The purpose of this clinical study is to provide confirmation of the clinical safety and performance of the CINCOR* System in patients at risk of developing CIN who are undergoing interventional percutaneous coronary procedures.Further, the data…
ID
Source
Brief title
Condition
- Coronary artery disorders
- Nephropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety :
* To describe the safety of the CINCOR* System by analysing all system related
adverse events and calculating the serious system related event-free rate at 30
days post-procedure.
Performance:
* Rate of successful coronary sinus cannulation
* Time required for coronary sinus cannulation
* Volume of contrast agent used to place the Removal Catheter
* Diameter of the coronary sinus based on fluoroscopy images
* Total fluoroscopy time
* Total volume of blood collected during removal episodes
Secondary outcome
To estimate the rate of CIN in treated patients compared to historical controls.
To summarize the change in serum creatinine and estimated glomerular filtration
(eGFR) pre-procedure to 1 day and 4 days post-procedure.
Evaluate the percent of contrast media removal as a sub-study in selected
centers
To describe the safety of the CINCOR* System by summarizing all system related
adverse events and estimating the serious system related event-free rate
through 30 days post-procedure.
To estimate the rate of all Adverse Events (AE).
To estimate the rate of the following AEs:
Blood loss/bleeding meeting one of the following conditions:
Requires transfusion of * 2 units
Meets the definition for Thrombolysis in Myocardial Infarction (TIMI) Major or
Minor Bleeding
Coronary sinus perforation, dissection, or occlusion that requires treatment or
results in MI or death
Pericardial effusions (including pericardial tamponade) requiring treatment
Death
Myocardial infarction
Arrhythmias
Other events related to partial coronary sinus occlusion and suction
Background summary
Chronic kidney disease (CKD) is a growing health concern in the United States
and other western nations. The use of iodinated contrast agents has been
strongly associated with the acute reduction in kidney function, a condition
known as contrast-induced nephropathy (CIN).
Several strategies for preventing CIN have been evaluated. The basic
strategies include: (1) choice and quantity of CM; (2) peri-procedural
hydration; (3) end-organ protection; and (4) device based therapy. few
effective prophylactic or therapeutic interventions have conclusively
demonstrated evidence for reduction of CIN*. In fact, many patients at risk for
CIN may not undergo diagnostic procedures because the risks outweigh the
treatment benefits.
The advantage of the Osprey Medical CINCOR* System investigational device is in
achieving contrast retrieval sooner, prior to reaching the systemic circulation
and the kidneys thereby helping to avoid the development of CIN.
Study objective
The purpose of this clinical study is to provide confirmation of the clinical
safety and performance of the CINCOR* System in patients at risk of developing
CIN who are undergoing interventional percutaneous coronary procedures.
Further, the data from this trial will be used to develop hypotheses for a
randomized controlled trial to assess the effectiveness of the CINCOR* System
in preventing CIN in indicated patients.
Study design
The CINCOR* Trial will be conducted at up to 12 investigational centers in
Europe, Australia, and New Zealand. Up to 100 subjects will be enrolled. The
estimated time to complete enrollment is 12 months.
Intervention
A specially designed balloon catheter is percutaneously inserted into the
jugular or femoral vein and positioning inside the coronary sinus to remove
contrast media from the cardiac circulation in patients undergoing coronary
angiography procedures.
When X-ray dye is injected, the CINCOR* System will be activated for 8-12
seconds to collect a small amount of blood (about 1-1.5 tablespoons or 20-30mL)
that contains the x-ray dye. This will be repeated for each x-ray picture. It
is anticipated that no more that 500mL of blood will be collected in this way.
Study burden and risks
It is anticipated that subjects participating in the study will be exposed to
procedure and post-procedure risks similar to other interventional percutaneous
coronary procedures involving subjects with normal or impaired renal function.
Possible risks associated with the investigational device may include but are
not limited to:
* Allergic reaction to investigational device (nickel, titanium)
* Anemia
* Aneurysm, pseudoaneurysm, arteriovenous fistula
* Bleeding / re-bleeding
* Cardiac damage / perforation / tamponade
* Coronary Sinus Damage (perforation or rupture)
* Death
* Device failure
* Ecchymosis
* Embolism
* Fainting
* Fever, elevated temperature
* Heart rhythm disturbance
* Hematoma
* Hemorrhage
* Infection
* Myocardial infarction
* Open-heart surgery
* Pain
* Pulmonary embolism
* Renal failure requiring dialysis
* Stroke
* Transfusion
* Vessel trauma including a tear, unresolved dissection (separation of tissue
layers), or perforation (hole)
Participation in this trial will involve exposure to an additional small amount
of radiation above and beyond normal clinical management. This arises from the
X-rays used to aid in the placement of the special catheter in the heart. As
part of everyday living, everyone is exposed to naturally occurring background
radiation and receives a dose of about 2 millisievert (mSv) each year. The
additional effective dose the patient will receive from entering this trial is
approximately 0.3 mSv. At this dose level, no harmful effects of radiation
have been demonstrated as any effect is too small to measure.
Every effort will be made to minimize these risks and any discomfort.
Patients that are pregnant or currently breast feeding, may not participate in
this study.
The Osprey Medical CINCOR* System was subjected to a rigorous risk analysis as
part of the design process. Based on the risk analysis, complete in vitro and
in vivo testing was performed to demonstrate safety. The testing conducted on
the Osprey Medical Contrast Removal System was designed to comply with the
requirements of United States Food and Drug Administration (FDA) and EN ISO
14155 as well as other recognized national standards. The preclinical studies
have demonstrated that the potential risks have been addressed as far as
possible and that the device is as safe as feasibly possible prior to use in
humans as part of this clinical study.
The investigational plan is specifically designed to minimize risks through
careful subject selection, thorough training of investigator and adherence to
the schedule of post-operative follow-up subject visits and regular clinical
monitoring visits by designated monitoring personnel.
121 5th Avenue NW |
St. Paul MN 55112
USA
121 5th Avenue NW |
St. Paul MN 55112
USA
Listed location countries
Age
Inclusion criteria
1. The subject is at least 21 years of age.
2. The subject is a candidate for a therapeutic coronary PCI procedure of the left coronary artery (left main, left anterior descending coronary artery and/or left circumflex artery or branches of these vessels) anticipated to utilize at least 50 mL of iodinated contrast media (on the basis of a prior angiogram or pending angiographic confirmation).
3. The subject has documented CKD and an estimated eGFR > 20 and * 40 mL/min/1.73 m2 (as determined by the MDRD equation) ; or
an eGFR> 40 and < 60 mL/min/1.73 m2 and one or more of the following co-morbidities: stage III/IV congestive heart failure (as defined by NYHA criteria), diabetes mellitus, or 75 years of age or greater.
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 is currently undergoing renal dialysis.
2. The subject is in acute renal failure or has unstable renal function based on clinical findings and/or a known change in serum creatinine of * 0.5mg/dL or * 25% within 7 days prior to enrollment compared to the last serum creatinine measurement on record. If the serum creatinine has risen to this degree, then at least 2 serum creatinine measures drawn >48 hours but <7 days all within 0.5mg/dL must be present for a new baseline to be established.
3. The subject has received contrast media within 7 days prior to the procedure day or a second imaging study of any type which will require iodinated contrast is planned within the 30 days following the protocol-defined procedure.
4. The subject is expected to undergo any of the following: ventriculography, aortography, renal angiography, or any other injection of >10 cc of contrast in total other than coronary angiography or PCI as described below.
5. The subject has a known allergy to iodine-based contrast agents that cannot be adequately pre-medicated (patients with a history of true anaphylaxis may not be enrolled).
6. 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.
7. The subject 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 bleeding gross genitourinary bleeding).
8. The subject is currently on intravenous heparin that cannot be discontinued at least 4 hours before the procedure, intravenous bivalirudin that cannot be discontinued at least 4 hours before the procedure, intravenous abciximab that cannot be discontinued at least 24 hours before the procedure, intravenous tirofiban or eptifibatide that cannot be discontinued at least 6 hours before the procedure, or has received any low molecular weight heparin within 12 hours or factor Xa antagonist (including fondaparinux) within 24 hours.
9. 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.
10. The subject is hypotensive (systolic blood pressure < 90 mmHg not corrected by intravenous saline) or requiring intravenous pressors and/or intra-aortic balloon counterpulsation.
11. The subject has decompensated heart failure requiring intravenous diuretic, inotropic, vasopressor or intraaortic balloon support in the previous 7 days.
12. The subject has had recent (within last 72 hours) acute myocardial infarction as defined in the *Universal Definition of Myocardial Infarction*:
a. Detection of rise and/or fall of cardiac biomarkers (preferably troponin) with at least one value above the 99th percentile of the upper reference limit and at least one of the following
i. Symptoms of ischemia
ii. ECG changes indicative of new ischemia (new ST-T changes or new left bundle branch block)
iii. Development of pathological Q waves in the ECG
iv. Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality
13. The subject has undergone previous procedures involving both internal jugular vein(s) within last 8 weeks.
14. The subject requires an intra aortic balloon pump.
15. The subject has an International Normalized Ratio (INR) > 1.6 pre-procedure.
16. The subject has an active infection within the last month.
17. The subject has hemoglobin (Hb) < 10.0 g/dL within one (1) week of the procedure.
18. 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).
19. The subject has a life expectancy of less than twelve (12) months.
20. The subject has a pacemaker lead, percutaneous mitral annuloplasty or other device placed within the coronary sinus.
21. The subject has an unstable clinical situation precluding placement or operation of the Osprey Medical CINCOR* System.
22. The subject is currently participating in another investigational device or drug study that has not completed its primary endpoint.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL33663.101.10 |