Last updated on February 2018

Second-generation Drug-eluting Stents in Diabetes

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Diabetes Mellitus | Coronary Artery Disease | Coronary heart disease
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria(must meet all):

  • Patients 18 years who understands the nature of the study and provides written informed consent.
  • Diagnosis of diabetes according to the American Diabetes Association diagnostic criteria (*)
  • Documented silent ischemia, stable angina, unstable angina, or myocardial infarction (with or without ST elevation).
  • At least one de novo coronary lesion with stenosis of more than 50% in a vessel with a reference vessel diameter of 2.25 to 4.5 mm by visual estimation. Coronary anatomy is suitable for PCI (patients with potential CABG indication should be eligible for PCI after a multidisciplinary evaluation in a Heart Team).

Exclusion Criteria:

  • Cardiogenic shock or resuscitation
  • Comorbidity with anticipated life expectancy to 24 months
  • Inability to consent due to mechanical ventilation
  • Pregnant female patient
  • Conditions that could preclude a minimal of 1 month of DAPT (such as, but not limited to: severe liver failure, platelet count <100,000 cells/mm3, recent gastrointestinal bleeding or history of bleeding diathesis or coagulopathy)
  • Contraindication or known allergy to aspirin, heparin, P2Y12 inhibitors, cobalt and/or chromium metal alloys, sirolimus or derivates, polyurethane, or contrast media (for contrast-media allergy, patients that might be safely and adequately pre-medicated should be allowed to enter the study).
  • Currently enrolled in another clinical trial.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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