The Alvision™ Interventional Cardiology Diagnostic Catheter Post Market Clinical Follow-up (PMCF) Study.

NCT ID: NCT05908422

Last Updated: 2024-05-20

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2023-05-15

Brief Summary

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The objective of this prospective observational study is to collect clinical data on the medical device Alvision™ Interventional Cardiology Diagnostic Catheter in an unselected population in the current clinical practice

Detailed Description

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Within the scope of this observational medical device trial, brand/model of the catheter that will be used during the PCI will be decided by the physician and decision of the physician won't be interfered. PCI will be performed according to the standard clinical procedures. Data of the patients to whom Alvision™ Interventional Cardiology Diagnostic Catheter is applied will be gathered for the purpose of this study.

Conditions

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Coronary Artery Disease Coronary Disease Vascular Diseases

Study Design

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Observational Model Type

OTHER

Study Time Perspective

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Turkish citizen,
* ≥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

* Having a known allergic reaction to any of the composition of Alvision™ Interventional Cardiology Diagnostic Catheter.
* Has synthetic vascular grafts through which the Alvision™ Interventional Cardiology Diagnostic Catheter should pass
* Participating in another medical device or pharmaceutical clinical trial
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alvimedica

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Alvimedica

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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C42102

Identifier Type: -

Identifier Source: org_study_id

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