Stents Versus PAclitaxel Coated Balloons for Revascularization of CompleX and Small Coronary Vessels (SPARX) Trial

Criteria the registry did not label

• Clinical inclusion criteria:
• Age≥18 years
• Patient with NSTE-ACS or CCS with either symptoms and/or ischemia on non-invasive or invasive testing (i.e. FFR/iFR, CMR, SPECT, PET-CT or stress-echo)
• The patient must be able to understand and provide written informed consent and comply with all study procedures
• Life expectancy of \> 2 years
  • Angiographic inclusion criteria:
• One or more trial target vessel (LAD, CX or RCA, or of their branches) with:
  • Stenosis of ≥70% or
  • Stenosis ≥50% and \<70% (visually assessed) with evidence of ischemia by positive stress test, or FFR ≤0.80, or iFR \<0.90 or IVUS minimum lumen area ≤4.0 mm2
• The target vessel/target lesion matches at least one of the following criteria
  • Small vessel: vessel reference diameter is ≤ 3 mm
  • Long lesions: length ≥ 25 mm
  • Calcified lesion: grade 3 by angiography or confirmed on intravascular imaging
  • Chronic total occlusion (CTO)
  • Bifurcation lesions, including ostial LAD and ostial CX
  • Lesions in diabetic coronary artery disease
  • In-Stent Restenosis (ISR)
• Lesion preparation must be according to the 3rd DCB consensus, with lesions that have:
  • ≤ 30% residual stenosis
  • TIMI (Thrombolysis in Myocardial Infarction) flow grade 3.
  • The absence of flow-limiting dissection (Type A-C allowed only)
  • Clinical exclusion criteria:
• STEMI or cardiogenic shock related to an acute MI within 2 days prior to the index PCI
• Pregnancy or nursing declarations (As per country specific guideline) (a negative pregnancy test is required of women with child-bearing potential within 7 days prior to enrollment)
• LVEF\<30%
• Known contraindication or hypersensitivity to any limus family drugs, paclitaxel, or to medications such as heparin, aspirin, clopidogrel, ticlopidine, prasugrel and ticagrelor or any component of the devices.
• Allergy to imaging contrast media which cannot be adequately pre-medicated
• Stroke/TIA during the last 6 months, or any prior intracranial hemorrhage
• Active peptic ulcer or upper gastrointestinal bleeding within last 6 months
• Known renal insufficiency with an eGFR\<30 ml/min1.73m2, or subject on dialysis, or acute renal failure (as per physician judgment)
• Planned surgery within 6 months with the necessity to stop DAPT
• History of bleeding diathesis or coagulopathy
• Platelet count\<100.000 cells/mm3 or \>400.000 cells/mm3, a WBC of \<3000 cells/mm3, documented or suspected liver disease (including laboratory evidence of hepatitis)
• Patient is a recipient of a heart transplant
• Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation
  • Angiographic exclusion criteria:
• Target lesion is in the left main coronary artery
• Target lesion is in a coronary artery bypass graft
• Flow limiting target vessel thrombus
• Evidence of aneurysm in target vessel within 10 mm of the target lesion
• Aorto-ostial target lesion (within 3 mm of the aorta junction)