The FLUYDO NC Post Market Clinical Follow-up Study

Study Overview
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Brief Summary
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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.

Official Title
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Multicenter Prospective Registry in Current Clinical Practice With the Non-compliant Coronary Angioplasty Balloon Catheter. The FLUYDO NC Post Market Clinical Follow-up Study

Conditions
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Coronary Disease, Vascular Diseases, Coronary Artery Disease

Intervention / Treatment
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* Device: FLUYDO NC percutaneous transluminal coronary angioplasty balloon catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Turkish citizen, ≥18 years of age, Has indication for percutaneous transluminal coronary angioplasty (PTCA), Has indication to treat obstructive lesions of a native coronary artery or aortocoronary bypass or needs post dilatation of coronary stent Fluydo NC using in the primary lesion treated during the procedure by the decision physician, Has signed and dated the informed consent. Exclusion Criteria: Has a previous diagnosis of coronary artery spasm in the absence of a significant stenosis. Needs the device use in an unprotected left main coronary artery Device use has not consistent with Instructions for Use. Participating in another medical device or pharmaceutical clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: FLUYDO NC percutaneous transluminal coronary angioplasty balloon catheter|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. |  | discharge or 48 hours after index procedure, whichever happens first |