The objective of this prospective observational study is to collect clinical data on the medical device Alvision™ Interventional Cardiology Diagnostic Catheter in an unselected population in the current clinical practice
Within the scope of this observational medical device trial, brand/model of the catheter that will be used during the PCI will be decided by the physician and decision of the physician won't be interfered. PCI will be performed according to the standard clinical procedures. Data of the patients to whom Alvision™ Interventional Cardiology Diagnostic Catheter is applied will be gathered for the purpose of this study.
Study Type
OBSERVATIONAL
Enrollment
100
The Alvision™ Interventional Cardiology Diagnostic Catheter is a single use only, thin, flexible single lumen tube, with a proximal hub, sterilized with ethylene oxide (EO) gas, non-pyrogenic. The product is defined as a catheter to inject a contrast medium into selected blood vessels.
Alvimedica
Istanbul, Turkey (Türkiye)
Ratio of the successful delivery of radio-opaque media to selected sites in the coronary vascular system.
Time frame: until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure
Major adverse cardiovascular events (MACEs) and stroke associated with the use of diagnostic catheters until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure, whichever happens first:
* Thrombus formation/emboli * Arterial wall damage * Myocardial infarction * Plaque dislodgement * Cardiac arrhythmia * Death * Stroke
Time frame: until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure
Ratio of the successfully insertion catheter
Time frame: until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure
Capacity of providing the doctor with a safe and effective tool to perform angiographies
* Ratio of damage on vessels (%) * Ratio of cardiogenic shock (%) * Ratio of the straight course of the catheter through the vessels (%)
Time frame: until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure
Duration of the various stages the procedure (before the procedure, during and after the procedure) and a qualitative and quantitative assessment of angiographic quality
* Trackability (%) * Torquability (%) , * Slippage (%) ,
Time frame: until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure
Ratio of the total volume of radio-opaque media delivered to the planned amount of using volume
Time frame: until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure
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Determination of the relation between catheter size, and patients' height.
catheter size (cm) patients' height (cm)
Time frame: until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure