Access Site Bleeding, Adverse Cardiac Events, Arterial Closure Device, Percutaneous Coronary Intervention (PCI)
Conditions
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.
Interventions
DEVICETR Band (TM)
DEVICEAngioSeal
DEVICEStarClose
Sponsors
Universitätsmedizin Mannheim
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Radial closure by TR-Band.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 30 days | Occurrence of adverse cardiac events including all-cause mortality, target lesion and vessel revascularization (TLR and TVR). |
Countries
Germany
Outcome results
None listed