Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Active Comparator | The treatment group will include standard of care for diagnostic angiogram along with the utilizization of the DyeVert system. |
|
| Control | Active Comparator | The control group will include standard of care for diagnostic coronary angiograms. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diagnostic Coronary Angiogram | Device | Diagnostic angiographic procedure with the use of the DyeVert System. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | AlAll data will be collected on the day of the procedure, over an average of 12 hours. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Steffen Desch, MD | University Hospital of Schleswig-Holstein, Lubeck | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Schleswig-Holstein | Lübeck | 23538 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25074372 | Background | 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. | |
| 11079656 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | The treatment group will include standard of care for diagnostic angiogram along with the utilizization of the DyeVert system. Diagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System. |
| FG001 | Control | The control group will include standard of care for diagnostic coronary angiograms. Diagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | The treatment group will include standard of care for diagnostic angiogram along with the utilizization of the DyeVert system. Diagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System. |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Posted | Mean | Standard Deviation | ml | All data will be collected on the day of the procedure, over an average of 12 hours. |
|
At point of discharge from index procedure, approximetly 12 hours.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment | The treatment group will include standard of care for diagnostic angiogram along with the utilizization of the DyeVert system. Diagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Extended Hospital Stay | General disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| General Adverse Events | General disorders |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michele Shepard, Vice President of Clinical Affairs | Osprey Medical, Inc | 952-955-8236 | mshepard@ospreymed.com |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 for treatment subjects only. | All data will be collected on the day of the procedure, over an average of 12 hours. |
| 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. |
| 19830793 | 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. |
| 23394215 | 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. |
| 8622223 | 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. |
The control group will include standard of care for diagnostic coronary angiograms. Diagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Gender | Count of Participants | Participants |
|
The control group will include standard of care for diagnostic coronary angiograms.
Diagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System.
|
|
| 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. | Posted | Count of Units | Images | AlAll data will be collected on the day of the procedure, over an average of 12 hours. | Images | Images |
|
|
|
| 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 for treatment subjects only. | Only treatments subjects were analyzed for this endpoint. | Posted | Number | Number of Events | All data will be collected on the day of the procedure, over an average of 12 hours. |
|
|
|
| 2 |
| 48 |
| 2 |
| 48 |
| EG001 | Control | The control group will include standard of care for diagnostic coronary angiograms. Diagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System. | 4 | 48 | 3 | 48 |
| Death | General disorders |
|
Not provided
Not provided