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| Name | Class |
|---|---|
| CID S.p.A. | INDUSTRY |
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The aim of the present observational study is to collect clinical data on the medical device non-implantable medical device Fluydo NC: coronary angioplasty non-compliant balloon dilatation catheter in the daily use in a not selected population.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FLUYDO NC percutaneous transluminal coronary angioplasty balloon catheter | Device | The FLUYDO NC is a rapid exchange percutaneous transluminal non-compliant coronary angioplasty balloon catheter. It is a single use only medical device, non-implantable, non-pyrogenic and sterilized with ethylene oxide and CO2 mixture. The distal portion has a hydrophilic coating and consists of two lumens: one for balloon inflation and deflation, the other for guidewire advancement and retraction. The product is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. |
| Measure | Description | Time Frame |
|---|---|---|
| Device success | immediately after interventional procedure | |
| Successful inflation, achievement of appropriate diameter, and deflation of the balloon | immediately after interventional procedure | |
| Decrease in the percent stenosis after balloon procedure | immediately after interventional procedure | |
| No perforation, flow-limiting dissection or reduction in Thrombolysis in Myocardial Infarction (TIMI) flow grade | immediately after interventional procedure | |
| No life-threatening arrhythmias (sustained ventricular tachycardia, ventricular fibrillation) | immediately after interventional procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural success: Measurement: Percentage of device success without major adverse cardiovascular events (MACE) (composite of all death, myocardial infarction (MI), and clinically indicated target lesion revascularization (CI-TLR)) | Discharge or 48 hours after index procedure, whichever happens first | |
| Rate of Target Lesion Failure (TLF) Measurement: Percentage of a composite of cardiac death, target vessel myocardial infarction (TV-MI), and CI-TLR. |
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Inclusion Criteria:
Exclusion Criteria:
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Consecutive patients meeting the patient selection criteria, over 18 years old, eligible for a catheter with FLUYDO NC catheter.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alvimedica | Istanbul | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D003327 | Coronary Disease |
| D014652 | Vascular Diseases |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
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| discharge or 48 hours after index procedure, whichever happens first |
| D001157 |
| Arterial Occlusive Diseases |