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

NCT01168024 | Terminated Results DMC

• 1 other identifier: TP-6142
• Study Type: interventional
• Target: 16
• Locations: 2 countries
• Sites: 21

Brief Summary

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

Conditions

Radiographic Contrast Agent Nephropathy

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Change in Kidney Function Between the Randomized Groups.

  Up to 96 hours post-procedure

Study Arms (2)

CINCOR™ System Treatment

EXPERIMENTAL

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); Other: Standard of Care plus peri-procedural hydration

Standard of Care

OTHER

The control group will receive a peri and post-procedural hydration rate.

Other: Standard of Care plus peri-procedural hydration

Interventions

CINCOR™ System and contrast conservation unit (CCS-1) DEVICE

Catheter based system to reduce and remove contrast media and contrast modulator to reduce contrast media

CINCOR™ System Treatment

Standard of Care plus peri-procedural hydration OTHER

The control group will receive a peri and post-procedural hydration rate.

CINCOR™ System Treatment; Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject is at least 18 years of age.
• 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.
• 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.
• The subject (or subject's legal representative) 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.

You may not qualify if:

• 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).
• The subject requires dialysis.
• The subject has received contrast media within 7 days of the procedure.
• 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.
• 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.
• The subject has hemoglobin (Hb) \< 9.5 g/dL within one (1) week of the procedure.
• 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).
• 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).
• The subject has any of the following procedural contra-indications
• 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
• 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)
• The subject is currently on intravenous anti-coagulation that cannot be discontinued prior to the procedure
• 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
• The subject has an active systemic infection
• The subject refuses to accept blood products (e.g. Jehovah's Witness)

Sponsors & Collaborators

• Osprey Medical, Inc: lead

Study Sites (21)

Heart Care Research, LLC

Huntsville, Alabama, 35801, United States

Location

St. Luke's Medical Center

Phoenix, Arizona, 85006, United States

Location

Kaiser Permanente

Los Angeles, California, 90027, United States

Location

Stanford Hospitals and Clinics

Stanford, California, 94305, United States

Location

Harbor UCLA

Torrance, California, 90502, United States

Location

The Heart and Vascular Institute of Florida

Clearwater, Florida, 33753, United States

Location

Infinity Clinical Research

Hollywood, Florida, 33021, United States

Location

Saint Joseph's Hospital of Atlanta

Atlanta, Georgia, 30342, United States

Location

Franciscan St. Francis Health

Indianapolis, Indiana, 46237, United States

Location

St. Mary's Medical Center

Duluth, Minnesota, 55805, United States

Location

Elyria Memorial Hospital Medical Center

Elyria, Ohio, 44035, United States

Location

Oklahoma Foundation for Cardiovascular Research

Oklahoma City, Oklahoma, 73120, United States

Location

York Hospital

York, Pennsylvania, 17405, United States

Location

South Carolina Heart Center

Columbia, South Carolina, 29204, United States

Location

Greenville Health System

Greenville, South Carolina, 29605, United States

Location

Tennova Healthcare - Turkey Creek Medical Center

Knoxville, Tennessee, 37934, United States

Location

The Methodist Hospital of Research

Houston, Texas, 77030, United States

Location

Cardiovascular Associates of East Texas, PA

Tyler, Texas, 75701, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

Charleston Area Medical Center

Charleston, West Virginia, 25304, United States

Location

Cardiology Center Leipzig Ltd.

Leipzig, Saxony, 04289, Germany

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: VP Of Clinial Affairs
• Organization: Osprey Medical

mshepard@ospreymed.com

952-955-8230

Study Officials

• Gregg Stone, MD

  CRF

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2010
• First Posted: July 22, 2010
• Study Start: December 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: November 1, 2013
• Last Updated: December 12, 2016
• Results First Posted: December 12, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (20); DE (1)