Contrast Induced Nephropathy (CIN) Clinical Trial
— AVERT™Official title:
AVERT™ Clinical Trial
The Osprey Medical AVERT System is indicated to reduce contrast media (CM) exposure to the kidneys during percutaneous coronary procedures thereby reducing the risk of contrast induced nephropathy (CIN).
| Status | Completed |
| Enrollment | 578 |
| Est. completion date | September 2015 |
| Est. primary completion date | July 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - The subject is a candidate for a therapeutic percutaneous coronary intervention (PCI) procedure. - The subject has documented chronic kidney disease (CKD) Exclusion Criteria: - Subject is in acute renal failure - Assessment of ventricular function that cannot be accomplished without the use of the CM. - Subject has acute STEMI within 72 hours prior to planned PCI procedure, or is currently having an acute STEMI. - Subject is unable to undergo peri-procedural hydration. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Australia | Heart Center Alfred Hospital | Melbourne | Victoria |
| New Zealand | Auckland City Hospital | Auckland | |
| United States | Emory University Hospital Midtown | Atlanta | Georgia |
| United States | St. Joseph's Hospital (Emory) | Atlanta | Georgia |
| United States | University of Chicago Medical Center | Chicago | Illinois |
| United States | University of Illinois at Chicago | Chicago | Illinois |
| United States | The Heart & Vascular Institute of Florida | Clearwater | Florida |
| United States | Providence Cardiology LLC | Columbia | South Carolina |
| United States | VA North Texas Health Care System | Dallas | Texas |
| United States | LeBauer Cardiovascular Research Foundation | Greensboro | North Carolina |
| United States | CHI St. Luke's Health / Baylor St. Luke's Medical Center | Houston | Texas |
| United States | Houston Methodist Hospital | Houston | Texas |
| United States | St. Vincent's Ambulatory Care (dba St. Vincent's Cardiology) | Jacksonville | Florida |
| United States | University of FL College of Medicine - Jacksonville | Jacksonville | Florida |
| United States | Saint Luke's Hospital | Kansas City | Missouri |
| United States | UCSD Medical Center | La Jolla | California |
| United States | Long Beach CA VA Hospital | Long Beach | California |
| United States | Kaiser Permanente Los Angeles Medical Center | Los Angeles | California |
| United States | Jewish Hospital | Louisville | Kentucky |
| United States | Norton Cardiovascular Associates | Louisville | Kentucky |
| United States | Coliseum Medical Center | Macon | Georgia |
| United States | Baptist Memorial Hospital | Memphis | Tennessee |
| United States | Minneapolis Heart Institute Foundation / Abbott Northwestern Hospital | Minneapolis | Minnesota |
| United States | Ochsner Clinic Foundation | New Orleans | Louisiana |
| United States | Mount Sinai Hospital | New York | New York |
| United States | Sentara Cardiovascular Research Institute / Norfolk General | Norfolk | Virginia |
| United States | Oklahoma Heart | Oklahoma City | Oklahoma |
| United States | Allegheny General Hospital | Pittsburgh | Pennsylvania |
| United States | The Heart Hospital Baylor Plano | Plano | Texas |
| United States | NC Heart and Vascular Research | Raleigh | North Carolina |
| United States | Mayo Clinic Hospital, St. Mary's Campus | Rochester | Minnesota |
| United States | U of TX Health Science Center San Antonio (UTHSCSA) | San Antonio | Texas |
| United States | Gateway Cardiovascular Research Center, Inc. | St. Louis | Missouri |
| United States | Stanford Hospital and Clinics | Stanford | California |
| United States | Tallahassee Research Institute, Inc. | Tallahassee | Florida |
| United States | Harbor UCLA Medical Center | Torrance | California |
| United States | North Mississippi Medical Center | Tupelo | Mississippi |
| United States | Trinity Mother Frances/Cardiovascular Associates of East Texas PA | Tyler | Texas |
| United States | York Hospital | York | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Osprey Medical, Inc |
United States, Australia, New Zealand,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Primary Effectiveness Endpoint | Reduction in the incidence of Contrast Induced Nephropathy (CIN) | 3 days | No |
| Primary | Primary Safety Endpoint | Incidence of device related serious adverse events | 30 days | Yes |
| Secondary | Secondary Endpoint 1 | Reduction in volume contrast media required | 30 Days | No |
| Secondary | Secondary Endpoint 2 | Comparing event rates of major adverse events. | 30 Days | Yes |
| Secondary | Secondary Endpoint 3 | Change in kidney function. | 3 days | No |