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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- 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:
Study Overview
Brief Summary
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
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 Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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:
Time Frame: until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure
* Thrombus formation/emboli * Arterial wall damage * Myocardial infarction * Plaque dislodgement * Cardiac arrhythmia * Death * Stroke
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
Secondary Outcomes
- Ratio of the successfully insertion catheter(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)
- Capacity of providing the doctor with a safe and effective tool to perform angiographies(until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure)
- Determination of the relation between catheter size, and patients' height.(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)