The FLUYDO NC Post Market Clinical Follow-up Study

May 10, 2024 updated by: Alvimedica

Multicenter Prospective Registry in Current Clinical Practice With the Non-compliant Coronary Angioplasty Balloon Catheter. The FLUYDO NC Post Market Clinical Follow-up Study

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Alvimedica

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients meeting the patient selection criteria, over 18 years old, eligible for a catheter with FLUYDO NC catheter.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Device success
Time Frame: immediately after interventional procedure
immediately after interventional procedure
Successful inflation, achievement of appropriate diameter, and deflation of the balloon
Time Frame: immediately after interventional procedure
immediately after interventional procedure
Decrease in the percent stenosis after balloon procedure
Time Frame: immediately after interventional procedure
immediately after interventional procedure
No perforation, flow-limiting dissection or reduction in Thrombolysis in Myocardial Infarction (TIMI) flow grade
Time Frame: immediately after interventional procedure
immediately after interventional procedure
No life-threatening arrhythmias (sustained ventricular tachycardia, ventricular fibrillation)
Time Frame: immediately after interventional procedure
immediately after interventional procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
Procedural success: Measurement: Percentage of device success without major adverse cardiovascular events (MACE) (composite of all death, myocardial infarction (MI), and clinically indicated target lesion revascularization (CI-TLR))
Time Frame: Discharge or 48 hours after index procedure, whichever happens first
Discharge or 48 hours after index procedure, whichever happens first
Rate of Target Lesion Failure (TLF) Measurement: Percentage of a composite of cardiac death, target vessel myocardial infarction (TV-MI), and CI-TLR.
Time Frame: discharge or 48 hours after index procedure, whichever happens first
discharge or 48 hours after index procedure, whichever happens first

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alvimedica

Collaborators

CID S.p.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Actual)

June 15, 2023

Study Completion (Actual)

June 15, 2023

Study Registration Dates

First Submitted

May 30, 2023

First Submitted That Met QC Criteria

July 19, 2023

First Posted (Actual)

July 28, 2023

Study Record Updates

Last Update Posted (Actual)

May 13, 2024

Last Update Submitted That Met QC Criteria

May 10, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C32103

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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