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Prospective, multicentric, single-arm study to evaluate fast and effective tissue repair in patients undergone percutaneous coronary intervention with drug eluting stent Inspiron.
The first 20 patients enrolled will be evaluated by angiography and Optical Coherence Tomography 3 months after stent implantation. The following 20 patients will be evaluated by the same methods 2 months after the implantation and the last 20 patients after 30 days.
All patients will be clinically followed at 30 days, 6 months, 1 and 2 years after index procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 30 days evaluation | Experimental | Angiography and Optical Coherence Tomography evaluations |
|
| 2 months evaluation | Experimental | Angiography and Optical Coherence Tomography evaluations |
|
| 3 months evaluation | Experimental | Angiography and Optical Coherence Tomography evaluations |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Angiography and Optical Coherence Tomography evaluations | Device | coronary stent implantation followed by Angiography and Optical Coherence Tomography evaluations |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tissue Coverage | Change in the tissue coverage percentage measured by OCT | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| in-stent late lumen loss | in-stent late lumen loss | 3 months |
| Stent Thrombosis | Stent Thrombosis Rates | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Evangélico do Espírito Santo | Vila Velha | Espírito Santo | Brazil | |||
| Hospital do Coração Anis Rassi |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| C535731 | Dysequilibrium syndrome |
| D020163 | Ornithine Carbamoyltransferase Deficiency Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000792 | Angiography |
| ID | Term |
|---|---|
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Target Vessel Failure | Target Vessel Failure (Death, MI and new revascularization) | 2 years |
| Goiânia |
| Goiás |
| Brazil |
| Paraná Medical Research Center | Maringá | Paraná | Brazil |
| Instituto de Cardiologia do Rio Grande do Sul | Porto Alegre | Rio Grande do Sul | Brazil |
| Instituto Dante Pazzanese de Cardiologia | São Paulo | São Paulo | Brazil |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D056806 | Urea Cycle Disorders, Inborn |
| D020739 | Brain Diseases, Metabolic, Inborn |
| D001928 | Brain Diseases, Metabolic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D040181 | Genetic Diseases, X-Linked |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000592 | Amino Acid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D003935 |
| Diagnostic Techniques, Cardiovascular |