Coronary Artery Disease Clinical Trial
Official title:
Stents Coated With the Biodegradable Polymer on Their Abluminal Faces and Elution of Sirolimus Versus Biolimus Elution for the Treatment of de Novo Coronary Lesions - Destiny Trial
The main objective of this study is to evaluate the effectiveness of stent Inspiron ™ sirolimus-eluting and coating the abluminal biodegradable stent Biomatrix Flex ™ lesions in native coronary arteries.
This is a study of non-inferiority, multicentre, prospective, randomized into two treatment
arms: I) Inspiron ™ stent eluting sirolimus or II) ™ Biomatrix stent eluting biolimus. Are a
total of 165 randomized patients.
Patients will be followed for 60 months after the procedure. All new patients will be
undergoing angiography for evaluation at 9 months. A subgroup of 60 patients will be
evaluated with volumetric intravascular ultrasound at 9 months. Also, a subgroup of 21
patients will be evaluated with optical coherence tomography at the end of the index
procedure and 9 months. It is anticipated that the total study duration is 72 months: 12
months to complete the admission of patients and 60 months of follow-up.
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