The Alvision™ Interventional Cardiology Diagnostic Catheter Post Market Clinical Follow-up (PMCF) Study.

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Alvision™ Interventional Cardiology Diagnostic Catheter Use for Routine Diagnostic Procedures in Angiographic Applications: Evaluation of Safety and Performance in Everyday Clinical Practice. The Alvision™ Interventional Cardiology Diagnostic Catheter Post Market Clinical Follow-up (PMCF) Study.

Conditions
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Coronary Artery Disease, Coronary Disease, Vascular Diseases

Intervention / Treatment
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* Device: Alvision™ Interventional Cardiology Diagnostic Catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Turkish citizen, ≥18 years of age, Has indication for a diagnostic coronarography according to Alvision™ Instruction for use, Has signed and dated the informed consent. Exclusion Criteria: Having a known allergic reaction to any of the composition of Alvision™ Interventional Cardiology Diagnostic Catheter. Has synthetic vascular grafts through which the Alvision™ Interventional Cardiology Diagnostic Catheter should pass 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: Alvision™ Interventional Cardiology Diagnostic Catheter|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ratio of the successful delivery of radio-opaque media to selected sites in the coronary vascular system. |  | 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 | until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ratio of the successfully insertion catheter |  | 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 (%) | 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 (%) , | 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 |  | until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure | 
| Determination of the relation between catheter size, and patients' height. | catheter size (cm) patients' height (cm) | until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure |