MedTrace Logo

The FLUYDO NC Post Market Clinical Follow-up Study

NCT05965037 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2024-05-13

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

FLUYDO NC percutaneous transluminal coronary angioplasty balloon catheter

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.

Sponsors & Collaborators

  • CID S.p.A.

    collaborator INDUSTRY

  • Alvimedica

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2023-06-15
Completion
2023-06-15

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05965037 on ClinicalTrials.gov