Trial Outcomes & Findings for Contrast Media Reduction and Removal in Patients With Chronic Kidney Disease (CKD) (PRESERV) (NCT NCT01168024)

NCT ID: NCT01168024

Last Updated: 2016-12-12

Results Overview

CIN is defined as a post-procedure relative serum creatinine increase ≥ 25% or an absolute serum creatinine increase of ≥ 0.5 mg/dL).

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 16 participants
• Primary outcome timeframe: Through 72 hours post-procedure
• Results posted on: 2016-12-12

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	13	3
Overall Study COMPLETED	13	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	CINCOR™ System Treatment n=13 Participants 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 n=3 Participants 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 n=16 Participants Total of all reporting groups
Age, Continuous	67.2 years STANDARD_DEVIATION 11.5 • n=5 Participants	82 years STANDARD_DEVIATION 13.8 • n=7 Participants	71 years STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	2 Participants n=7 Participants	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: Through 72 hours post-procedure

CIN is defined as a post-procedure relative serum creatinine increase ≥ 25% or an absolute serum creatinine increase of ≥ 0.5 mg/dL).

Outcome measures

Measure	Treatment (Roll In and Randomized) n=13 Participants CINCOR, CCS-1 and Peri-procedure hydration	Control n=3 Participants Peri-procedure hydration
Incidence of Contrast Induced Nephropathy (CIN) in Subjects.	2 participants	1 participants

PRIMARY outcome

Timeframe: Through 30 days post-procedure

Bleeding/transfusion events evaluated:

• Blood loss requiring transfusion of ≥ 2 units
• Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding
• TIMI Minor Bleeding

Outcome measures

Measure	Treatment (Roll In and Randomized) n=13 Participants CINCOR, CCS-1 and Peri-procedure hydration	Control n=3 Participants Peri-procedure hydration
Evaluating Bleeding/Transfusion Events.	0 events	0 events

PRIMARY outcome

Timeframe: Through 30 days post-procedure.

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

Outcome measures

Measure	Treatment (Roll In and Randomized) n=13 Participants CINCOR, CCS-1 and Peri-procedure hydration	Control n=3 Participants Peri-procedure hydration
Evaluating Local Events.	0 events	0 events

SECONDARY outcome

Timeframe: Up to 96 hours post-procedure

Population: 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.

Outcome measures

Measure	Treatment (Roll In and Randomized) n=1 Participants CINCOR, CCS-1 and Peri-procedure hydration	Control n=2 Participants Peri-procedure hydration
Change in Kidney Function Between the Randomized Groups.	-6.33 mL/min/1.73m^2 Standard Deviation 1.10	-6.95 mL/min/1.73m^2 Standard Deviation 3.61

Adverse Events

Treatment (Roll In and Randomized)

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment (Roll In and Randomized) n=13 participants at risk CINCOR, CCS-1 and Peri-procedure hydration	Control n=3 participants at risk Peri-procedure hydration
Cardiac disorders STEMI	7.7% 1/13 • Number of events 1 • Adverse events were reported through the 30 day follow up period.	0.00% 0/3 • Adverse events were reported through the 30 day follow up period.
Cardiac disorders Dizziness	7.7% 1/13 • Number of events 1 • Adverse events were reported through the 30 day follow up period.	0.00% 0/3 • Adverse events were reported through the 30 day follow up period.

Other adverse events

Measure	Treatment (Roll In and Randomized) n=13 participants at risk CINCOR, CCS-1 and Peri-procedure hydration	Control n=3 participants at risk Peri-procedure hydration
Cardiac disorders Chest Pain	7.7% 1/13 • Number of events 1 • Adverse events were reported through the 30 day follow up period.	0.00% 0/3 • Adverse events were reported through the 30 day follow up period.
Cardiac disorders Troponin Elevation	7.7% 1/13 • Number of events 1 • Adverse events were reported through the 30 day follow up period.	0.00% 0/3 • Adverse events were reported through the 30 day follow up period.
Cardiac disorders Minor Bleeding	7.7% 1/13 • Number of events 1 • Adverse events were reported through the 30 day follow up period.	0.00% 0/3 • Adverse events were reported through the 30 day follow up period.

Additional Information

VP Of Clinial Affairs

Osprey Medical

Phone: 952-955-8230

Email: mshepard@ospreymed.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place