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

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ClinicalTrials.gov Identifier: NCT01168024
Recruitment Status : Terminated (Study closed by sponsor prior to completing enrollment goal.)
First Posted : July 22, 2010
Results First Posted : December 12, 2016
Last Update Posted : December 12, 2016
Sponsor:
Information provided by (Responsible Party):
Osprey Medical, Inc

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
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CINCOR™ System and CCS-1 Standard of Care Plus Peri-procedural Hydration
Hide Arm/Group Description 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. Peri-procedural hydration utilized prior to standard of care PCI.
Period Title: Overall Study
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.
Arm/Group Title CINCOR™ System Treatment Standard of Care Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 13 3 16
Hide Baseline Analysis Population Description
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.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 3 participants 16 participants
67.2  (11.5) 82  (13.8) 71  (11.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 3 participants 16 participants
Female
3
  23.1%
1
  33.3%
4
  25.0%
Male
10
  76.9%
2
  66.7%
12
  75.0%
1.Primary Outcome
Title Incidence of Contrast Induced Nephropathy (CIN) in Subjects.
Hide Description CIN is defined as a post-procedure relative serum creatinine increase ≥ 25% or an absolute serum creatinine increase of ≥ 0.5 mg/dL).
Time Frame Through 72 hours post-procedure
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Roll In and Randomized) Control
Hide Arm/Group Description:
CINCOR, CCS-1 and Peri-procedure hydration
Peri-procedure hydration
Overall Number of Participants Analyzed 13 3
Measure Type: Number
Unit of Measure: participants
2 1
2.Primary Outcome
Title Evaluating Bleeding/Transfusion Events.
Hide Description

Bleeding/transfusion events evaluated:

  • Blood loss requiring transfusion of ≥ 2 units
  • Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding
  • TIMI Minor Bleeding
Time Frame Through 30 days post-procedure
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Roll In and Randomized) Control
Hide Arm/Group Description:
CINCOR, CCS-1 and Peri-procedure hydration
Peri-procedure hydration
Overall Number of Participants Analyzed 13 3
Measure Type: Number
Unit of Measure: events
0 0
3.Primary Outcome
Title Evaluating Local Events.
Hide Description

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
Time Frame Through 30 days post-procedure.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Roll In and Randomized) Control
Hide Arm/Group Description:
CINCOR, CCS-1 and Peri-procedure hydration
Peri-procedure hydration
Overall Number of Participants Analyzed 13 3
Measure Type: Number
Unit of Measure: events
0 0
4.Secondary Outcome
Title Change in Kidney Function Between the Randomized Groups.
Hide Description [Not Specified]
Time Frame Up to 96 hours post-procedure
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Change in eGFR was available for 2 treatment and 1 control subject. 1 out of range eGFR value for a subject (0.1) was not used as this value is not clinically feasible.
Arm/Group Title Treatment (Roll In and Randomized) Control
Hide Arm/Group Description:
CINCOR, CCS-1 and Peri-procedure hydration
Peri-procedure hydration
Overall Number of Participants Analyzed 1 2
Mean (Standard Deviation)
Unit of Measure: mL/min/1.73m^2
-6.33  (1.10) -6.95  (3.61)
Time Frame Adverse events were reported through the 30 day follow up period.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Roll In and Randomized) Control
Hide Arm/Group Description CINCOR, CCS-1 and Peri-procedure hydration Peri-procedure hydration
All-Cause Mortality
Treatment (Roll In and Randomized) Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Roll In and Randomized) Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/13 (15.38%)      0/3 (0.00%)    
Cardiac disorders     
STEMI *  1/13 (7.69%)  1 0/3 (0.00%)  0
Dizziness *  1/13 (7.69%)  1 0/3 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment (Roll In and Randomized) Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/13 (23.08%)      0/3 (0.00%)    
Cardiac disorders     
Chest Pain *  1/13 (7.69%)  1 0/3 (0.00%)  0
Troponin Elevation *  1/13 (7.69%)  1 0/3 (0.00%)  0
Minor Bleeding *  1/13 (7.69%)  1 0/3 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
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
Responsible Party: Osprey Medical, Inc
ClinicalTrials.gov Identifier: NCT01168024     History of Changes
Other Study ID Numbers: TP-6142
First Submitted: July 20, 2010
First Posted: July 22, 2010
Results First Submitted: June 27, 2016
Results First Posted: December 12, 2016
Last Update Posted: December 12, 2016