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

• Sponsor: Universitätsmedizin Mannheim (Other)
• Overall Status: Completed
• CT.gov ID: NCT02455661
• Collaborator: (none)
• Enrollment: 600
• Location: 1
• Arms: 3
• Actual Duration (Months): 67.9
• Patients Per Site Per Month: 8.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Arterial Closure Device; Percutaneous Coronary Intervention (PCI); Access Site Bleeding; Adverse Cardiac Events	Device: TR Band (TM); Device: AngioSeal; Device: StarClose	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 600 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Radial closure by TR-Band.Radial closure by TR-Band.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Actual Study Start Date: Feb 1, 2014
• Actual Primary Completion Date: May 1, 2018
• Actual Study Completion Date: Oct 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Radial PCI with TR Band (TM) Patients with a PCI using the radial approach and the above radial compression device.	Device: TR Band (TM)
Active Comparator: Femoral PCI with AngioSeal device Patients with a PCI using the femoral approach and the above femoral vascular closure device.	Device: AngioSeal
Active Comparator: Femoral PCI with StarClose device	Device: StarClose

Outcome Measures

Primary Outcome Measures

1. 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

2. Adverse cardiac events [30 days]

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

3. Adverse cardiac events [12 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	First Department of Medicine, University Medical Centre Mannheim	Mannheim		Germany	68167

Sponsors and Collaborators

• Universitätsmedizin Mannheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Michael Behnes, Sub-PI, Universitätsmedizin Mannheim
• ClinicalTrials.gov Identifier: NCT02455661
• Other Study ID Numbers: 2014-560N-MA
• First Posted: May 28, 2015
• Last Update Posted: Nov 1, 2019
• Last Verified: Oct 1, 2019

Study Results

No Results Posted as of Nov 1, 2019