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Completed

NCT Number: NCT05965037

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Alvimedica

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Alvimedica

Industry

Collaborators

  • CID S.p.A.

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 28, 2023
Registry last updated
May 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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