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

Universitätsmedizin Mannheim600 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

600

Conditions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 30 days

Adverse cardiac events

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