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

• ClinicalTrials.gov Identifier: NCT01168024
• Recruitment Status: Terminated
• First Posted: July 22, 2010
• Results First Posted: December 12, 2016
• Last Update Posted: December 12, 2016
• Sponsor: Osprey Medical, Inc
• Information provided by (Responsible Party): Osprey Medical, Inc

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Radiographic Contrast Agent Nephropathy	Device: CINCOR™ System and contrast conservation unit (CCS-1); Other: Standard of Care plus peri-procedural hydration	Not Applicable

Detailed Description:

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: December 2012
• Actual Primary Completion Date: October 2013
• Actual Study Completion Date: November 2013

Arms and Interventions

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.
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.

Outcome Measures

Primary Outcome Measures :

1. 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).
2. 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
3. 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 :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

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
• Other Study ID Numbers: TP-6142
• First Posted: July 22, 2010
• Results First Posted: December 12, 2016
• Last Update Posted: December 12, 2016
• Last Verified: October 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Osprey Medical, Inc:

Acute Kidney Injury; Iodinated Contrast Agent Retrieval; Coronary Sinus Cannulation

Additional relevant MeSH terms:

Kidney Diseases; Urologic Diseases