AngioSeal Versus Radial Approach in Acute Coronary Syndrome
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Intervention: Percutaneous coronary intervention
Intervention description: Both transradial and transfemoral coronary angiography will be performed by the Judkins technique using arterial introducers with 6 French diameter and pre-molded catheters for selective catheterization of left and right coronary arteries.Percutaneous coronary intervention will be indicated when a culprit lesion is identified, with stenosis diameter severity ≥ 70%, with high probability of angiographic success, being ideally performed immediately after coronary angiography and left ventriculography. Patients with multiarterial coronary disease will be submitted to percutaneous coronary intervention after agreement among cardiologist, interventional cardiologist and thoracic surgeon. Procedures will be performed according to recommendations and provisions of current guidelines.
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 240.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Transradial Approach; Transfemoral Approach; Vascular Closure Device

Summary:

      Among non-ST-segment elevation acute coronary syndrome patients submitted to early invasive
      strategy and randomized for the transfemoral or transradial approach, the AngioSeal vascular
      closure device would decrease the prevalence of vascular complications at puncture site,
      reaching the non-inferiority criterion when compared to the radial access.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Non-ST-segment elevation ACS 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 of 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, or transient ST segment elevation,
             or ST segment elevation ≤ 1 mm, or T wave inversion > 2 mm in at least 2 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 markers
             changes, however with previous documentation of coronary atherosclerotic disease
             (CAD), confirmed by previous hospitalization due to AMI, previous percutaneous or
             surgical myocardial revascularization procedure, significant CAD confirmed by coronary
             angiography, or positive functional test for myocardial ischemia];

          -  Intention to submit patient to early invasive strategy consisting of coronary
             angiography immediately followed by PCI, when applicable, in the first 72 hours after
             admission;

          -  Signed informed consent;

          -  Patient eligible for transradial and transfemoral coronary angiography and PCI, being
             pre-requisites: (a) palpable radial artery with normal Allen test or/and 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 or direct thrombin inhibitors, or oral Xa-factor
             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 disease preventing the use of the femoral
             technique;

          -  Severe concomitant disease with life expectancy below 12 months;

          -  Participation in drug or devices investigative clinical trials in the last 30 days;

          -  Indication of elective percutaneous coronary intervention to be performed in a moment
             different from immediately after coronary angiography;

          -  Medical, geographic or social conditions impairing the participation in the study or
             inability to understand and sign the informed consent term.