DyeVert Pilot Trial

Osprey Medical

Status: Completed

Conditions: Coronary Angiography

Treatments: Device: Coronary Angiography

Study type: Interventional

Funder types: Industry

Identifiers

NCT02606734

TP-6463

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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44 participants in 1 patient group

Treatment Arm

Other group

Description:

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

Treatment:

Device: Coronary Angiography