Contrast Media Reduction and Removal in Patients With 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: February 7, 2014
Last verified: February 2014

July 20, 2010
February 7, 2014
December 2012
October 2014   (final data collection date for primary outcome measure)
  • Reduction in the incidence of CIN in subjects. [ Time Frame: Through 72 hours post-procedure ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

    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. ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

    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. ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: No ]
Compare the mean change in serum creatinine between the two treatment groups post-procedure. [ Time Frame: Up to 96 hours post-procedure ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Contrast Media Reduction and Removal in Patients With 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
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Contrast Induced Nephropathy
  • Device: CINCOR™ System
    Catheter based system to reduce and remove contrast media.
  • Drug: Peri-procedural hydration
    Parenteral administration of fluids (saline or bicarbonate solutions) prior to and after a PCI procedure. This is considered to be minimum standard of care for CIN prevention.
  • Experimental: CINCOR™ System Treatment
    Use of the CINCOR™ System during the PCI procedure plus Standard of Care peri-procedural hydration for the prevention of CIN.
    Intervention: Device: CINCOR™ System
  • Active Comparator: 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.
    Intervention: Drug: 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
17
November 2014
October 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • The subject is a candidate for a therapeutic percutaneous coronary intervention (PCI) procedure of the left coronary artery.
  • The subject has documented chronic kidney disease (CKD).
  • The subject is willing and able to provide appropriate informed consent.
  • The subject is willing and able to comply with the requirements of the study protocol, including the predefined follow-up evaluations.

Exclusion Criteria:

  • The subject has unstable renal function (acute renal failure).
  • The subject has received contrast media within 7 days of the procedure.
  • The subject will receive iodinated contrast media in any location other than the Left Coronary Artery during the procedure or within a period of 30 days after the procedure.
  • Hemoglobin <9.5 g/dL
  • Requires hemodialysis
  • The subject has had acute myocardial infarction (heart attack) within last 24 hours.
  • The subject is known to be or suspected to be pregnant.
  • The subject is currently participating in another investigational device or drug study that has not reached its primary endpoint.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany
 
NCT01168024
TP-6142
Yes
Osprey Medical, Inc
Osprey Medical, Inc
Not Provided
Not Provided
Osprey Medical, Inc
February 2014

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