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

Percutaneous Coronary Intervention (PCI) Clinical Trial

— FERARI  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02455661
• Other study ID #: 2014-560N-MA
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Est. completion date: October 2019

Study information

• Verified date: October 2019
• Source: Universitätsmedizin Mannheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: October 2019
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Access Site Bleeding
• Adverse Cardiac Events
• Arterial Closure Device
• Hemorrhage
• Percutaneous Coronary Intervention (PCI)

Intervention

Device:
• TR Band (TM)

• AngioSeal

• StarClose

Locations

Country	Name	City	State
Germany	First Department of Medicine, University Medical Centre Mannheim	Mannheim

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsmedizin Mannheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Adverse cardiac events	Occurrence of adverse cardiac events including all-cause mortality, target lesion and vessel revascularization (TLR and TVR).	30 days
Primary	Adverse cardiac events	Occurrence of adverse cardiac events including all-cause mortality, target lesion and vessel revascularization (TLR and TVR).	12 months