The FLUYDO NC Post Market Clinical Follow-up Study

NCT05965037 | Completed

• 1 other identifier: C32103
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Coronary Disease; Vascular Diseases

Outcome Measures

Primary Outcomes (5)

• Device success

  immediately after interventional procedure

• Successful inflation, achievement of appropriate diameter, and deflation of the balloon

  immediately after interventional procedure

• Decrease in the percent stenosis after balloon procedure

  immediately after interventional procedure

• No perforation, flow-limiting dissection or reduction in Thrombolysis in Myocardial Infarction (TIMI) flow grade

  immediately after interventional procedure

• No life-threatening arrhythmias (sustained ventricular tachycardia, ventricular fibrillation)

  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))

  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.

  discharge or 48 hours after index procedure, whichever happens first

Interventions

FLUYDO NC percutaneous transluminal coronary angioplasty balloon catheter DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alvimedica: lead
• CID S.p.A.: collaborator

Study Sites (1)

Alvimedica

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Disease; Vascular Diseases

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: July 28, 2023
• Study Start: November 1, 2022
• Primary Completion: June 15, 2023
• Study Completion: June 15, 2023
• Last Updated: May 13, 2024

Record last verified: 2024-05

Locations

TU (1)