3 rezultatima
DEDICATE Registry:
DRUG ELUTING STENT FOR DIABETIC PATIENTS IN CORONARY ARTERY DISEASE TREATMENT
A POST MARKET REGISTRY OF ABLUMINUS® SIROLIMUS ELUTING CORONARY STENT SYSTEM FOR PERCUTANEOUS INTERVENTION IN PATIENTS WITH DIABETES MELLITUS
Version 1.0
Principal Investigator Dr. Luca Testa, MD, PhD
Each subject will receive one infusion of autologous, radiolabeled and BioRBC labeled INTERCEPT RBCs (Test RBCs) and one infusion of autologous BioRBC labeled untreated RBCs (Control RBCs) concomitantly. Each infusion will be approximately 20 mL, i.e., 10 mL of 51-chromium labeled RBC, and 10 mL of
1. GENERALITIES
1.1 Clinical grade production of cRBC In this study the cRBC is both the active principle and the final product subjected to radioactive chromium labeling.
The quantity of 5x109 cRBC to be reinjected is determined by the necessity to have a quantity of radioactivity lying between