Radiographic Contrast Agent Nephropathy
Conditions
Keywords
Acute Kidney Injury, Iodinated Contrast Agent Retrieval, Coronary Sinus Cannulation
Brief summary
The purpose of this clinical trial is to demonstrate the efficacy and safety of the Osprey Medical CINCOR™ Contrast Removal System.
Detailed description
The CINCOR™ Catheter System to retrieve contrast media from the coronary sinus following injection during percutaneous coronary interventions.
Interventions
DEVICECINCOR™ System and contrast conservation unit (CCS-1)
Catheter based system to reduce and remove contrast media and contrast modulator to reduce contrast media
OTHERStandard of Care plus peri-procedural hydration
The control group will receive a peri and post-procedural hydration rate.
Sponsors
Osprey Medical, Inc
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The subject is at least 18 years of age. 2. The subject is a candidate for a therapeutic coronary PCI procedure of the left coronary artery and/or its branches or a combination procedure including left coronary artery/branches AND right coronary artery that is expected to utilize at least 50 mL of iodinated contrast media. 3. The subject has baseline eGFR between 20 and 30 mL/min/1.73 m2 inclusive (as determined by the MDRD equation (Levey 1993)); or patient has eGFR above 30 but less than or equal to 60 with at least two of the following: stage III/IV NYHA congestive heart failure, diabetes mellitus, hypertension, age of at least 75 years. 4. The subject (or subject's legal representative) is willing and able to provide appropriate informed consent. 5. The subject is willing and able to comply with the requirements of the study protocol, including the predefined follow-up evaluations.
Exclusion criteria
1. The subject has unstable renal function (acute renal failure or change in serum creatinine of \> 0.5mg/dL or \> 25% within 7 days of the procedure not attributed to hydration therapy). 2. The subject requires dialysis. 3. The subject has received contrast media within 7 days of the procedure. 4. The subject will receive \> 10 ml of iodinated contrast media in any location other than the coronary arteries (e.g. ventriculography, aortography, renal angiography) during the procedure or within a period of 30 days after the procedure. 5. The subject requires one or more of the following nephrotoxic agents: Aminoglycoside antibiotics, Sulfonamides, Amphotericin B, Levofloxacin, Ciprofloxacin, Rifampin, Tetracycline, Intravenous Acyclovir, Pentamidine, Penicillin and Cephalosporins, Cisplatin, Methotrexate, Mitomycin, Cyclosporine, Tacrolimus. 6. The subject has hemoglobin (Hb) \< 9.5 g/dL within one (1) week of the procedure. 7. The subject is hemodynamically unstable or requires hemodynamic support including intra-venous inotropes, vasopressors, or any type of ventricular assist devices (including intra-aortic balloon pumps, the Impella cardiac assist device, the TandemHeart VAD, and surgically implanted ventricular assist devices). 8. The subject has had acute myocardial infarction within last 24 hours (as defined in the Universal Definition of Myocardial Infarction (Thygesen 2007) or has biomarkers of cardiac injury that have not stabilized. (Patients with MI within 96 hours of index procedure must demonstrate falling biomarkers of cardiac injury). 9. The subject has any of the following procedural contra-indications 1. has a left heart pacing lead or other implant indwelling in the coronary sinus or has had an artificial valve or pacemaker lead implanted in the right heart within 8 weeks of the planned procedure 2. has a known bleeding diathesis (e.g. thrombocytopenia \[\<100,000 cells/mm3\], heparin-induced thrombocytopenia, hemophilia, or von Willebrand disease, any history of intracranial bleeding, or gastrointestinal or gross genitourinary bleeding) 3. The subject is currently on intravenous anti-coagulation that cannot be discontinued prior to the procedure 4. The subject has a known hypersensitivity to both heparin and bivalirudin or aspirin or all thienopyridine agents or iodinated contrast that cannot be adequately pre-medicated 5. The subject has an active systemic infection 6. The subject refuses to accept blood products (e.g. Jehovah's Witness) 10. The subject is known to be or suspected to be pregnant, or is lactating (all women of child-bearing potential must have a negative pregnancy test within 72 hours before participating in this protocol). 11. The subject is currently participating in another investigational device or drug study that has not reached its primary endpoint.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluating Local Events. | Through 30 days post-procedure. | Events evaluated include: * Coronary sinus perforation, dissection, or occlusion that requires treatment or results in MI or death * Pericardial effusions (including pericardial tamponade) requiring treatment |
| Incidence of Contrast Induced Nephropathy (CIN) in Subjects. | Through 72 hours post-procedure | CIN is defined as a post-procedure relative serum creatinine increase ≥ 25% or an absolute serum creatinine increase of ≥ 0.5 mg/dL). |
| Evaluating Bleeding/Transfusion Events. | Through 30 days post-procedure | Bleeding/transfusion events evaluated: * Blood loss requiring transfusion of ≥ 2 units * Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding * TIMI Minor Bleeding |
Secondary
| Measure | Time frame |
|---|---|
| Change in Kidney Function Between the Randomized Groups. | Up to 96 hours post-procedure |
Countries
Germany, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CINCOR™ System Treatment Use of the CINCOR™ System and CCS-1 device during the PCI procedure plus Standard of Care peri-procedural hydration for the prevention of CIN.
CINCOR™ System and CCS-1: Catheter based system to reduce and remove contrast media and contrast modulator to reduce contrast media
Peri-procedural hydration: The control group will receive a peri and post-procedural hydration rate. | 13 |
| Standard of Care Peri-procedural hydration with isotonic saline or sodium bicarbonate for at least 2 hours prior to the procedure and 6-12 hours post-procedure.
Peri-procedural hydration: The control group will receive a peri and post-procedural hydration rate. | 3 |
| Total | 16 |
Baseline characteristics
| Characteristic | CINCOR™ System Treatment | Standard of Care | Total |
|---|---|---|---|
| Age, Continuous | 67.2 years STANDARD_DEVIATION 11.5 | 82 years STANDARD_DEVIATION 13.8 | 71 years STANDARD_DEVIATION 11.1 |
| Sex: Female, Male Female | 3 Participants | 1 Participants | 4 Participants |
| Sex: Female, Male Male | 10 Participants | 2 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 13 | 0 / 3 |
| serious Total, serious adverse events | 2 / 13 | 0 / 3 |
Outcome results
Primary
Evaluating Bleeding/Transfusion Events.
Bleeding/transfusion events evaluated: * Blood loss requiring transfusion of ≥ 2 units * Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding * TIMI Minor Bleeding
Time frame: Through 30 days post-procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment (Roll In and Randomized) | Evaluating Bleeding/Transfusion Events. | 0 events |
| Control | Evaluating Bleeding/Transfusion Events. | 0 events |
Primary
Evaluating Local Events.
Events evaluated include: * Coronary sinus perforation, dissection, or occlusion that requires treatment or results in MI or death * Pericardial effusions (including pericardial tamponade) requiring treatment
Time frame: Through 30 days post-procedure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment (Roll In and Randomized) | Evaluating Local Events. | 0 events |
| Control | Evaluating Local Events. | 0 events |
Primary
Incidence of Contrast Induced Nephropathy (CIN) in Subjects.
CIN is defined as a post-procedure relative serum creatinine increase ≥ 25% or an absolute serum creatinine increase of ≥ 0.5 mg/dL).
Time frame: Through 72 hours post-procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment (Roll In and Randomized) | Incidence of Contrast Induced Nephropathy (CIN) in Subjects. | 2 participants |
| Control | Incidence of Contrast Induced Nephropathy (CIN) in Subjects. | 1 participants |
Secondary
Change in Kidney Function Between the Randomized Groups.
Time frame: Up to 96 hours post-procedure
Population: Change in eGFR was available for 2 treatment and 1 control subject. 1 out of range eGFR value for a subject (0.1) was not used as this value is not clinically feasible.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment (Roll In and Randomized) | Change in Kidney Function Between the Randomized Groups. | -6.33 mL/min/1.73m^2 | Standard Deviation 1.1 |
| Control | Change in Kidney Function Between the Randomized Groups. | -6.95 mL/min/1.73m^2 | Standard Deviation 3.61 |