NCT05908422

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

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.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Alvimedica · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease
• Coronary Disease
• Vascular Diseases

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-01-01
• Primary completion: 2023-05-15
• Completion: 2023-05-15
• First posted: 2023-06-18
• Last updated: 2024-05-20

Locations

1 site across 1 country: Turkey (Türkiye)