Status:
COMPLETED
The FLUYDO NC Post Market Clinical Follow-up Study
Lead Sponsor:
Alvimedica
Collaborating Sponsors:
CID S.p.A.
Conditions:
Coronary Artery Disease
Coronary Disease
Eligibility:
All Genders
18+ years
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 15 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05965037
Start Date
November 1 2022
End Date
June 15 2023
Last Update
May 13 2024
Active Locations (1)
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1
Alvimedica
Istanbul, Turkey (Türkiye)