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DyeVert Pilot Trial

NCT ID: NCT02606734

Last Updated: 2016-10-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2015-12-31

Brief Summary

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The purpose of this study is to evaluate the usability characteristics of DyeVert™ during normal clinical use and to understand the amount of contrast media (CM) diverted from the subject and saved over a total angiographic procedure.

Detailed Description

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Conditions

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Coronary Angiography

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment Arm

All subjects enrolled in the trial will use the DyeVert System.

Group Type OTHER

Coronary Angiography

Intervention Type DEVICE

The DyeVert System will be used during coronary angiographic procedures which include: diagnostic only, diagnostic + PCI or PCI only cases.

Interventions

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Coronary Angiography

The DyeVert System will be used during coronary angiographic procedures which include: diagnostic only, diagnostic + PCI or PCI only cases.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. The subject is indicated for a coronary angiogram or percutaneous coronary procedure
2. The subject is ≥ 18 years of age
3. The subject (or subject's legal representative) is willing and able to provide appropriate informed consent.

Exclusion Criteria

1. Subject is undergoing a STEMI procedure
2. The subject is female and currently pregnant
3. In the investigator's opinion, the subject is not considered to be a suitable candidate
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Osprey Medical, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Monash Health

Clayton, Victoria, Australia

Site Status

University Hospital of Schleswig-Holstein

Lübeck, , Germany

Site Status

Countries

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Australia Germany

Other Identifiers

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TP-6463

Identifier Type: -

Identifier Source: org_study_id