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The objective of this study is to evaluate the security issues and efficacy of coronary stenting Cobalt Chrome covered with sirolimus-eluting Cobalt Chrome platform in patients with coronary artery lesion.
Patients will be treated in compliance with the eligibility criteria, with stent study of 16-19mm. All patients are clinically followed for 60 months after the procedure and will undergo a control angiography 6 months. Can be treated multiple lesions, measuring between 2.5-3.5mm (by visual estimate). Patients enrolled will be randomized in a 1:2 propose in one of the groups with or without stent coating, respectively. And a randomized clinical trial, prospective study in 5 centers including 60 patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BARE METAL STENT | Placebo Comparator | BARE METAL STENT - STENT CRONUS |
|
| DRUG ELUTING STENT | Experimental | STENT INSPIRON WITH SIROLIMUS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DRUG ELUTING STENT | Device | Site preparation and percutaneous access should be performed as per standard hospital procedures.It is recommended to cross the target lesion with 0.014-inch exchange-length guide wire. The involved lesion should be predilated with appropriately sized balloons using standard techniques. It is strongly encouraged that the Investigators use similar materials and techniques throughout the study to maintain consistency and standardization of care.A stent consists of an endovascular prosthesis with a metallic mesh structure that is implanted at the site of the artery blockage via catheterization procedure. The objective of stenting is to obtain an angiographic appearance of the expanded stent only outside the limits of the target vessel filled with contrast medium. |
| Measure | Description | Time Frame |
|---|---|---|
| Lumen Loss | For an accurate assessment of the stent conditions 6 months after implantation, a follow-up catheterization will be performed at the 6-month visit in order to measure the diameter of the artery at the stented site. The objective is the lumen loss in-segment (including the portion in-stent and edges of 5 mm proximal and distal) at 6 months. | 6 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, 6, 12 and 60 months post-procedure, and should consist of an assessment of the angina status (according to the Canadian Cardiovascular Society Classification and the Braunwald Classification for unstable angina) and major adverse cardiac events and any interventional treatment (e.g.: repeated target lesion revascularization or recurrent ischemia). |
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Inclusion Criteria:
Exclusion Criteria:
4.3. ANGIOGRAPHIC EXCLUSION CRITERIA
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| Name | Affiliation | Role |
|---|---|---|
| Expedito E. Ribeiro da Silva, Medicine | Instituto do Coração do Hospital das Clínicas da Fac. de Medicina da USP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Ibiapaba de Barbacena | Barbacena | Minas Gerais | 36201-356 | Brazil | ||
| Instituto de Assistêcia Médica ao Servidor Publico Estadual |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Carlos Augusto Homem de Magalhães Campos; Celso K. Takimura; Guilherme B. Gregores; Carlos A. Sarmento; Emerson T. Fioretto; Fracisco R. M. Laurindo; Expedito E. Ribeiro; Eulógio E. Martinez; Thiago F.C.C. Borges; Pedro A. Lemos. Redução neointimal com Stent com polímero biodegradável e Sirolimus desenvolvido no Brasil: Resultados preliminares em Suínos. Rev. Soc. Cardiol. Estado de São Paulo - Supl. B - Vol. 19 | ||
| 26331110 | Derived | Oliveira MD, Ribeiro EE, Campos CM, Ribeiro HB, Faillace BL, Lopes AC, Esper RB, Meirelles GX, Perin MA, Abizaid A, Lemos PA. Four-year clinical follow-up of the first-in-man randomized comparison of a novel sirolimus eluting stent with abluminal biodegradable polymer and ultra-thin strut cobalt-chromium alloy: the INSPIRON-I trial. Cardiovasc Diagn Ther. 2015 Aug;5(4):264-70. doi: 10.3978/j.issn.2223-3652.2015.07.05. | |
| 24755382 |
| 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 |
|---|---|
| D054855 | Drug-Eluting Stents |
| D000792 | Angiography |
| D015607 | Stents |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
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|
|
| BARE METAL STENT | Device | Site preparation and percutaneous access should be performed as per standard hospital procedures.It is recommended to cross the target lesion with 0.014-inch exchange-length guide wire. The involved lesion should be predilated with appropriately sized balloons using standard techniques. It is strongly encouraged that the Investigators use similar materials and techniques throughout the study to maintain consistency and standardization of care.A stent consists of an endovascular prosthesis with a metallic mesh structure that is implanted at the site of the artery blockage via catheterization procedure. The objective of stenting is to obtain an angiographic appearance of the expanded stent only outside the limits of the target vessel filled with contrast medium. |
|
| 30 days, 6, 12 and 60 months after the procedure |
| São Paulo |
| São Paulo |
| 04029-000 |
| Brazil |
| Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP | São Paulo | São Paulo | 05403-000 | Brazil |
| Hospital Santa Marcelina | São Paulo | São Paulo | 08270-070 | Brazil |
| Derived |
| Ribeiro EE, Campos CM, Ribeiro HB, Lopes AC, Esper RB, Meirelles GX, Perin MA, Abizaid A, Lemos PA. First-in-man randomised comparison of a novel sirolimus-eluting stent with abluminal biodegradable polymer and thin-strut cobalt-chromium alloy: INSPIRON-I trial. EuroIntervention. 2014;9(12):1380-4. doi: 10.4244/EIJV9I12A234. |
| Site about the location that will be done the study. Location where the principal investigator works. | View source |
| National Information System on Ethics in Research involving Human | View source |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D016769 | Embolism and Thrombosis |
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003935 | Diagnostic Techniques, Cardiovascular |