DyeVert System RCT

January 9, 2017 updated by: Osprey Medical, Inc

Single Site Randomized Control Trial Evaluating the DyeVert System

The purpose of this study is to evaluate the amount of contrast media (CM) saved using the DyeVert system in diagnostic angiographic procedures compared to a control group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, randomized, parallel group, single center clinical evaluation of the DyeVert System. Subjects undergoing a diagnostic coronary angiogram procedure with a 5 French catheter are eligible to participate in this study. The treatment group will use the DyeVert System.

The trial will be conducted at one center, located in Germany. A sample size of 96 evaluable subjects will provide a sufficient number of samples to evaluate the primary objectives.

Randomization will occur following confirmation that the subject meets the inclusion/exclusion criteria and has signed an informed consent. Subjects that are anticipated to be a diagnostic only procedure, but end up being an ad-hoc PCI, can still remain enrolled in the trial. If a subject proceeds to a PCI, data will only be collected through the diagnostic portion of the case.

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Lübeck, Germany, 23538
        • University Hospital of Schleswig-Holstein

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. The subject is indicated for a diagnostic coronary angiogram procedure with a 5 French catheter only.
  2. The subject is ≥ 18 years of age
  3. The subject is willing and able to provide appropriate informed consent.

Exclusion Criteria:

  1. Subject is undergoing a STEMI procedure
  2. Subject has previously been diagnosed with anomalous coronary anatomy
  3. Subject has previously underwent coronary artery bypass grafting
  4. Subject has severe peripheral artery disease at access site
  5. Subject is having a staged PCI
  6. The subject is female and currently pregnant
  7. In the investigator's opinion, the subject is not considered to be a suitable candidate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treatment
The treatment group will include standard of care for diagnostic angiogram along with the utilizization of the DyeVert system.
Device: Diagnostic Coronary Angiogram
Diagnostic angiographic procedure with the use of the DyeVert System.
Active Comparator: Control
The control group will include standard of care for diagnostic coronary angiograms.
Device: Diagnostic Coronary Angiogram
Diagnostic angiographic procedure with the use of the DyeVert System.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the Total Volume of CM Used Comparing the DyeVert Group to the Control Group.
Time Frame: All data will be collected on the day of the procedure, over an average of 12 hours.
DyeVert is intended to reduce the total amount of contrast media (CM) administered during procedures requiring the injection of contrast media. Clinical evidence has demonstrated that CM can be toxic to the kidneys, leading to contrast induced nephropathy (CIN)
All data will be collected on the day of the procedure, over an average of 12 hours.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the Quality of Angiographic Images Between Groups
Time Frame: AlAll data will be collected on the day of the procedure, over an average of 12 hours.
To assess the adequacy of the image quality. The proportion of images in which contrast opacification is deemed sufficient to evaluate the desired anatomical structures adequately will be compared between the DyeVert and control groups.
AlAll data will be collected on the day of the procedure, over an average of 12 hours.
Assessment of Incidence of Serious Adverse Device Effect for Subjects Treated With the DyeVert System During the Procedure.
Time Frame: All data will be collected on the day of the procedure, over an average of 12 hours.
To assess the incidence of Serious Adverse Device Effect for subjects treated with the DyeVert System during the procedure for treatment subjects only.
All data will be collected on the day of the procedure, over an average of 12 hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Osprey Medical, Inc

Investigators

  • Principal Investigator: Steffen Desch, MD, University Hospital of Schleswig-Holstein, Lubeck

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

April 22, 2016

First Submitted That Met QC Criteria

April 22, 2016

First Posted (Estimate)

April 27, 2016

Study Record Updates

Last Update Posted (Actual)

February 28, 2017

Last Update Submitted That Met QC Criteria

January 9, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TP-6495

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronary Angiography

Clinical Trials on Diagnostic Coronary Angiogram

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gabon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe