NCT02578173

Brief Summary

Purpose: To evaluate the accuracy of the AVERT PLUS to monitor contrast volume used during angiographic procedures. This will be a first in man prospective observational study of the accuracy of this system to quantify contrast volume used during clinically indicated angiography in the cardiac catheterization laboratory.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2015

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

October 10, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 16, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

June 21, 2016

Status Verified

June 1, 2016

Enrollment Period

5 months

First QC Date

October 10, 2015

Last Update Submit

June 19, 2016

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

  • Observational study of the accuracy of the AVERT PLUS CM system to quantify contrast volume during a clinically indicated procedure.

    The fluid volume of contrast media used during the angiography procedure will be measured in milliliters.

    The total volume of contrast received by the subject will be measured at the conclusion of the angiography procedure, procedure duration from 30 minutes to 4 hours dependent on patient's clinical status; no further measurements thereafter.

Study Arms (2)

AVERT PLUS

The AVERT PLUS will be used on the first 10 patients enrolled in the study. The AVERT PLUS is a contrast monitoring system which is used to precisely measure the volume of contrast delivered to the patient.

Device: AVERT PLUS

Non device group

The second group of 10 patients will undergo the scheduled angiography using the standard method of measuring contrast dye delivery.

Interventions

AVERT PLUSDEVICE
AVERT PLUS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with cardiovascular disease who are undergoing clinically indicated coronary or peripheral angiography

You may qualify if:

  • Patients undergoing clinically indicated coronary or peripheral angiography

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Michele Shepard

    Osprey Medical, Inc

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

October 10, 2015

First Posted

October 16, 2015

Study Start

October 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

June 21, 2016

Record last verified: 2016-06