The FLUYDO NC Post Market Clinical Follow-up Study

Alvimedica

Status: Completed

Conditions: Coronary Artery Disease; Vascular Diseases; Coronary Disease

Treatments: Device: FLUYDO NC percutaneous transluminal coronary angioplasty balloon catheter

Study type: Observational

Funder types: Industry

Identifiers

NCT05965037

C32103

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.