The FLUYDO NC Post Market Clinical Follow-up Study

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05965037
• Other study ID #: C32103
• Status: Completed
• Start date: November 1, 2022
• Est. completion date: June 15, 2023

Study information

• Verified date: May 2024
• Source: Alvimedica
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 15, 2023
• Est. primary completion date: June 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Vascular Diseases

Intervention

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.

Locations

Country	Name	City	State
Turkey	Alvimedica	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Alvimedica	CID S.p.A.

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device success		immediately after interventional procedure
Primary	Successful inflation, achievement of appropriate diameter, and deflation of the balloon		immediately after interventional procedure
Primary	Decrease in the percent stenosis after balloon procedure		immediately after interventional procedure
Primary	No perforation, flow-limiting dissection or reduction in Thrombolysis in Myocardial Infarction (TIMI) flow grade		immediately after interventional procedure
Primary	No life-threatening arrhythmias (sustained ventricular tachycardia, ventricular fibrillation)		immediately after interventional procedure
Secondary	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))		Discharge or 48 hours after index procedure, whichever happens first
Secondary	Rate of Target Lesion Failure (TLF) Measurement: Percentage of a composite of cardiac death, target vessel myocardial infarction (TV-MI), and CI-TLR.		discharge or 48 hours after index procedure, whichever happens first