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Completed

NCT Number: NCT05908422

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

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

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Alvimedica

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Ratio of the successfully insertion catheter

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

  2. Capacity of providing the doctor with a safe and effective tool to perform angiographies

    Time frame: 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 (%)

  3. Duration of the various stages the procedure (before the procedure, during and after the procedure) and a qualitative and quantitative assessment of angiographic quality

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

    • Trackability (%)
    • Torquability (%) ,
    • Slippage (%) ,

  4. Ratio of the total volume of radio-opaque media delivered to the planned amount of using volume

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

  5. Determination of the relation between catheter size, and patients' height.

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

    catheter size (cm) patients' height (cm)

Sponsors and collaborators

Lead sponsor

Alvimedica

Industry

Registry information

Official study 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.

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 18, 2023
Registry last updated
May 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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