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Abluminus is an abluminally caoted  Sirolimus Drug Eluting Stent which is dedicated for Diabetic and Acute Myocardial Infarction Patients. The stent and the balloon, both are coated with Sirolimus, in a pre-crimped condition which allows to treat diffused disease in coronary artery in Diabetic patients. The stent on 45 sec inflation; develops a thin bio-absorbable film which acts as a protective layer and avoids slow flow – no flow blood movement.

The DEDICATE REGISTRY is designed to establish long term benefits of unique and innovative product design of Abluminus in Diabetic indication globally.

OBJECTIVE

To evaluate the performance of a novel ABLUMINUS® DES+ sirolimus eluting stent in patients with Diabetes Mellitus

DESIGN

Prospective, Observational, Multi‐center clinical registry to be conducted in Europe at Interventional cardiology centers. 1000 patients will be enrolled and evaluated.

All the patients will be followed up for up to 5 years.

PRIMARY ENDPOINTS

Target Lesion Failure, which is composite of cardiac death, target-vessel myocardial infarction, and clinically indicated target lesion revascularization within 12 months

SECONDARY ENDPOINTS

Stent thrombosis [Time Frame: 1 month, 12 months, yearly]: Definite and probable stent thrombosis according to ARC definitions
Cardiac death [Time Frame: 1 month, 12 months, yearly]
Target Vessel Myocardial infarction [Time Frame: 1 month, 12 months, yearly]
Target Lesion Revascularisation [Time Frame: 1 month, 12 months, yearly]
Device Success at 24 hours
Lesion Success at 24 hours
Procedural Success at 24 hours

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Do you face challenges in treating diabetic patients in coronary artery disease?*
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  • Head of Coronary Revascularization Unit
    Head of Clinical Research Unit
    Department of Cardiology,
    IRCCS Policlinico S. Donato, San Donato
    M.ne, Milan, Italy

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    Dedicate Healthcare - Envision Scientific - Advancing Innovation

    Chairman

    Dr. Luca Testa, MD, PhD

  • Interventional cardiologist
    Emodinamica Fondazione
    Poliambulanza istituto ospedaliero, Brescia, Italy

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    Dedicate Healthcare - Envision Scientific - Advancing Innovation

    Co-Chairman

    Dr. Diego Maffeo

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