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Table 2 Eligibility criteria

From: Design and rationale of the AngioSeal versus the Radial approach In acute coronary SyndromE (ARISE) trial: a randomized comparison of a vascular closure device versus the radial approach to prevent vascular access site complications in non-ST-segment elevation acute coronary syndrome patients

Inclusion criteria Non-ST-segment elevation acute coronary syndrome patients (ischemic symptoms suspicious of non-ST-segment elevation ACS (unstable angina or non-ST-segment elevation AMI) defined as clinical presentation compatible with a new manifestation or worsening of chest pain characteristic of ischemia at rest or at minimum effort, lasting more than 10 minutes, and at least one of the following items: (a) ECG changes compatible with new ischemia (ST-segment depression of at least 1 mm, transient ST-segment elevation, ST-segment elevation ≤ 1 mm or T wave inversion > 3 mm in at least two contiguous shunts); (b) cardiac enzymes (CK-MB or troponin T or I) above the upper normality range limit; (c) patients > 60 years of age without ECG or myocardial necrosis marker changes; however, with previous documentation of coronary atherosclerotic disease, confirmed by previous hospitalization due to AMI, previous percutaneous or surgical myocardial revascularization procedure, significant coronary atherosclerotic disease confirmed by coronary angiography or positive functional test for myocardial ischemia)
  Intention to submit patient to an early invasive strategy consisting of coronary angiography immediately followed by PCI, when applicable, in the first 72 hours after admission
  Patient informed about the nature of the study and agreeing with its general terms and having signed the informed consent, as approved by the Research Ethics Committee of the respective center
  Patient eligible for coronary angiography and both radial and femoral PCI with the following pre-requisites: (a) palpable radial artery with the Allen or normal oximetry tests, (b) familiarity of the operator with the radial and femoral techniques using AngioSeal, (c) agreement of the operator to use the access route determined by the randomization process
Exclusion criteria Less than 18 years of age
  Pregnancy
  Chronic use of vitamin K antagonists, direct thrombin inhibitors or oral factor Xa antagonists
  Hypersensitivity to antiplatelet and/or anticoagulant drugs
  Active bleeding or high bleeding risk (severe liver failure, active peptic ulcer, creatinine clearance < 30 mL/min, platelets count < 100,000 mm3)
  Uncontrolled systemic hypertension
  Cardiogenic shock
  Previous myocardial revascularization surgery with ≥ 1 internal mammary or radial artery graft
  Documented chronic peripheral arterial insufficiency preventing the use of the femoral technique
  Severe concomitant disease with life expectancy below 12 months
  Participation in drug or device investigative clinical trials in the last 30 days
  Indication of elective percutaneous coronary intervention to be performed at a moment different from immediately after coronary angiography
  Medical, geographic or social conditions impairing participation in the study or inability to understand and sign the informed consent term