The FLUYDO NC Post Market Clinical Follow-up Study

Completed

• Conditions: Coronary Artery Disease; Vascular Diseases; Coronary Disease

• Registration Number: NCT05965037
• Lead Sponsor: Alvimedica

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-01
• Study First Submitted: 2023-05-30
• Primary Completion: 2023-06-15
• Study Completion: 2023-06-15
• Study First Submitted QC: 2023-07-19
• Study First Posted: 2023-07-28
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-10
• Last Update Posted: 2024-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Device success	immediately after interventional procedure
No life-threatening arrhythmias (sustained ventricular tachycardia, ventricular fibrillation)	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

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Alvimedica; 🇹🇷 Istanbul, Turkey