Clinical trial NCT05908422: The Alvision™ Interventional Cardiology Diagnostic Catheter Post Market Clinical Follow-up (PMCF) Study.
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Coronary Disease
Vascular Diseases
Lead sponsor: Alvimedica
Sponsor class: INDUSTRY
First posted: 2023-06-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population will consist of all patients in which the Alvision™ Interventional Cardiology Diagnostic Catheter is used who meet the study inclusion/exclusion criteria.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Ratio of the successful delivery of radio-opaque media to selected sites in the coronary vascular system.
timeFrame: until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure
measure: 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:
timeFrame: until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure
Secondary outcomes:
measure: Ratio of the successfully insertion catheter
timeFrame: until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure
measure: Capacity of providing the doctor with a safe and effective tool to perform angiographies
timeFrame: until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure
measure: Duration of the various stages the procedure (before the procedure, during and after the procedure) and a qualitative and quantitative assessment of angiographic quality
timeFrame: until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure
measure: Ratio of the total volume of radio-opaque media delivered to the planned amount of using volume
timeFrame: until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure
measure: Determination of the relation between catheter size, and patients' height.
timeFrame: until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Alvimedica
Study officials:
References: