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

NCT05908422 | Completed

• 1 other identifier: C42102
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Coronary Artery Disease; Coronary Disease; Vascular Diseases

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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

  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.

  until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Alvimedica: lead

Study Sites (1)

Alvimedica

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Disease; Vascular Diseases

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: June 18, 2023
• Study Start: January 1, 2023
• Primary Completion: May 15, 2023
• Study Completion: May 15, 2023
• Last Updated: May 20, 2024

Record last verified: 2024-05

Locations

TU (1)