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CHANGE TO ANOTHER PLATFORM IN STUDY.
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| Name | Class |
|---|---|
| GSE Biomedical | OTHER |
| Medstent SA de CV. | UNKNOWN |
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This is a First In Man study with the aim to know the safety and effectiveness of a novel bare metal stent (INC-1) in the treatment of de novo coronary lesions in patients with stable coronary angina and unique coronary lessions.
The cost of performing a percutaneous coronary intervention is very variable since a large number of materials and human resources are considered, with the Stent cost being a fundamental factor; in developing countries, the cost this technology represents an important expense for the patient and the health system; which promotes the development of local technology to support the requirement of these devices.
Ischemic heart disease together with cerebral vascular events is the main cause of, adding 15 million deaths per year. Percutaneous revascularization is the gold standard choice in many of the variants of presentation of ischemic heart disease, the implantation of Stents is the most used method.
Nowadays more and more countries start their own research and development of novel devices in order to reduce cost.
Research question: Is the INC1 Bare Metal Stent safe and effective for the treatment of de novo coronary lesions in humans? Hypothesis: The INC1 Bare-metal Stent is safe and effective for the treatment of de novo coronary lesions in humans
The INC1 Bare metal Stent is a 70uCoCr
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INC1-Bare metal stent | Experimental | Percutaneous coronary implantation of the device (Stent INC-1) following the standard procedure of stent placement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stent INC1 | Device | Coronary intervention with conventional angioplasty technique but with a novel bare metal stent. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of late lumen loss [Safety and Tolerability]) | The primary endpoint of the study is angiographic in-stent late lumen loss (LLL), defined as the difference between the post-procedural minimal lumen diameter (MLD) in the stented segment and the MLD in the same segment at follow-up measured by the angiography laboratory. | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Need of Revascularization | The Need of Revascularization of the treated vessel with a new angioplasty | 9 months |
| MACE | To evaluate the presence of major adverse cardiovascular events such (MACE) as cardiac death, myocardial infarction, new angina event or revascularization through surgery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gian Manuel Jiménez RodrÃguez | Interventional Cardiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Nacional de CardiologÃa | Mexico City | 14080 | Mexico |
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| 9 months |
| Hyperplasia | To evaluate the degree of neointimal hyperplasia or at 9 months by intracoronary ultrasound. | 9 months |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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