DESTINY TRIAL (Inspiron x Biomatrix)
This trial is active, not recruiting.
|Condition||coronary artery disease|
|Treatments||inspiron stent, biomatrix flex stent|
|Sponsor||Scitech Produtos Medicos Ltda|
|Start date||May 2013|
|End date||September 2014|
|Trial size||170 participants|
|Trial identifier||NCT01856088, Scitech 004|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Salvador, Brazil||Hospital Santa Izabel||no longer recruiting|
|Goiânia, Brazil||Encore - Cardiologia e Radiologia Intervencionista||no longer recruiting|
|Curitiba, Brazil||Hospital Cardiologico Costantini||no longer recruiting|
|Porto Alegre, Brazil||Instituto de Cardiologia do Rio Grande do Sul||no longer recruiting|
|São Paulo, Brazil||Hospital Bandeirantes de São Paulo||no longer recruiting|
|São Paulo, Brazil||Instituto Dante Pazzanese de Cardiologia||no longer recruiting|
|São Paulo, Brazil||Instituto de Assistência Médica ao Servidor Publico Estadual||no longer recruiting|
|São Paulo, Brazil||Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP||no longer recruiting|
|São Paulo, Brazil||Santa Casa de Misericórdia de São Paulo||no longer recruiting|
|São Paulo, Brazil||Hospital Santa Marcelina||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Stent Inspiron with Sirolimus
Stent Biomatrix Flex with biolimus
time frame: 9 months after the procedure
Adverse Cardiac Events
time frame: 30 days, 4, 9, 12 months and 2, 3, 4, 5 years after the procedure.
Male or female participants at least 18 years old.
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.
|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|
|Principal investigator||Pedro Lemos|
|Description||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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