CompariSon of Manual Aspiration With Rheolytic Thrombectomy in Patients Undergoing Primary PCI. The SMART-PCI Trial

The SMART Study is an on-label, randomized, 2-arms, prospective study in patients with STEMI undergoing primary PCI. Diagnosis of STEMI is based on ECG evidence of ischemic ST changes, clinical symptoms, and elevated CK and CK-MB cardiac enzymes. Patients who are eligible for the Study and who provide written informed consent will be included in the study.

Inclusion criteria

• Patient is > 18 years of age.
• Patient has ST-segment elevation of at least 0.1 mV in 2 or more contiguous leads or presumably new LBBB for all types of infarcts.
• Patient's AMI presentation is greater than 30 minutes but less than 6 hours after symptom onset.
• Patient provides written informed consent.
• Patient has no childbearing potential or is not pregnant.
• Target artery has a reference vessel diameter of at least 2.5 mm on visual assessment at baseline angiography.

Exclusion criteria

• Known prior history of renal insufficiency (serum creatinine 2.0 mg/dL).
• Cardiogenic shock.
• Prior administration of thrombolysis for the current infarction.
• Participation in another study.
• Major surgery within past 6 weeks.
• History of stroke within 30 days, or any history of hemorrhagic stroke.
• Severe hypertension (systolic BP > 200 mm Hg or diastolic BP > 110 mm Hg) not controlled on antihypertensive therapy.
• Known neutropenia ( <1000 neutrophils per mm3) or known severe thrombocytopenia (< 50,000 platelets per mm3).
• Patient unwilling to receive blood products.
• Previously stented IRA (stent thrombosis).
• Inability to identify the IRA.
• Severe vessel tortuosity that enables OCT assessment.

Inclusion criteria

Clinical inclusion criteria:

• Patient is > 18 years of age.
• Patient has ST-segment elevation of at least 0.1 mV in 2 or more contiguous leads or presumably new LBBB for all types of infarcts.
• Patient's AMI presentation is greater than 30 minutes but less than 6 hours after symptom onset.
• Patient provides written informed consent. Patient has no childbearing potential or is not pregnant

Angiographic inclusion criteria:

• All patients with or without evidence of thrombus are eligible.
• Target artery has a reference vessel diameter 2.5 mm on visual assessment at baseline angiography.

Exclusion criteria

Clinical exclusion criteria:

• Known prior history of renal insufficiency (serum creatinine 2.0 mg/dL).
• Cardiogenic shock.
• Prior administration of thrombolysis for the current infarction.
• Participation in another study.
• Major surgery within past 6 weeks.
• History of stroke within 30 days, or any history of hemorrhagic stroke.
• Severe hypertension (systolic BP > 200 mm Hg or diastolic BP > 110 mm Hg) not controlled on antihypertensive therapy.
• Known neutropenia ( <1000 neutrophils per mm3) or known severe thrombocytopenia (< 50,000 platelets per mm3).
• Patient unwilling to receive blood products

Angiographic exclusion criteria:

• Previously stented IRA (stent thrombosis).
• Inability to identify the IRA.
• Severe vessel tortuosity that enables OCT assessment.