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

Coronary Artery Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05908422
• Other study ID #: C42102
• Status: Completed
• Start date: January 1, 2023
• Est. completion date: May 15, 2023

Study information

• Verified date: May 2024
• Source: Alvimedica
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 15, 2023
• Est. primary completion date: May 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Vascular Diseases

Intervention

Device:
• Alvision™ Interventional Cardiology Diagnostic Catheter
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.

Locations

Country	Name	City	State
Turkey	Alvimedica	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Alvimedica

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Ratio of the successfully insertion catheter		until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure
Secondary	Capacity of providing the doctor with a safe and effective tool to perform angiographies	Ratio of damage on vessels (%); Ratio of cardiogenic shock (%); Ratio of the straight course of the catheter through the vessels (%)	until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure
Secondary	Duration of the various stages the procedure (before the procedure, during and after the procedure) and a qualitative and quantitative assessment of angiographic quality	Trackability (%); Torquability (%) ,; Slippage (%) ,	until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure
Secondary	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
Secondary	Determination of the relation between catheter size, and patients' height.	catheter size (cm) patients' height (cm)	until discharge from hospital or 24 hours after PCI (Percutaneous Coronary Intervention) procedure