Femoral Closure Versus Radial Compression Devices Related to Percutaneous Coronary Interventions Study
NCT02455661 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600
Last updated 2019-11-01
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
Interventions
- DEVICE
-
TR Band (TM)
- DEVICE
-
AngioSeal
- DEVICE
-
StarClose
Sponsors & Collaborators
-
Universitätsmedizin Mannheim
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-02-28
- Primary Completion
- 2018-05-31
- Completion
- 2019-10-31
Countries
- Germany
Study Locations
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