Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alvision™ Interventional Cardiology Diagnostic Catheter | Device | 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. |
| 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: |
| until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure |
| 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 |
|
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
The population will consist of all patients in which the Alvision™ Interventional Cardiology Diagnostic Catheter is used who meet the study inclusion/exclusion criteria.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alvimedica | Istanbul | Turkey (Türkiye) |
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| 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 |
| D001157 |
| Arterial Occlusive Diseases |