Coronary Artery Disease, Coronary Disease, Vascular Diseases
Conditions
Brief summary
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.
Interventions
DEVICEFLUYDO 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.
Sponsors
CID S.p.A.
Alvimedica
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Successful inflation, achievement of appropriate diameter, and deflation of the balloon | 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 |
| Device success | immediately after interventional procedure |
| Decrease in the percent stenosis after balloon procedure | immediately after interventional procedure |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
Countries
Turkey (Türkiye)
Outcome results
None listed