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

Not Applicable

Completed

• Conditions: Access Site Bleeding; Arterial Closure Device; Percutaneous Coronary Intervention (PCI); Adverse Cardiac Events
• Interventions: Device: StarClose; Device: AngioSeal; Device: TR Band (TM)

• Registration Number: NCT02455661
• Lead Sponsor: Universitätsmedizin Mannheim

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2015-05-14
• Study First Submitted QC: 2015-05-24
• Study First Posted: 2015-05-28
• Primary Completion: 2018-05
• Status Verified: 2019-10
• Study Completion: 2019-10
• Last Update Submitted: 2019-10-30
• Last Update Posted: 2019-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Femoral PCI with StarClose device	StarClose	-
Femoral PCI with AngioSeal device	AngioSeal	Patients with a PCI using the femoral approach and the above femoral vascular closure device.
Radial PCI with TR Band (TM)	TR Band (TM)	Patients with a PCI using the radial approach and the above radial compression device.

Primary Outcome Measures

Name	Time	Method
Vascular complications at the arterial access site	30 days	Occurrence of vascular complications at the arterial access site including major bleedings as defined by common classification systems
Adverse cardiac events	12 months	Occurrence of adverse cardiac events including all-cause mortality, target lesion and vessel revascularization (TLR and TVR).

Trial Locations

Locations (1)

First Department of Medicine, University Medical Centre Mannheim; 🇩🇪 Mannheim, Germany