Experimental group

Description:

Patients with a PCI using the radial approach and the above radial compression device.

Treatment:

Device: TR Band (TM)

Femoral PCI with AngioSeal device

Active Comparator group

Description:

Patients with a PCI using the femoral approach and the above femoral vascular closure device.

Treatment:

Device: AngioSeal

Femoral PCI with StarClose device

Active Comparator group

Treatment:

Device: StarClose