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

Completed

• Conditions: Coronary Artery Disease; Coronary Disease; Vascular Diseases

• Registration Number: NCT05908422
• Lead Sponsor: Alvimedica

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 Timeline

• Study Start: 2023-01-01
• Primary Completion: 2023-05-15
• Study Completion: 2023-05-15
• Study First Submitted: 2023-05-30
• Study First Submitted QC: 2023-06-08
• Study First Posted: 2023-06-18
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-17
• Last Update Posted: 2024-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	* 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.	until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure

Secondary Outcome Measures

Name	Time	Method
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	* Ratio of damage on vessels (%); * Ratio of cardiogenic shock (%); * Ratio of the straight course of the catheter through the vessels (%)
Determination of the relation between catheter size, and patients' height.	until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure	catheter size (cm) patients' height (cm)
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	* Trackability (%); * Torquability (%) ,; * Slippage (%) ,

Trial Locations

Locations (1)

Alvimedica; 🇹🇷 Istanbul, Turkey