Study: NCT02384070

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: FFR
Description: Fractional flow reserve tracings were calculated using a Volcano pressure wire intra-coronary system after ensuring proper calibration of the aortic pressure transducer and the guidewire, using 6 Fr-guide catheters. Before crossing the stenosis, baseline pressure was measured by the guide catheter and the pressure guidewire were equalized according to the manufacturer's specifications. After advancing the pressure sensor across the stenosis, coronary hyperemia was induced using intravenous adenosine (140μg/kg/min until a steady state was reached for at least 3 minutes). Fractional flow reserve was considered positive if it was less than 0.80.

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: FFR
Description: Fractional flow reserve tracings were calculated using a Volcano pressure wire intra-coronary system after ensuring proper calibration of the aortic pressure transducer and the guidewire, using 6 Fr-guide catheters. Before crossing the stenosis, baseline pressure was measured by the guide catheter and the pressure guidewire were equalized according to the manufacturer's specifications. After advancing the pressure sensor across the stenosis, coronary hyperemia was induced using intravenous adenosine (140μg/kg/min until a steady state was reached for at least 3 minutes). Fractional flow reserve was considered positive if it was less than 0.80.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: FFR
Description: Fractional flow reserve tracings were calculated using a Volcano pressure wire intra-coronary system after ensuring proper calibration of the aortic pressure transducer and the guidewire, using 6 Fr-guide catheters. Before crossing the stenosis, baseline pressure was measured by the guide catheter and the pressure guidewire were equalized according to the manufacturer's specifications. After advancing the pressure sensor across the stenosis, coronary hyperemia was induced using intravenous adenosine (140μg/kg/min until a steady state was reached for at least 3 minutes). Fractional flow reserve was considered positive if it was less than 0.80.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Aspirin
Description: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Aspirin
Description: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Aspirin
Description: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Clopidogrel
Description: All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Clopidogrel
Description: All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Bivalirudin
Description: Dosed based on the weight at 0.75 mg/kg I.V. bolus dose followed by a 1.75 mg/kg/hr I.V. infusion for the duration of the procedure

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Bivalirudin
Description: Dosed based on the weight at 0.75 mg/kg I.V. bolus dose followed by a 1.75 mg/kg/hr I.V. infusion for the duration of the procedure