Thromboaspiration in Patients With High Thrombotic Burden Undergoing Primary Percutaneous Coronary Intervention (PCI)
Condition: Primary PCI for STEMI
Intervention: coronary thrombectomy; standard primary PCI (with stenting, as required)
Intervention description: coronary thrombectomy with either Angiojet device (rhelytic thrombectomy) or Export device (manual aspiration); standard primary PCI (usually with stenting) for STEMI, without use of thrombectomy or distal protection devices
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 208.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      200 consecutive patients presenting with STEMI within 12 hours from the onset of symptoms and
      having a high thrombotic burden at coronary angiography, defined as the presence of a
      thrombus size ≥ 2 times the diameter of the vessel, according to a visual estimate. The main
      objective of the study is to evaluate the effectiveness of thrombectomy (either rheolytic or
      manual aspiration) as an adjunct to primary or rescue angioplasty, in patients with
      angiographic evidence high thrombotic burden in the culprit artery. Primary end points: (1)
      rate of complete ST-segment elevation resolution at 60 minutes after the end of the
      procedure; (2) infarct size as assessed by delayed-enhancement cardiac magnetic resonance
      imaging (DE-MRI) at 3 months after the index procedure.

      Secondary endpoints: post-procedural TIMI flow grade; post-procedural MBG; infarct
      transmurality at 3 months; MVO at 3 months; 1-year actuarial freedom from MACEs.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Prolonged, continuous signs and symptoms of ischemia lasting more than 20 min,
             starting within 12 hours prior to randomization, and ST elevation ≥ 2mm in ≥2
             contiguous ECG leads, or new left bundle branch block (LBBB)

          2. Presence of high thrombotic burden in the culprit lesion at diagnostic angiography
             (defined as the presence of a thrombus size ≥ 2 times the diameter of the vessel,
             according to a visual estimate, or abrupt cut-off occlusion of a coronary artery ≥3 mm
             in reference vessel diameter)

          3. Written informed consent

        Exclusion Criteria:

          -  Low-risk (ST elevation in ≤2 leads) inferior AMI

          -  Previous infarction in the same area (assessed by ECG)

          -  PCI in the 2 weeks prior to AMI

          -  Active internal bleeding

          -  History of cerebrovascular accident in the previous 2 years or cerebrovascular
             accident with a significant residual neurological deficit

          -  Head or spine surgery or trauma in the previous 2 months

          -  Recent (within six weeks) gastrointestinal (GI) or genitourinary (GU) bleeding of
             clinical significance

          -  Administration of oral anticoagulants within seven days unless prothrombin time is
             <1.2 times control

          -  Bleeding diathesis or severe uncontrolled arterial hypertension

          -  Thrombocytopenia (<100 000 cells/mL)

          -  Recent (within six weeks) major surgery or trauma

          -  Intracranial neoplasm, arteriovenous malformation, or aneurysm

          -  Severe renal or liver failure

          -  Allergy to aspirin

          -  Contraindication to MRI examination

          -  Pregnancy and lactation