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

Radiographic Contrast Agent Nephropathy Clinical Trial

Official title:

PRESERV (Prospective Randomized Evaluation to Study the Effects of Reduced Contrast Media on the Vitality of the Kidney) Pivotal Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01168024
• Other study ID #: TP-6142
• Status: Terminated
• Phase: Phase 3
• First received: July 20, 2010
• Last updated: May 18, 2016
• Start date: December 2012
• Est. completion date: November 2013

Study information

• Verified date: May 2016
• Source: Osprey Medical, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this clinical trial is to demonstrate the efficacy and safety of the Osprey Medical CINCOR™ Contrast Removal System.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: November 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Radiographic Contrast Agent Nephropathy

Intervention

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.

Locations

Country	Name	City	State
Germany	Cardiology Center Leipzig Ltd.	Leipzig	Saxony
United States	Saint Joseph's Hospital of Atlanta	Atlanta	Georgia
United States	Charleston Area Medical Center	Charleston	West Virginia
United States	The Heart and Vascular Institute of Florida	Clearwater	Florida
United States	South Carolina Heart Center	Columbia	South Carolina
United States	St. Mary's Medical Center	Duluth	Minnesota
United States	Elyria Memorial Hospital Medical Center	Elyria	Ohio
United States	Greenville Health System	Greenville	South Carolina
United States	Infinity Clinical Research	Hollywood	Florida
United States	The Methodist Hospital of Research	Houston	Texas
United States	Heart Care Research, LLC	Huntsville	Alabama
United States	Franciscan St. Francis Health	Indianapolis	Indiana
United States	Tennova Healthcare - Turkey Creek Medical Center	Knoxville	Tennessee
United States	Kaiser Permanente	Los Angeles	California
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	Oklahoma Foundation for Cardiovascular Research	Oklahoma City	Oklahoma
United States	St. Luke's Medical Center	Phoenix	Arizona
United States	Stanford Hospitals and Clinics	Stanford	California
United States	Harbor UCLA	Torrance	California
United States	Cardiovascular Associates of East Texas, PA	Tyler	Texas
United States	York Hospital	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Osprey Medical, Inc

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in the incidence of CIN in subjects.	CIN is defined as a post-procedure relative serum creatinine increase = 25% or an absolute serum creatinine increase of = 0.5 mg/dL).	Through 72 hours post-procedure	No
Primary	Evaluating bleeding/transfusion events.	Bleeding/transfusion events evaluated: Blood loss requiring transfusion of = 2 units; Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding; TIMI Minor Bleeding	Through 30 days post-procedure	Yes
Primary	Evaluating local events.	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	Through 30 days post-procedure.	Yes
Secondary	Change in kidney function between the randomized groups.		Up to 96 hours post-procedure	No