Low Frequency Therapeutic Ultrasound System Pivotal Clinical Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Contrast-induced Nephropathy
- Sponsor
- Sonogenix
- Enrollment
- 2
- Locations
- 4
- Primary Endpoint
- Primary Efficacy Endpoint
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
Brief Summary
Multi-center randomized trial to assess the safety and performance of low-frequency therapeutic ultrasound for maintaining renal function after contrast exposure.
Detailed Description
This is a multi-center, randomized, controlled clinical trial designed to assess the safety and performance of the Sonogenix RENOBOOST as an adjunctive therapy for maintaining renal function after contrast exposure. The trial will enroll up to 234 subjects not taking oral nitrates and at high-risk of developing PC-AKI undergoing coronary arteriography for a planned percutaneous coronary intervention in up to 10 clinical sites in the US and up to 3 clinical sites outside the US. All subjects will be pre- treated with 0.9 percent NaCl at 3 ml/kg/h 1 hour before and 1 ml/kg/h during and 6 hours post procedure. Participants will be randomized in a 2:1 fashion to either active adjunctive therapy with the Sonogenix RENOBOOST or sham control. Subjects will have clinical follow-up examination 30 days post index procedure.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participant is greater than or equal to 18 years
- •Baseline renal dysfunction defined as one of the following:
- •eGFR greater than 30
- •eGFR 30-45, with or without risk factors for AKI defined as diabetes mellitus, congestive heart failure, proteinuria (defined as albuminuria greater than 300mg/day).
- •eGFR 45-60, with at least one risk factor for AKI defined as diabetes mellitus, congestive heart failure, proteinuria (defined as albuminuria greater than 300mg/day).
- •Participant is presenting for a planned percutaneous coronary intervention (PCI)
- •Participant scheduled to undergo cardiac catheterization including coronary arteriography that is anticipated to require at least 100 ml of iso-osmolar or low- osmolar contrast, and that is anticipated to include single-vessel stent implantation that does not include chronic total occlusion.
- •Participant had not been hospitalized or treated for a change in renal function within 30 days of enrollment.
- •Participant has provided written informed consent.
- •Participant is willing to comply with study follow-up requirements.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Primary Efficacy Endpoint
Time Frame: 48 hours
Incidence of acute kidney injury (AKI) defined as a greater than 0.3 mg/dl increase in serum creatinine (SCr)
Primary Safety Endpoint
Time Frame: 30 days
Composite of all Adverse Events (AE) including RENOBOOST (device) related adverse events, and major adverse events (MAE)
Secondary Outcomes
- Incidence of Post Contrast Acute Kidney Injury(within 96 hours post-contrast exposure or need for RRT)
- Incidence of contrast-induced nephropathy(within 96 hours post-contrast exposure or need for RRT)
- Hospitalization(following the baseline procedure through discharge from the hospital up to 30 days)
- Occurrence of (stage 1, 2, or 3) acute kidney injury (AKI)(within 96 hours of index procedure)
- Maximum percent-change(within 96 hours after contrast exposure)
- Absolute and percent-change in estimated glomerular filtration rate (eGFR)(from baseline within 96 hours after contrast exposure.)
- Total urine output(through baseline procedure)
- Intensive Care(following the baseline procedure through discharge from the Intensive Care Unit up to 30 days)