The Alvision™ Interventional Cardiology Diagnostic Catheter Post Market Clinical Follow-up (PMCF) Study.
NCT ID: NCT05908422
Last Updated: 2024-05-20
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
2023-01-01
2023-05-15
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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Alvision™ Interventional Cardiology Diagnostic Catheter
The Alvision™ Interventional Cardiology Diagnostic Catheter is a single use only, thin, flexible single lumen tube, with a proximal hub, sterilized with ethylene oxide (EO) gas, non-pyrogenic. The product is defined as a catheter to inject a contrast medium into selected blood vessels.
Eligibility Criteria
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Inclusion Criteria
* ≥18 years of age,
* Has indication for a diagnostic coronarography according to Alvision™ Instruction for use,
* Has signed and dated the informed consent.
Exclusion Criteria
* Has synthetic vascular grafts through which the Alvision™ Interventional Cardiology Diagnostic Catheter should pass
* Participating in another medical device or pharmaceutical clinical trial
18 Years
ALL
No
Sponsors
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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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C42102
Identifier Type: -
Identifier Source: org_study_id
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