DyeVert System RCT

Coronary Angiography Clinical Trial

Official title:

Single Site Randomized Control Trial Evaluating the DyeVert System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02752802
• Other study ID #: TP-6495
• Status: Completed
• Phase: N/A
• First received: April 22, 2016
• Last updated: July 5, 2016
• Start date: April 2016
• Est. completion date: May 2016

Study information

• Verified date: July 2016
• Source: Osprey Medical, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Coronary Angiography

Intervention

Device:
• Diagnostic Coronary Angiogram
Diagnostic angiographic procedure with the use of the DyeVert System.

Locations

Country	Name	City	State
Germany	University Hospital of Schleswig-Holstein	Lübeck

Sponsors (1)

Lead Sponsor	Collaborator
Osprey Medical, Inc

Country where clinical trial is conducted

Germany, 

References & 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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the total volume (percentage) 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.	No
Secondary	Assessment of the quality of angiographic images between groups	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.	All data will be collected on the day of the procedure	No
Secondary	Assessment of incidence of Serious Adverse Device Effect for subjects treated with the DyeVert System during the procedure.	To assess the incidence of Serious Adverse Device Effect for subjects treated with the DyeVert System during the procedure. Descriptive statistics of frequency and the associated 95% confidence intervals will be used for this endpoint; no formal hypothesis test will be performed.	All data will be collected on the day of the procedure	No