Coronary Artery DiseaseNCT05965037
The FLUYDO NC Post Market Clinical Follow-up Study
An observational study of Coronary Artery Disease and Coronary Disease, run by Alvimedica at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Disease, Vascular Diseases
- What is being tested?
- FLUYDO NC percutaneous transluminal coronary angioplasty balloon catheter
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2022to 15 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients meeting the patient selection criteria, over 18 years old, eligible for a catheter with FLUYDO NC catheter.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Coronary Artery Disease, Coronary Disease, Vascular Diseases
- Being tested
- FLUYDO NC percutaneous transluminal coronary angioplasty balloon catheter
- Medical subject headings
- Coronary Artery Disease, Coronary Disease, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Device success
Measured: immediately after interventional procedure
Successful inflation, achievement of appropriate diameter, and deflation of the balloon
Measured: immediately after interventional procedure
Decrease in the percent stenosis after balloon procedure
Measured: immediately after interventional procedure
No perforation, flow-limiting dissection or reduction in Thrombolysis in Myocardial Infarction (TIMI) flow grade
Measured: immediately after interventional procedure
No life-threatening arrhythmias (sustained ventricular tachycardia, ventricular fibrillation)
Measured: immediately after interventional procedure
Secondary outcomes (2)
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))
Measured: 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.
Measured: discharge or 48 hours after index procedure, whichever happens first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start1 Nov 2022
- Primary completion15 Jun 2023
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alvimedica
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CID S.p.A.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05965037
- Sponsor's protocol ID
- C32103
- Status last verified
- May 2024
- First submitted
- 30 May 2023
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05965037
- Acronym / sponsor ID
- C32103
- Conditions
- Coronary Artery Disease, Coronary Disease, Vascular Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- AlvimedicaIndustry (pharma, biotech, devices)
- Collaborators
- CID S.p.A.
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 28 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients meeting the patient selection criteria, over 18 years old, eligible for a catheter with FLUYDO NC catheter.
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FLUYDO NC percutaneous transluminal coronary angioplasty balloon catheterThe 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. | Device | – |
Primary outcome
Device success
Time frame: immediately after interventional procedure
Successful inflation, achievement of appropriate diameter, and deflation of the balloon
Time frame: immediately after interventional procedure
Decrease in the percent stenosis after balloon procedure
Time frame: 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
No life-threatening arrhythmias (sustained ventricular tachycardia, ventricular fibrillation)
Time frame: immediately after interventional procedure
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Coronary Disease, run by Alvimedica at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device success (time frame: immediately after interventional procedure). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2024.