The FLUYDO NC Post Market Clinical Follow-up Study

Alvimedica100 enrolled

Overview

The aim of the present observational study is to collect clinical data on the medical device non-implantable medical device Fluydo NC: coronary angioplasty non-compliant balloon dilatation catheter in the daily use in a not selected population.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Coronary Artery Disease Coronary Disease Vascular Diseases

Interventions

FLUYDO NC percutaneous transluminal coronary angioplasty balloon catheterDEVICE

The FLUYDO NC is a rapid exchange percutaneous transluminal non-compliant coronary angioplasty balloon catheter. It is a single use only medical device, non-implantable, non-pyrogenic and sterilized with ethylene oxide and CO2 mixture. The distal portion has a hydrophilic coating and consists of two lumens: one for balloon inflation and deflation, the other for guidewire advancement and retraction. The product is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Turkish citizen, * ≥18 years of age, * Has indication for percutaneous transluminal coronary angioplasty (PTCA), * Has indication to treat obstructive lesions of a native coronary artery or aortocoronary bypass or needs post dilatation of coronary stent * Fluydo NC using in the primary lesion treated during the procedure by the decision physician, * Has signed and dated the informed consent. Exclusion Criteria: * Has a previous diagnosis of coronary artery spasm in the absence of a significant stenosis. * Needs the device use in an unprotected left main coronary artery * Device use has not consistent with Instructions for Use. * Participating in another medical device or pharmaceutical clinical trial.

Locations (1)

Alvimedica

Istanbul, Turkey (Türkiye)