Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective this study is evaluate the performance and safety of Chronus® cobalt-chromium coronary stent in patients with "de novo" native coronary artery lesions treated with 19-mm-long stents in long-term 9 months.
The use of coronary stents has optimized the results of coronary balloon angioplasty for two reasons:
Cronus® stent is fabricated in cobalt-chromium. This alloy is currently used cardiovascular stents and permanent implants in orthopedic (hips, knees), dental and maxillofacial surgeries. Guidant and Medtronic have conducted clinical evaluations of stents fabricated with a similar cobalt-chromium alloy and demonstrated safety and efficacy of the investigational devices. Both stents are currently available in the European market.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stent implantation | Experimental | Cronus Stent implantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stent implantation | Device | Stent implantation |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Follow-up | All patients are invited to return for a clinical visit at 30 days post-procedure to evaluate possible adverse events and on the continuity of cardiac medication. | 30 days after the procedure |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Angiography Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Fausto Feres, Medicine | Instituto Dante Pazzanese de Cardiologia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital São Salvador Goiânia | Goiânia | Goiás | 74110-020 | Brazil | ||
| Hospital Santa Genoveva |
Not provided
| Label | URL |
|---|---|
| Sponsor site | View source |
| National Information System on Ethics in Research involving Human | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D017130 | Angioplasty |
| ID | Term |
|---|---|
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Goiânia |
| Goiás |
| 74670-430 |
| Brazil |
| Irmandade Santa Casa de Misericórdia de Belo Horizonte | Belo Horizonte | Minas Gerais | Brazil |
| Hospital Santa Isabel | Blumenau | Santa Catarina | 89010-906 | Brazil |
| Instituto Dante Pazzanese de Cardiologia | São Paulo | São Paulo | 04012-909 | Brazil |
| Instituto de Assistência Médica ao Servidor Público Estadual - Iamspe | 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 São Paulo - UNIFESP | São Paulo | São Paulo | Brazil |
| São Bernardo Apart Hospital | Colatina - ES | 29700-790 | Brazil |
| Santa Casa de Franca | Franca - SP | 14400-730 | Brazil |
| Hospital Vera Cruz | Patos de Minas - MG | 38700-160 | Brazil |
| Instituto de Medicina Integral Professor Fernando Figueira - IMIP | Recife - PE | 50070-050 | Brazil |
| Santa Casa de Misericórdia de São José do Rio Preto | São José Do Rio Preto - SP | Brazil |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D013504 |
| Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D008919 | Investigative Techniques |