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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inspiron Stent | Experimental | Stent Inspiron with Sirolimus |
|
| Biomatrix Flex Stent | Active Comparator | Stent Biomatrix Flex with biolimus |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inspiron Stent | Device | stent implantation |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Lumen Loss | 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. | 9 months after the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Cardiac Events | 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) |
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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:
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:
EXCLUSION CRITERIA angiographic
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| Name | Affiliation | Role |
|---|---|---|
| Pedro Lemos | Instituto do Coração - Incor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Santa Izabel | Salvador | Estado de Bahia | Brazil | |||
| Encore - Cardiologia e Radiologia Intervencionista |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26352896 | Derived | Lemos PA, Abizaid AA, Meireles GC, Sarmento-Leite R, Prudente M, Cantarelli M, Dourado AD, Mariani J Jr, Perin MA, Costantini C, Costa RA, Costa JR, Chamie D, Campos CA, Ribeiro E. Metallic Limus-Eluting Stents Abluminally Coated with Biodegradable Polymers: Angiographic and Clinical Comparison of a Novel Ultra-Thin Sirolimus Stent Versus Biolimus Stent in the DESTINY Randomized Trial. Cardiovasc Ther. 2015 Dec;33(6):367-71. doi: 10.1111/1755-5922.12159. |
| Label | URL |
|---|---|
| Sponsor site | View source |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017130 | Angioplasty |
| ID | Term |
|---|---|
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
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| Biomatrix Flex Stent | Device | stent implantation |
|
|
| 30 days, 4, 9, 12 months and 2, 3, 4, 5 years after the procedure. |
| Goiânia |
| Goiás |
| Brazil |
| Hospital Cardiologico Costantini | Curitiba | Paraná | Brazil |
| Instituto de Cardiologia do Rio Grande do Sul | Porto Alegre | Rio Grande do Sul | Brazil |
| Hospital Bandeirantes de São Paulo | São Paulo | São Paulo | Brazil |
| Instituto Dante Pazzanese de Cardiologia | São Paulo | São Paulo | Brazil |
| Instituto de Assistência Médica ao Servidor Publico Estadual | São Paulo | São Paulo | Brazil |
| Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP | São Paulo | São Paulo | Brazil |
| Santa Casa de Misericórdia de São Paulo | São Paulo | São Paulo | Brazil |
| Hospital Santa Marcelina | São Paulo | Brazil |
| National Information System on Ethics in Research Involving Human | View source |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D016769 | Embolism and Thrombosis |
| D013504 |
| Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D008919 | Investigative Techniques |