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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 December 02, 2016