DESTINY TRIAL (Inspiron x Biomatrix)

Launched by SCITECH PRODUTOS MEDICOS LTDA · May 16, 2013

Keywords

ClinConnect Summary

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 anti...

Gender

ALL

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 \<100,000 cells/mm3 or \> 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 \<2.5 mm or\> 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.