Recruitment

Recruitment Status
Completed
Estimated Enrollment
700

Inclusion Criterias

The subject is a candidate for a therapeutic percutaneous coronary intervention (PCI) procedure.
The subject has documented chronic kidney disease (CKD)
The subject is a candidate for a therapeutic percutaneous coronary intervention (PCI) procedure.
The subject has documented chronic kidney disease (CKD)

Exclusion Criterias

Assessment of ventricular function that cannot be accomplished without the use of the CM.
Subject is unable to undergo peri-procedural hydration.
Subject is in acute renal failure
...
Assessment of ventricular function that cannot be accomplished without the use of the CM.
Subject is unable to undergo peri-procedural hydration.
Subject is in acute renal failure
Subject has acute STEMI within 72 hours prior to planned PCI procedure, or is currently having an acute STEMI.

Summary

Conditions
Contrast Induced Nephropathy (CIN)
Type
Interventional
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Participant)
  • Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

The purpose of this trial is to assess the AVERT System device, which is designed to limit the volume of CM (Contrast Media) utilized, during a staged therapeutic coronary PCI (Percutaneous Coronary Intervention) or a coronary diagnostic procedure that is anticipated to become a PCI (i.e. ad hoc PCI...

The purpose of this trial is to assess the AVERT System device, which is designed to limit the volume of CM (Contrast Media) utilized, during a staged therapeutic coronary PCI (Percutaneous Coronary Intervention) or a coronary diagnostic procedure that is anticipated to become a PCI (i.e. ad hoc PCI) for the reduction of CIN (Contrast Induced Nephropathy).

Inclusion Criterias

The subject is a candidate for a therapeutic percutaneous coronary intervention (PCI) procedure.
The subject has documented chronic kidney disease (CKD)
The subject is a candidate for a therapeutic percutaneous coronary intervention (PCI) procedure.
The subject has documented chronic kidney disease (CKD)

Exclusion Criterias

Assessment of ventricular function that cannot be accomplished without the use of the CM.
Subject is unable to undergo peri-procedural hydration.
Subject is in acute renal failure
...
Assessment of ventricular function that cannot be accomplished without the use of the CM.
Subject is unable to undergo peri-procedural hydration.
Subject is in acute renal failure
Subject has acute STEMI within 72 hours prior to planned PCI procedure, or is currently having an acute STEMI.

Locations

Tupelo, Mississippi, 38801
Pittsburgh, Pennsylvania, 15212
Jacksonville, Florida, 32209
Dallas, Texas, 75216
Clearwater, Florida, 33756
...
Tupelo, Mississippi, 38801
Pittsburgh, Pennsylvania, 15212
Jacksonville, Florida, 32209
Dallas, Texas, 75216
Clearwater, Florida, 33756
Long Beach, California, 90812
Atlanta, Georgia, 30342
San Antonio, Texas, 78229-3900
Norfolk, Virginia, 23507
Plano, Texas, 75093
Chicago, Illinois, 60612
Tyler, Texas, 75701
Memphis, Tennessee, 38120
Houston, Texas, 77030
Atlanta, Georgia, 30308
Torrance, California, 90509
Minneapolis, Minnesota, 55407
Rochester, Minnesota, 55902
Louisville, Kentucky, 40202
Oklahoma City, Oklahoma, 73120
Louisville, Kentucky, 40205
Los Angeles, California, 90027
Tallahassee, Florida, 32308
New Orleans, Louisiana, 70121
New York, New York, 10029
Jacksonville, Florida, 32216
St. Louis, Missouri, 63128
Auckland, 1023
Houston, Texas, 77030
Raleigh, North Carolina, 27610
Kansas City, Missouri, 64111
Melbourne, Victoria, 3004
Stanford, California, 94305-5218
Macon, Georgia, 31217
Greensboro, North Carolina, 27401
York, Pennsylvania, 17405
La Jolla, California, 92037
Chicago, Illinois, 60637
Columbia, South Carolina, 29204

Tracking Information

NCT #
NCT01976299
Collaborators
Not Provided
Investigators
  • Principal Investigator: Roxana Mehran, MD, FACC Icahn School of Medicine at Mount Sinai
  • Roxana Mehran, MD, FACC Icahn School of Medicine at Mount Sinai