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

This study has been terminated.
(Study closed by sponsor prior to completing enrollment goal.)
Information provided by (Responsible Party):
Osprey Medical, Inc Identifier:
First received: July 20, 2010
Last updated: May 18, 2016
Last verified: May 2016
The purpose of this clinical trial is to demonstrate the efficacy and safety of the Osprey Medical CINCOR™ Contrast Removal System.

Condition Intervention Phase
Radiographic Contrast Agent Nephropathy
Device: CINCOR™ System and CCS-1
Drug: Peri-procedural hydration
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by Osprey Medical, Inc:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • Change in kidney function between the randomized groups. [ Time Frame: Up to 96 hours post-procedure ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: December 2012
Study Completion Date: November 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Device: CINCOR™ System and CCS-1
Catheter based system to reduce and remove contrast media and contrast modulator to reduce 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.
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.
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.

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01168024

  Show 21 Study Locations
Sponsors and Collaborators
Osprey Medical, Inc
Principal Investigator: Gregg Stone, MD CRF
  More Information

Responsible Party: Osprey Medical, Inc Identifier: NCT01168024     History of Changes
Other Study ID Numbers: TP-6142 
Study First Received: July 20, 2010
Last Updated: May 18, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Osprey Medical, Inc:
Acute Kidney Injury
Iodinated Contrast Agent Retrieval
Coronary Sinus Cannulation processed this record on October 28, 2016