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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Treatment | Experimental | Standard of Care with the AVERT system |
|
| Standard of Care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AVERT | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Primary Effectiveness Endpoint | Reduction in the incidence of Contrast Induced Nephropathy (CIN) by evaluating Serum Creatinine levels in subjects for up to 5 days. | 3-5 days |
| Primary Safety Endpoint- Number of Participants Experiencing a Device Related Serious Adverse Event | Analyze the incidence of device related serious adverse events within the treatment arm. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Endpoint 1- | Comparison in contrast media volume required between active treament and standard of care. | 30 Days |
| Secondary Endpoint 2- Comparison of Serious Adverse Events. | Comparing event rates of serious adverse events 30 days following the index procedure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roxana Mehran, MD, FACC | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD Medical Center | La Jolla | California | 92037 | United States | ||
| Long Beach CA VA Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30139467 | Derived | Mehran R, Faggioni M, Chandrasekhar J, Angiolillo DJ, Bertolet B, Jobe RL, Al-Joundi B, Brar S, Dangas G, Batchelor W, Prasad A, Gurm HS, Tumlin J, Stone GW. Effect of a Contrast Modulation System on Contrast Media Use and the Rate of Acute Kidney Injury After Coronary Angiography. JACC Cardiovasc Interv. 2018 Aug 27;11(16):1601-1610. doi: 10.1016/j.jcin.2018.04.007. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Treatment | Standard of Care with the AVERT system AVERT |
| FG001 | Standard of Care |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| 30 Days |
| Secondary Endpoint 3- Change in Kidney Function. | Change in kidney function by analyzing eGFR 3 to 5 days post procedure. | 3-5 days |
| Long Beach |
| California |
| 90812 |
| United States |
| Kaiser Permanente Los Angeles Medical Center | Los Angeles | California | 90027 | United States |
| Stanford Hospital and Clinics | Stanford | California | 94305-5218 | United States |
| Harbor UCLA Medical Center | Torrance | California | 90509 | United States |
| The Heart & Vascular Institute of Florida | Clearwater | Florida | 33756 | United States |
| University of FL College of Medicine - Jacksonville | Jacksonville | Florida | 32209 | United States |
| St. Vincent's Ambulatory Care (dba St. Vincent's Cardiology) | Jacksonville | Florida | 32216 | United States |
| Tallahassee Research Institute, Inc. | Tallahassee | Florida | 32308 | United States |
| Emory University Hospital Midtown | Atlanta | Georgia | 30308 | United States |
| St. Joseph's Hospital (Emory) | Atlanta | Georgia | 30342 | United States |
| Coliseum Medical Center | Macon | Georgia | 31217 | United States |
| University of Illinois at Chicago | Chicago | Illinois | 60612 | United States |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| Jewish Hospital | Louisville | Kentucky | 40202 | United States |
| Norton Cardiovascular Associates | Louisville | Kentucky | 40205 | United States |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | United States |
| Minneapolis Heart Institute Foundation / Abbott Northwestern Hospital | Minneapolis | Minnesota | 55407 | United States |
| Mayo Clinic Hospital, St. Mary's Campus | Rochester | Minnesota | 55902 | United States |
| North Mississippi Medical Center | Tupelo | Mississippi | 38801 | United States |
| Saint Luke's Hospital | Kansas City | Missouri | 64111 | United States |
| Gateway Cardiovascular Research Center, Inc. | St Louis | Missouri | 63128 | United States |
| Mount Sinai Hospital | New York | New York | 10029 | United States |
| LeBauer Cardiovascular Research Foundation | Greensboro | North Carolina | 27401 | United States |
| NC Heart and Vascular Research | Raleigh | North Carolina | 27610 | United States |
| Oklahoma Heart | Oklahoma City | Oklahoma | 73120 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| York Hospital | York | Pennsylvania | 17405 | United States |
| Providence Cardiology LLC | Columbia | South Carolina | 29204 | United States |
| Baptist Memorial Hospital | Memphis | Tennessee | 38120 | United States |
| VA North Texas Health Care System | Dallas | Texas | 75216 | United States |
| CHI St. Luke's Health / Baylor St. Luke's Medical Center | Houston | Texas | 77030 | United States |
| Houston Methodist Hospital | Houston | Texas | 77030 | United States |
| The Heart Hospital Baylor Plano | Plano | Texas | 75093 | United States |
| U of TX Health Science Center San Antonio (UTHSCSA) | San Antonio | Texas | 78229-3900 | United States |
| Trinity Mother Frances/Cardiovascular Associates of East Texas PA | Tyler | Texas | 75701 | United States |
| Sentara Cardiovascular Research Institute / Norfolk General | Norfolk | Virginia | 23507 | United States |
| Heart Center Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
| Auckland City Hospital | Auckland | 1023 | New Zealand |
|
| Completed Procedure |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Treatment | Standard of Care with the AVERT system AVERT |
| BG001 | Standard of Care | |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Gender | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Primary Effectiveness Endpoint | Reduction in the incidence of Contrast Induced Nephropathy (CIN) by evaluating Serum Creatinine levels in subjects for up to 5 days. | Only subjects that completed blood draws were analyzed for this outcome. | Posted | Count of Participants | Participants | 3-5 days |
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| Primary | Primary Safety Endpoint- Number of Participants Experiencing a Device Related Serious Adverse Event | Analyze the incidence of device related serious adverse events within the treatment arm. | Posted | Count of Participants | Participants | 30 days |
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| Secondary | Secondary Endpoint 1- | Comparison in contrast media volume required between active treament and standard of care. | Reduction in volume of contrast was analysed in an interim analysis once half the patient population was enrolled. Additionally, only subjects that completed the procedure were analyzed for this endpoint. | Posted | Mean | Standard Deviation | Contrast Volume (ml) | 30 Days |
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| Secondary | Secondary Endpoint 2- Comparison of Serious Adverse Events. | Comparing event rates of serious adverse events 30 days following the index procedure. | Posted | Number | events | 30 Days |
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| Secondary | Secondary Endpoint 3- Change in Kidney Function. | Change in kidney function by analyzing eGFR 3 to 5 days post procedure. | Posted | Mean | Standard Deviation | mL/min/1.73m² | 3-5 days |
|
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30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Treatment | Standard of Care with the AVERT system AVERT | 36 | 292 | 0 | 292 | ||
| EG001 | Standard of Care | 38 | 286 | 0 | 286 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial Infarction | Cardiac disorders |
| |||
| Dialysis dependent CIN | Renal and urinary disorders |
| |||
| Unplanned re-hospitalization | General disorders |
| |||
| Major bleeding | Surgical and medical procedures |
| |||
| Stroke | Cardiac disorders |
| |||
| All-Cause Mortality | General disorders |
| |||
| Revascularization of target lesion | Cardiac disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michele Shepard, Vice President of Clinical Affairs | Osprey Medical, Inc | 9529558236 | mshepard@ospreymed.com |
| Male |
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