The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The FLUYDO NC Post Market Clinical Follow-up Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05965037
Recruitment Status : Completed
First Posted : July 28, 2023
Last Update Posted : May 13, 2024
Sponsor:
Collaborator:
CID S.p.A.
Information provided by (Responsible Party):
Alvimedica

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment
Coronary Artery Disease Coronary Disease Vascular Diseases Device: FLUYDO NC percutaneous transluminal coronary angioplasty balloon catheter

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Multicenter Prospective Registry in Current Clinical Practice With the Non-compliant Coronary Angioplasty Balloon Catheter. The FLUYDO NC Post Market Clinical Follow-up Study
Actual Study Start Date : November 1, 2022
Actual Primary Completion Date : June 15, 2023
Actual Study Completion Date : June 15, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • 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.

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05965037


Locations
Layout table for location information
Turkey
Alvimedica
Istanbul, Turkey
Sponsors and Collaborators
Alvimedica
CID S.p.A.
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Alvimedica
ClinicalTrials.gov Identifier: NCT05965037    
Other Study ID Numbers: C32103
First Posted: July 28, 2023    Key Record Dates
Last Update Posted: May 13, 2024
Last Verified: May 2024

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronary Artery Disease
Coronary Disease
Vascular Diseases
Myocardial Ischemia
 Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases