Clinical trial NCT05965037: The FLUYDO NC Post Market Clinical Follow-up 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Coronary Disease
Vascular Diseases
Lead sponsor: Alvimedica
Sponsor class: INDUSTRY
Collaborators: name: CID S.p.A.
First posted: 2023-07-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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.

Primary outcomes:
measure: Device success
timeFrame: immediately after interventional procedure
measure: Successful inflation, achievement of appropriate diameter, and deflation of the balloon
timeFrame: immediately after interventional procedure
measure: Decrease in the percent stenosis after balloon procedure
timeFrame: immediately after interventional procedure
measure: No perforation, flow-limiting dissection or reduction in Thrombolysis in Myocardial Infarction (TIMI) flow grade
timeFrame: immediately after interventional procedure
measure: No life-threatening arrhythmias (sustained ventricular tachycardia, ventricular fibrillation)
timeFrame: immediately after interventional procedure
Secondary outcomes:
measure: 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))
timeFrame: Discharge or 48 hours after index procedure, whichever happens first
measure: Rate of Target Lesion Failure (TLF) Measurement: Percentage of a composite of cardiac death, target vessel myocardial infarction (TV-MI), and CI-TLR.
timeFrame: discharge or 48 hours after index procedure, whichever happens first
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Alvimedica
Study officials:
References: