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

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

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

Study Overview

• Status: Terminated
• Conditions: Radiographic Contrast Agent Nephropathy
• Intervention / Treatment: Device: CINCOR™ System and contrast conservation unit (CCS-1); Other: Standard of Care plus peri-procedural hydration

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
OTHER: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Contrast Induced Nephropathy (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
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
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.

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in Kidney Function Between the Randomized Groups.	Up to 96 hours post-procedure

Collaborators and Investigators

• Sponsor: Osprey Medical, Inc
• Investigators: Principal Investigator: Gregg Stone, MD, CRF

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (ACTUAL): October 1, 2013
• Study Completion (ACTUAL): November 1, 2013

Study Registration Dates

• First Submitted: July 20, 2010
• First Submitted That Met QC Criteria: July 21, 2010
• First Posted (ESTIMATE): July 22, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): December 12, 2016
• Last Update Submitted That Met QC Criteria: October 18, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Acute Kidney Injury; Iodinated Contrast Agent Retrieval; Coronary Sinus Cannulation
• Additional Relevant MeSH Terms: Urologic Diseases; Kidney Diseases
• Other Study ID Numbers: TP-6142

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO