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

Alvimedica

Status: Completed

Conditions: Coronary Artery Disease; Vascular Diseases; Coronary Disease

Treatments: Device: Alvision™ Interventional Cardiology Diagnostic Catheter

Study type: Observational

Funder types: Industry

Identifiers

NCT05908422

C42102

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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