destiny trial (inspiron x biomatrix)

Conditions: Coronary Artery Disease

Summary: 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.

Eligibility criteria:
inclusion criteria: 1. age \> 18 years; 2. symptomatic ischemic heart disease and / or objective evidence of myocardial ischemia with one or two target lesions located in different epicardial vessels; 3. a(s) lesion(s) to target(m) must be: 1. again (not restenotic); 2. located in a native coronary artery diameter from 2.5 to 3.5 mm (visual); 3. can be treated with a single stent up to 29 mm in length; 4. obstruction with stenosis \> 50% diameter (visual); 4. acceptable candidate for cabg; 5. the patient will be informed of the nature of the study, agree with their rules and provide a written informed consent approved by the local ethics committee. exclusion criteria: 1. women of childbearing age with no history of surgical sterilization; 2. myocardial infarction with q wave occurred in the last 48 hours before the index procedure; 3. myocardial infarction with or without q wave with cardiac markers even at high levels; 4. ejection fraction \< 30%; 5. impaired renal function (creatinine\> 2.0 mg / dl) or calculated creatinine clearance \< 60 ml / min; 6. platelet count \ 700,000 cells/mm3; 7. total leukocyte count \<3000 cells/mm3; 8. documented or suspected liver disease (including laboratory evidence of hepatitis); 9. heart transplant recipient; 10. known allergies to aspirin, clopidogrel, ticlopidine, paclitaxel, sirolimus, heparin or stainless steel; 11. patient with a life expectancy less than 12 months; 12. any significant medical condition which in the opinion of the investigator would interfere with the ideal of patient participation in this study; 13. participation in other research in the last 12 months, unless there is direct benefit to the research subject; 14. coronary angioplasty (with or without stenting) for less than 6 months anywhere in the target vessel; 15. coronary angioplasty (with or without stenting) prior to any time in that segment diste less than 5 mm (proximal or distal) of the lesion; 16. coronary angioplasty (with or without stenting) scheduled in the first 12 months after the index procedure in any segment of the target vessel. exclusion criteria angiographic 1. restenotic target lesion; 2. need for treatment for more than one lesion in the same vessel; 3. need for treatment with three or more lesions in the same procedure; 4. target vessel diameter \ 3.5 mm (visual); 5. target lesion long not susceptible to treatment with a single stent to 29mm in length, according to the judgment of the operator; 6. lesion of the coronary artery unprotected ( \> 50% stenosis); 7. angiographic thrombus; 8. target lesion in surgical graft; 9. total occlusion (timi anterograde flow 0 or 1); 10. ostial lesion; 11. the target lesion bifurcation with side branch that may require intervention during the procedure, with or without stenting; 12. injuries that are impossible to anticipate predilatation successfully or that is necessary to use rotablator; 13. the target vessel with excessive tortuosity.

Keywords: coronary artery drug eluting stent thrombosis