Coronary Artery Disease
Conditions
Keywords
Coronary artery, Drug eluting stent, thrombosis
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.
Interventions
DEVICEBiomatrix Flex Stent
stent implantation
DEVICEInspiron Stent
stent implantation
Sponsors
Scitech Produtos Medicos Ltda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lumen Loss | 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
| Measure | Time frame | Description |
|---|---|---|
| Adverse Cardiac Events | 30 days, 4, 9, 12 months and 2, 3, 4, 5 years after the procedure. | The clinical follow-up should be performed during the index procedure at 30 days, 4, 9, 12 months and 2, 3, 4, 5 years after the procedure, and should consist of an assessment of the angina status (according to the Canadian Cardiovascular Society Classification and the Braunwald for unstable angina) and major adverse cardiac avents and any interventional treatment (e.g: repeated targetlesion revascularization or recurrent ischemia) |
Countries
Brazil
Outcome results
None listed