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

This study is currently recruiting participants.
Verified April 2013 by Osprey Medical, Inc
Sponsor:
Information provided by (Responsible Party):
Osprey Medical, Inc
ClinicalTrials.gov Identifier:
NCT01168024
First received: July 20, 2010
Last updated: April 29, 2013
Last verified: April 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Contrast Induced Nephropathy
 Device: CINCOR™ System
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 ]

Estimated Enrollment: 600
Study Start Date: December 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CINCOR™ System Treatment
Use of the CINCOR™ System during the PCI procedure plus Standard of Care peri-procedural hydration for the prevention of CIN.
 Device: CINCOR™ System
Catheter based system to reduce and remove contrast media.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01168024

Contacts
Contact: Mike McCormick 952-955-8231 mmccormick@ospreymed.com

Locations
United States, Alabama
Heart Care Research, LLC Recruiting
Huntsville, Alabama, United States, 35801
Contact: Alejandro Vasquez, M.D.         avasquez@theheartcenter.md    
Principal Investigator: Alejandro Vasquez, M.D.            
United States, Arizona
St. Luke's Medical Center Recruiting
Phoenix, Arizona, United States, 85006
Contact: Richard Heuser, M.D.         rheuser@iasishealthcare.com    
Principal Investigator: Richard Heuser, M.D.            
Sub-Investigator: Mansour Assar, M.D.            
United States, California
Harbor UCLA Recruiting
Torrance, California, United States, 90502
Contact: Joseph Thomas, M.D.         jthomas@labiomed.org    
Principal Investigator: Joseph Thomas, M.D.            
United States, Florida
Infinity Clinical Research Recruiting
Hollywood, Florida, United States, 33021
Contact: Juan Pastor, M.D.         apastor@pol.net    
Principal Investigator: Juan Pastor, M.D.            
United States, Minnesota
St. Mary's Medical Center Recruiting
Duluth, Minnesota, United States, 55805
Contact: Mudassar Ahmed, M.D.         Mudassar.ahmed@essentiahealth.org    
Principal Investigator: Mudassar Ahmed, M.D.            
United States, Tennessee
Tennova Healthcare - Turkey Creek Medical Center Recruiting
Knoxville, Tennessee, United States, 37934
Contact: Malcolm Foster, M.D.         malcolm.foster@ethc.com    
Principal Investigator: Malcolm Foster, M.D.            
United States, Virginia
Sentara Norfolk General Hospital Recruiting
Norfolk, Virginia, United States, 23507
Contact: Paul Mahoney, M.D.         Pmahoney22@yahoo.com    
Principal Investigator: Paul Mahoney, M.D.            
Germany
Cardiology Center Leipzig Ltd. Recruiting
Leipzig, Saxony, Germany, 04289
Contact: Steffen Desch, M.D.         stdesch@web.de    
Principal Investigator: Steffen Leipzig, M.D.            
Sponsors and Collaborators
Osprey Medical, Inc
  More Information

No publications provided

Responsible Party: Osprey Medical, Inc
ClinicalTrials.gov Identifier: NCT01168024     History of Changes
Other Study ID Numbers: TP-6142
Study First Received: July 20, 2010
Last Updated: April 29, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Osprey Medical, Inc:
Acute Kidney Injury
Iodinated Contrast Agent Retrieval
Coronary Sinus Cannulation

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 21, 2013