Try our beta test site

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

This study has been terminated.
(Study closed by sponsor prior to completing enrollment goal.)
Sponsor:
Information provided by (Responsible Party):
Osprey Medical, Inc
ClinicalTrials.gov Identifier:
NCT01168024
First received: July 20, 2010
Last updated: October 18, 2016
Last verified: October 2016

July 20, 2010
October 18, 2016
December 2012
October 2013   (Final data collection date for primary outcome measure)
  • 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).
  • 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
  • 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
  • Demonstrate a reduction in the incidence of CIN in subjects in which the CINCOR™ System is utilized compared to the control group receiving standard of care medical practice. [ Time Frame: Through 96 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).
  • Demonstrate the safety of the CINCOR™ System by evaluating bleeding/transfusion events compared to the control group. [ 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
  • To demonstrate the safety of the CINCOR™ System by evaluating local events caused by system placement and/or use. [ 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
Complete list of historical versions of study NCT01168024 on ClinicalTrials.gov Archive Site
Change in Kidney Function Between the Randomized Groups. [ Time Frame: Up to 96 hours post-procedure ]
Compare the mean change in serum creatinine between the two treatment groups post-procedure. [ Time Frame: Up to 96 hours post-procedure ]
Not Provided
Not Provided
 
Contrast Media Reduction and Removal in Patients With Chronic Kidney Disease (CKD) (PRESERV)
PRESERV (Prospective Randomized Evaluation to Study the Effects of Reduced Contrast Media on the Vitality of the Kidney) Pivotal Trial
The purpose of this clinical trial is to demonstrate the efficacy and safety of the Osprey Medical CINCOR™ Contrast Removal System.
The CINCOR™ Catheter System to retrieve contrast media from the coronary sinus following injection during percutaneous coronary interventions.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Radiographic Contrast Agent Nephropathy
  • 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.
  • 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).
    Interventions:
    • Device: CINCOR™ System and contrast conservation unit (CCS-1)
    • Other: Standard of Care plus peri-procedural hydration
  • Standard of Care
    The control group will receive a peri and post-procedural hydration rate.
    Intervention: Other: Standard of Care plus peri-procedural hydration
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
16
November 2013
October 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany
 
 
NCT01168024
TP-6142
Yes
Not Provided
No
Not Provided
Osprey Medical, Inc
Osprey Medical, Inc
Not Provided
Principal Investigator: Gregg Stone, MD CRF
Osprey Medical, Inc
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP