Status:
COMPLETED
Thromboaspiration in Patients With High Thrombotic Burden Undergoing Primary Percutaneous Coronary Intervention (PCI)
Lead Sponsor:
University of Pisa
Conditions:
Primary PCI for STEMI
Eligibility:
All Genders
18-90 years
Phase:
PHASE4
Brief 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 ti...
Eligibility Criteria
Inclusion
- 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)
- 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)
- Written informed consent
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
208 Patients enrolled
Trial Details
Trial ID
NCT01472718
Start Date
February 1 2009
End Date
March 1 2012
Last Update
February 12 2019
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