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

NCT ID: NCT02455661

Last Updated: 2019-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2019-10-31

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Radial PCI with TR Band (TM)

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

Group Type: EXPERIMENTAL

TR Band (TM)

Intervention Type: DEVICE

Femoral PCI with AngioSeal device

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

Group Type: ACTIVE_COMPARATOR

AngioSeal

Intervention Type: DEVICE

Femoral PCI with StarClose device

Group Type: ACTIVE_COMPARATOR

StarClose

Intervention Type: DEVICE

Interventions

TR Band (TM)

Intervention Type: DEVICE

AngioSeal

Intervention Type: DEVICE

StarClose

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitätsmedizin Mannheim

OTHER

Sponsor Role: lead

Responsible Party

Michael Behnes

Sub-PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

First Department of Medicine, University Medical Centre Mannheim

Mannheim, , Germany

Countries

Germany

References

Sartorius B, Behnes M, Unsal M, Hoffmann U, Lang S, Mashayekhi K, Borggrefe M, Akin I. Arterial access-site complications after use of a vascular closure device related to puncture height. BMC Cardiovasc Disord. 2017 Feb 16;17(1):64. doi: 10.1186/s12872-017-0484-7.

Reference Type: DERIVED

PMID: 28209184 (View on PubMed)

Fastner C, Behnes M, Unsal M, El-Battrawy I, Ansari U, Mashayekhi K, Hoffmann U, Lang S, Kuschyk J, Borggrefe M, Akin I. Clinical outcomes of femoral closure compared to radial compression devices following percutaneous coronary intervention: the FERARI study. Heart Vessels. 2017 May;32(5):520-530. doi: 10.1007/s00380-016-0901-3. Epub 2016 Nov 1.

Reference Type: DERIVED

PMID: 27803954 (View on PubMed)

Other Identifiers

2014-560N-MA

Identifier Type: -

Identifier Source: org_study_id