Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

Condition Intervention
Radiographic Contrast Agent Nephropathy
Device: CINCOR™ System and contrast conservation unit (CCS-1)
Other: Standard of Care plus peri-procedural hydration

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group 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

Resource links provided by NLM:


Further study details as provided by Osprey Medical, Inc:

Primary Outcome Measures:
  • Incidence of Contrast Induced Nephropathy (CIN) in Subjects. [ Time Frame: 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).

  • Evaluating Bleeding/Transfusion Events. [ Time Frame: 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

  • Evaluating Local Events. [ Time Frame: 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


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

Enrollment: 16
Study Start Date: December 2012
Study Completion Date: November 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CINCOR™ System Treatment
Use of the CINCOR™ System and CCS-1 device during the pericutanous coronary intervention (PCI) procedure plus Standard of Care peri-procedural hydration for the prevention of contrast induced nephropathy (CIN).
Device: CINCOR™ System and contrast conservation unit (CCS-1)
Catheter based system to reduce and remove contrast media and contrast modulator to reduce contrast media
Other: Standard of Care plus peri-procedural hydration
The control group will receive a peri and post-procedural hydration rate.
Standard of Care
The control group will receive a peri and post-procedural hydration rate.
Other: Standard of Care plus peri-procedural hydration
The control group will receive a peri and post-procedural hydration rate.

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   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The subject is at least 18 years of age.
  2. The subject is a candidate for a therapeutic coronary PCI procedure of the left coronary artery and/or its branches or a combination procedure including left coronary artery/branches AND right coronary artery that is expected to utilize at least 50 mL of iodinated contrast media.
  3. The subject has baseline eGFR between 20 and 30 mL/min/1.73 m2 inclusive (as determined by the MDRD equation (Levey 1993)); or patient has eGFR above 30 but less than or equal to 60 with at least two of the following: stage III/IV NYHA congestive heart failure, diabetes mellitus, hypertension, age of at least 75 years.
  4. The subject (or subject's legal representative) is willing and able to provide appropriate informed consent.
  5. The subject is willing and able to comply with the requirements of the study protocol, including the predefined follow-up evaluations.

Exclusion Criteria:

  1. The subject has unstable renal function (acute renal failure or change in serum creatinine of > 0.5mg/dL or > 25% within 7 days of the procedure not attributed to hydration therapy).
  2. The subject requires dialysis.
  3. The subject has received contrast media within 7 days of the procedure.
  4. The subject will receive > 10 ml of iodinated contrast media in any location other than the coronary arteries (e.g. ventriculography, aortography, renal angiography) during the procedure or within a period of 30 days after the procedure.
  5. The subject requires one or more of the following nephrotoxic agents: Aminoglycoside antibiotics, Sulfonamides, Amphotericin B, Levofloxacin, Ciprofloxacin, Rifampin, Tetracycline, Intravenous Acyclovir, Pentamidine, Penicillin and Cephalosporins, Cisplatin, Methotrexate, Mitomycin, Cyclosporine, Tacrolimus.
  6. The subject has hemoglobin (Hb) < 9.5 g/dL within one (1) week of the procedure.
  7. The subject is hemodynamically unstable or requires hemodynamic support including intra-venous inotropes, vasopressors, or any type of ventricular assist devices (including intra-aortic balloon pumps, the Impella cardiac assist device, the TandemHeart VAD, and surgically implanted ventricular assist devices).
  8. The subject has had acute myocardial infarction within last 24 hours (as defined in the "Universal Definition of Myocardial Infarction (Thygesen 2007) or has biomarkers of cardiac injury that have not stabilized. (Patients with MI within 96 hours of index procedure must demonstrate falling biomarkers of cardiac injury).
  9. The subject has any of the following procedural contra-indications

    1. has a left heart pacing lead or other implant indwelling in the coronary sinus or has had an artificial valve or pacemaker lead implanted in the right heart within 8 weeks of the planned procedure
    2. has a known bleeding diathesis (e.g. thrombocytopenia [<100,000 cells/mm3], heparin-induced thrombocytopenia, hemophilia, or von Willebrand disease, any history of intracranial bleeding, or gastrointestinal or gross genitourinary bleeding)
    3. The subject is currently on intravenous anti-coagulation that cannot be discontinued prior to the procedure
    4. The subject has a known hypersensitivity to both heparin and bivalirudin or aspirin or all thienopyridine agents or iodinated contrast that cannot be adequately pre-medicated
    5. The subject has an active systemic infection
    6. The subject refuses to accept blood products (e.g. Jehovah's Witness)
  10. The subject is known to be or suspected to be pregnant, or is lactating (all women of child-bearing potential must have a negative pregnancy test within 72 hours before participating in this protocol).
  11. The subject is currently participating in another investigational device or drug study that has not reached its primary endpoint.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
United States, Alabama
Heart Care Research, LLC
Huntsville, Alabama, United States, 35801
United States, Arizona
St. Luke's Medical Center
Phoenix, Arizona, United States, 85006
United States, California
Kaiser Permanente
Los Angeles, California, United States, 90027
Stanford Hospitals and Clinics
Stanford, California, United States, 94305
Harbor UCLA
Torrance, California, United States, 90502
United States, Florida
The Heart and Vascular Institute of Florida
Clearwater, Florida, United States, 33753
Infinity Clinical Research
Hollywood, Florida, United States, 33021
United States, Georgia
Saint Joseph's Hospital of Atlanta
Atlanta, Georgia, United States, 30342
United States, Indiana
Franciscan St. Francis Health
Indianapolis, Indiana, United States, 46237
United States, Minnesota
St. Mary's Medical Center
Duluth, Minnesota, United States, 55805
United States, Ohio
Elyria Memorial Hospital Medical Center
Elyria, Ohio, United States, 44035
United States, Oklahoma
Oklahoma Foundation for Cardiovascular Research
Oklahoma City, Oklahoma, United States, 73120
United States, Pennsylvania
York Hospital
York, Pennsylvania, United States, 17405
United States, South Carolina
South Carolina Heart Center
Columbia, South Carolina, United States, 29204
Greenville Health System
Greenville, South Carolina, United States, 29605
United States, Tennessee
Tennova Healthcare - Turkey Creek Medical Center
Knoxville, Tennessee, United States, 37934
United States, Texas
The Methodist Hospital of Research
Houston, Texas, United States, 77030
Cardiovascular Associates of East Texas, PA
Tyler, Texas, United States, 75701
United States, Virginia
Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
United States, West Virginia
Charleston Area Medical Center
Charleston, West Virginia, United States, 25304
Germany
Cardiology Center Leipzig Ltd.
Leipzig, Saxony, Germany, 04289
Sponsors and Collaborators
Osprey Medical, Inc
Investigators
Principal Investigator: Gregg Stone, MD CRF
  More Information

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
Individual Participant Data  
Plan to Share IPD: No

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

ClinicalTrials.gov processed this record on May 22, 2017