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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
Results First Received: June 27, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Radiographic Contrast Agent Nephropathy
Interventions: Device: CINCOR™ System and contrast conservation unit (CCS-1)
Other: Standard of Care plus peri-procedural hydration

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
CINCOR™ System and CCS-1 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.
Standard of Care Plus Peri-procedural Hydration Peri-procedural hydration utilized prior to standard of care PCI.

Participant Flow:   Overall Study
    CINCOR™ System and CCS-1   Standard of Care Plus Peri-procedural Hydration
STARTED   13 [1]   3 
COMPLETED   13   3 
NOT COMPLETED   0   0 
[1] 13 tx/3 controls. Roll-ins occurred for product training, several more treatment cases than control.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Enrollment allowed for both non-randomized roll-in and randomized subjects. Up to three roll-in subjects (maximum of 150 in the trial) were allowed per center to address learning curve issues associated with the coronary sinus cannulation technique and device use.

Reporting Groups
  Description
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.

CINCOR™ System and CCS-1: Catheter based system to reduce and remove contrast media and contrast modulator to reduce contrast media

Peri-procedural hydration: The control group will receive a peri and post-procedural hydration rate.

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.

Peri-procedural hydration: The control group will receive a peri and post-procedural hydration rate.

Total Total of all reporting groups

Baseline Measures
   CINCOR™ System Treatment   Standard of Care   Total 
Overall Participants Analyzed 
[Units: Participants]
 13   3   16 
Age 
[Units: Years]
Mean (Standard Deviation)
 67.2  (11.5)   82  (13.8)   71  (11.1) 
Gender 
[Units: Participants]
     
Female   3   1   4 
Male   10   2   12 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Incidence of Contrast Induced Nephropathy (CIN) in Subjects.   [ Time Frame: Through 72 hours post-procedure ]

2.  Primary:   Evaluating Bleeding/Transfusion Events.   [ Time Frame: Through 30 days post-procedure ]

3.  Primary:   Evaluating Local Events.   [ Time Frame: Through 30 days post-procedure. ]

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: VP Of Clinial Affairs
Organization: Osprey Medical
phone: 952-955-8230
e-mail: mshepard@ospreymed.com



Responsible Party: Osprey Medical, Inc
ClinicalTrials.gov Identifier: NCT01168024     History of Changes
Other Study ID Numbers: TP-6142
Study First Received: July 20, 2010
Results First Received: June 27, 2016
Last Updated: October 18, 2016