SPAGO: Sirolimus Paclitaxel Angiographic Gain Objective

Prior treatment

• 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)
• 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 undergoing planned surgery within 1 month with the necessity to stop DAPT
• Concurrent medical condition with a life expectancy of less than 12 months
• 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

Other illness

• 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
• Subject suffered from stroke/TIA during the last 6 months
• History of bleeding diathesis or coagulopathy
• The subject is a recipient of a heart transplant

Lab values

• 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)

Other

• The subject is unwilling/not able to return for angiographic re-catheterisation at 12 months follow-up
• Currently participating in another trial
  • Angiographic exclusion criteria:
• Target vessel size \>3.00 mm
• Target vessel size ≤2.00 mm
• 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

• Male or female subjects ≥18 years
• Subject with chronic stable angina or stabilized acute coronary syndromes with normal cardiac biomarker values.
• The subject has at least one de-novo lesion in a small vessel (\>2.00 mm and ≤3.00 mm prior to pre-dilatation) with a diameter stenosis between 50% and 99% (prior to pre-dilatation). It is possible to enroll subjects that have a stent previously implanted in the same epicardial territory (main vessel and ramifications) of the target lesion
• Patients with target lesion to be treated with DCB \< 30 mm in length (up to 40 patients) or with DCB ≥ 30 mm in length (at least 100 patients)
• Able to understand and provide informed consent and comply with all study procedures including 12 months angiographic follow-up
• Subject must have completed the follow-up phase of any previous study