Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
100 participants
OBSERVATIONAL
2022-11-01
2023-06-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Interventions
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FLUYDO NC percutaneous transluminal coronary angioplasty balloon catheter
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
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Inclusion Criteria
* ≥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
* 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.
18 Years
ALL
No
Sponsors
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CID S.p.A.
INDUSTRY
Alvimedica
INDUSTRY
Responsible Party
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Locations
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Alvimedica
Istanbul, , Turkey (Türkiye)
Countries
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Other Identifiers
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C32103
Identifier Type: -
Identifier Source: org_study_id
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