Clinical trial NCT02752802: DyeVert System RCT
Official title: Single Site Randomized Control Trial Evaluating the DyeVert System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Angiography
Keywords: Contrast Media
Angiography
Lead sponsor: Osprey Medical, Inc
Sponsor class: INDUSTRY
First posted: 2016-04-27
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluate the Total Volume of CM Used Comparing the DyeVert Group to the Control Group.
timeFrame: All data will be collected on the day of the procedure, over an average of 12 hours.
Secondary outcomes:
measure: Assessment of the Quality of Angiographic Images Between Groups
timeFrame: AlAll data will be collected on the day of the procedure, over an average of 12 hours.
measure: Assessment of Incidence of Serious Adverse Device Effect for Subjects Treated With the DyeVert System During the Procedure.
timeFrame: All data will be collected on the day of the procedure, over an average of 12 hours.
Other outcomes:
Locations:
city: Lübeck
country: Germany
facility: University Hospital of Schleswig-Holstein
Study officials:
affiliation: University Hospital of Schleswig-Holstein, Lubeck
name: Steffen Desch, MD
role: PRINCIPAL_INVESTIGATOR
References:
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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. doi: 10.1016/s0735-1097(00)00917-7.
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. No abstract available.
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.
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.