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

Study Overview
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Brief Summary
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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
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Arterial Closure Device, Percutaneous Coronary Intervention (PCI), Access Site Bleeding, Adverse Cardiac Events

Intervention / Treatment
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* Device: TR Band (TM)
* Device: AngioSeal
* Device: StarClose


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Radial closure by TR-Band.
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Adverse cardiac events | Occurrence of adverse cardiac events including all-cause mortality, target lesion and vessel revascularization (TLR and TVR). | 30 days | 
| Adverse cardiac events | Occurrence of adverse cardiac events including all-cause mortality, target lesion and vessel revascularization (TLR and TVR). | 12 months |