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
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Scitech Produtos Medicos Ltda
- Enrollment
- 170
- Locations
- 10
- Primary Endpoint
- Lumen Loss
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief 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.
Detailed 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age \> 18 years;
- •Symptomatic ischemic heart disease and / or objective evidence of myocardial ischemia with one or two target lesions located in different epicardial vessels;
- •A(s) lesion(s) to target(m) must be:
- •Again (not restenotic);
- •Located in a native coronary artery diameter from 2.5 to 3.5 mm (visual);
- •Can be treated with a single stent up to 29 mm in length;
- •Obstruction with stenosis \> 50% diameter (visual);
- •Acceptable candidate for CABG;
- •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
- •Women of childbearing age with no history of surgical sterilization;
- •Myocardial infarction with Q wave occurred in the last 48 hours before the index procedure;
- •Myocardial infarction with or without Q wave with cardiac markers even at high levels;
- •Ejection fraction \< 30%;
- •Impaired renal function (creatinine\> 2.0 mg / dl) or calculated creatinine clearance \< 60 ml / min;
- •Platelet count \<100,000 cells/mm3 or \> 700,000 cells/mm3;
- •Total leukocyte count \<3000 cells/mm3;
- •Documented or suspected liver disease (including laboratory evidence of hepatitis);
- •Heart transplant recipient;
- •Known allergies to aspirin, clopidogrel, ticlopidine, paclitaxel, sirolimus, heparin or stainless steel;
Outcomes
Primary Outcomes
Lumen Loss
Time Frame: 9 months after the procedure
For an accurate assessment of the stent conditions 9 months after implantation, a follow-up catheterization will be performed at the 9 months visit in order to measure the diameter of the artery at the stented site. 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.
Secondary Outcomes
- Adverse Cardiac Events(30 days, 4, 9, 12 months and 2, 3, 4, 5 years after the procedure.)