DyeVert System RCT

NCT02752802 | Completed Results

• 1 other identifier: TP-6495
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Angiography

Keywords

Contrast Media; Angiography

Outcome Measures

Primary Outcomes (1)

• Evaluate the Total Volume of CM Used Comparing the DyeVert Group to the Control Group.

  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 Outcomes (2)

• Assessment of the Quality of Angiographic Images Between 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.

  All data will be collected on the day of the procedure, over an average of 12 hours.

Study Arms (2)

Treatment

ACTIVE COMPARATOR

The treatment group will include standard of care for diagnostic angiogram along with the utilizization of the DyeVert system.

Device: Diagnostic Coronary Angiogram

Control

ACTIVE COMPARATOR

The control group will include standard of care for diagnostic coronary angiograms.

Device: Diagnostic Coronary Angiogram

Interventions

Diagnostic Coronary Angiogram DEVICE

Diagnostic angiographic procedure with the use of the DyeVert System.

Control; Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Osprey Medical, Inc: lead

Study Sites (1)

University Hospital of Schleswig-Holstein

Lübeck, 23538, Germany

Location

Related Publications (5)

• Brown JR, Solomon RJ, Sarnak MJ, McCullough PA, Splaine ME, Davies L, Ross CS, Dauerman HL, Stender JL, Conley SM, Robb JF, Chaisson K, Boss R, Lambert P, Goldberg DJ, Lucier D, Fedele FA, Kellett MA, Horton S, Phillips WJ, Downs C, Wiseman A, MacKenzie TA, Malenka DJ; Northern New England Cardiovascular Disease Study Group. Reducing contrast-induced acute kidney injury using a regional multicenter quality improvement intervention. Circ Cardiovasc Qual Outcomes. 2014 Sep;7(5):693-700. doi: 10.1161/CIRCOUTCOMES.114.000903. Epub 2014 Jul 29.

  PMID: 25074372 BACKGROUND

• Gruberg L, Mintz GS, Mehran R, Gangas G, Lansky AJ, Kent KM, Pichard AD, Satler LF, Leon MB. The prognostic implications of further renal function deterioration within 48 h of interventional coronary procedures in patients with pre-existent chronic renal insufficiency. J Am Coll Cardiol. 2000 Nov 1;36(5):1542-8. doi: 10.1016/s0735-1097(00)00917-7.

  PMID: 11079656 BACKGROUND

• Klein LW, Sheldon MW, Brinker J, Mixon TA, Skelding K, Strunk AO, Tommaso CL, Weiner B, Bailey SR, Uretsky B, Kern M, Laskey W; Interventional Committee of the Society for Cardiovascular Angiography and Interventions. The use of radiographic contrast media during PCI: a focused review: a position statement of the Society of Cardiovascular Angiography and Interventions. Catheter Cardiovasc Interv. 2009 Nov 1;74(5):728-46. doi: 10.1002/ccd.22113. No abstract available.

  PMID: 19830793 BACKGROUND

• Lameire N, Kellum JA; KDIGO AKI Guideline Work Group. Contrast-induced acute kidney injury and renal support for acute kidney injury: a KDIGO summary (Part 2). Crit Care. 2013 Feb 4;17(1):205. doi: 10.1186/cc11455.

  PMID: 23394215 BACKGROUND

• Levy EM, Viscoli CM, Horwitz RI. The effect of acute renal failure on mortality. A cohort analysis. JAMA. 1996 May 15;275(19):1489-94.

  PMID: 8622223 BACKGROUND

Results Point of Contact

• Title: Michele Shepard, Vice President of Clinical Affairs
• Organization: Osprey Medical, Inc

mshepard@ospreymed.com

952-955-8236

Study Officials

• Steffen Desch, MD

  University Hospital of Schleswig-Holstein, Lubeck

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2016
• First Posted: April 27, 2016
• Study Start: April 1, 2016
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: February 28, 2017
• Results First Posted: February 28, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)