Contrast Media Reduction and Removal in Patients With Chronic Kidney Disease (CKD) (PRESERV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01168024
Recruitment Status : Terminated (Study closed by sponsor prior to completing enrollment goal.)
First Posted : July 22, 2010
Results First Posted : December 12, 2016
Last Update Posted : December 12, 2016
Information provided by (Responsible Party):
Osprey Medical, Inc

Brief Summary:
The purpose of this clinical trial is to demonstrate the efficacy and safety of the Osprey Medical CINCOR™ Contrast Removal System.

Condition or disease Intervention/treatment Phase
Radiographic Contrast Agent Nephropathy Device: CINCOR™ System and contrast conservation unit (CCS-1) Other: Standard of Care plus peri-procedural hydration Not Applicable

Detailed Description:
The CINCOR™ Catheter System to retrieve contrast media from the coronary sinus following injection during percutaneous coronary interventions.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: PRESERV (Prospective Randomized Evaluation to Study the Effects of Reduced Contrast Media on the Vitality of the Kidney) Pivotal Trial
Study Start Date : December 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: CINCOR™ System Treatment
Use of the CINCOR™ System and CCS-1 device during the pericutanous coronary intervention (PCI) procedure plus Standard of Care peri-procedural hydration for the prevention of contrast induced nephropathy (CIN).
Device: CINCOR™ System and contrast conservation unit (CCS-1)
Catheter based system to reduce and remove contrast media and contrast modulator to reduce contrast media

Other: Standard of Care plus peri-procedural hydration
The control group will receive a peri and post-procedural hydration rate.

Standard of Care
The control group will receive a peri and post-procedural hydration rate.
Other: Standard of Care plus peri-procedural hydration
The control group will receive a peri and post-procedural hydration rate.

Primary Outcome Measures :
  1. Incidence of Contrast Induced Nephropathy (CIN) in Subjects. [ Time Frame: 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).

  2. Evaluating Bleeding/Transfusion Events. [ Time Frame: 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

  3. Evaluating Local Events. [ Time Frame: 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

Secondary Outcome Measures :
  1. Change in Kidney Function Between the Randomized Groups. [ Time Frame: Up to 96 hours post-procedure ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01168024

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Sponsors and Collaborators
Osprey Medical, Inc
Principal Investigator: Gregg Stone, MD CRF

Responsible Party: Osprey Medical, Inc Identifier: NCT01168024     History of Changes
Other Study ID Numbers: TP-6142
First Posted: July 22, 2010    Key Record Dates
Results First Posted: December 12, 2016
Last Update Posted: December 12, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Osprey Medical, Inc:
Acute Kidney Injury
Iodinated Contrast Agent Retrieval
Coronary Sinus Cannulation