SPAGO: Sirolimus Paclitaxel Angiographic Gain Objective

Exclusion Criteria23

• Subject is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential)
• Evidence of ongoing acute myocardial infarction (AMI) in ECG and/or elevated cardiac biomarkers (according to local standard hospital practice) have not returned within normal limits at the time of procedure
• Known contraindication or hypersensitivity to sirolimus, paclitaxel, or to medications such as aspirin, heparin, and all of the following four medications: clopidogrel bisulfate, ticlopidine, prasugrel, ticagrelor
• Subjects who experienced a previous PCI with DCB in the epicardial territory (main vessel and ramifications) where the target lesion is located, during the last 12 months
• Subject suffered from stroke/TIA during the last 6 months
• LVEF <30%
• Platelet count <100,000 cells/mm3 or >400,000 cells/mm3, a WBC of <3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis)
• Known renal insufficiency (e.g. serum creatinine >2,5 mg/dL, creatinine clearance ≤30 mL/min or eGFR ≤30 mL/min/m2), or subject on dialysis, or acute kidney failure (as per physician judgment)
• Subject undergoing planned surgery within 1 month with the necessity to stop DAPT
• History of bleeding diathesis or coagulopathy
• The subject is a recipient of a heart transplant
• Concurrent medical condition with a life expectancy of less than 12 months
• The subject is unwilling/not able to return for angiographic re-catheterisation at 12 months follow-up
• Currently participating in another trial
• Target vessel size >3.00 mm
• Target vessel size ≤2.00 mm
• Target lesion has a diameter stenosis < 50% prior to pre-dilatation
• Target lesion has a total occlusion or TIMI flow < 2 prior to pre-dilatation
• Pre-dilatation of the target lesion not performed or not successful (residual stenosis > 30%, TIMI flow < 3 and presence of major angiographic dissections)
• Target lesion in left main stem
• The target vessel contains visible thrombus
• Aorto-ostial target lesion (within 3 mm of the aorta junction)
• Lesion is located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft