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Futility on primary endpoint.Study confounded by statistically significant differences between the two arms re: atherectomy, duration of support.
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The IMPELLA® 2.5 System will be superior to Intra Aortic Balloon Pump in preventing the composite rate of major adverse events during and after the PCI procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMPELLA LP 2.5 | Experimental |
| |
| IABP Intra-aortic balloon pump | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMPLELLA LP 2.5 | Device | Insertion of the LP 2.5 IMPELLA circulatory support system that can be placed across the aortic valve using a single femoral site. The device pumps blood from the left ventricle into the ascending aorta at 2.5 L/min. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite rate of 10 major adverse events including death; MI;Stroke or TIA; and repeat revascularization. | 30 days +/- 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum CPO decrease from baseline.Rate of in hospital major events compared between the IMPELLA and IABP. | In hospital events |
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Inclusion Criteria:
Informed consent
Subject is indicated for a NON emergent percutaneous treatment of at least on de novo or restenotic lesion in a native coronary vessel or bypass graft.
Patient presents with:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William O'Neill | Not affilicated with Abiomed | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35294 | United States | ||
| Mercy Gilbert Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26542494 | Derived | Cohen MG, Matthews R, Maini B, Dixon S, Vetrovec G, Wohns D, Palacios I, Popma J, Ohman EM, Schreiber T, O'Neill WW. Percutaneous left ventricular assist device for high-risk percutaneous coronary interventions: Real-world versus clinical trial experience. Am Heart J. 2015 Nov;170(5):872-9. doi: 10.1016/j.ahj.2015.08.009. Epub 2015 Aug 15. | |
| 26385039 |
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| IABP Intra-aortic balloon pump | Device | IABP uses counterpulsation to provide 0.2L/min coronary flow |
|
| Gilbert |
| Arizona |
| 85297 |
| United States |
| Banner Good Samaritan Medical Center | Phoenix | Arizona | 85006 | United States |
| California Cardiovascular/Washington Hospital | Fremont | California | 94538 | United States |
| Foundation for Cardiovascular Medicine | La Jolla | California | 92037 | United States |
| University of Southern California | Los Angeles | California | 90033 | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| Munroe Regional Medical Center | Ocala | Florida | 34471 | United States |
| Emory Crawford Long Hospital | Atlanta | Georgia | 30308 | United States |
| Medical College Of Georgia | Augusta | Georgia | 30912 | United States |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| Washington Adventist Hospital | Takoma Park | Maryland | 20912 | United States |
| Massach General Hospital | Boston | Massachusetts | 02114 | United States |
| Brigham & Womens | Boston | Massachusetts | 02115 | United States |
| St. Elizabeths Medical Center | Boston | Massachusetts | 02135 | United States |
| Oakwood Hospital Wayne State University | Dearborn | Michigan | 48124 | United States |
| Henry Ford Medical | Detroit | Michigan | 35294 | United States |
| Harper Hospital | Detroit | Michigan | 48201 | United States |
| St. John Hospital and Medical Center | Detroit | Michigan | 48236 | United States |
| Northern Michigan | Petoskey | Michigan | 49770 | United States |
| William Beaumont | Royal Oak | Michigan | 48073 | United States |
| Providence Hospital and Medical Centers | Southfield | Michigan | 48075 | United States |
| St. Louis University | St Louis | Missouri | 63110 | United States |
| Bryan LGH Heart Institute | Lincoln | Nebraska | 68506 | United States |
| Morristown Memorial | Morristown | New Jersey | 07962 | United States |
| Mt. Sinai School of Medicine | New York | New York | 10029-6574 | United States |
| Columbia Presbyterian Hospital | New York | New York | 10032 | United States |
| Strong Memorial Hospital | Rochester | New York | 14642 | United States |
| Carolinas Medical Center | Charlotte | North Carolina | 28203 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Cardiovascular Research of Forsythe Medical | Winston-Salem | North Carolina | 27103 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45267 | United States |
| Riverside Methodist | Columbus | Ohio | 43214 | United States |
| UPMC Presbyterian Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
| Robert Packer Hospital | Sayre | Pennsylvania | 18840 | United States |
| Pinnacle Health | Wormleysburg | Pennsylvania | 17043 | United States |
| York Hospital | York | Pennsylvania | 17403 | United States |
| Veteran's Affairs Medical Center Dallas | Dallas | Texas | 75216 | United States |
| Methodist Hospital | Houston | Texas | 77030 | United States |
| University of Texas Medical School at Houston | Houston | Texas | 77030 | United States |
| Intermountain Medical Center | Murray | Utah | 84157 | United States |
| St. Joseph's Hospital | Bellingham | Washington | 98225 | United States |
| University of Washington | Seattle | Washington | 98198 | United States |
| Royal Alexandra Hospital | Edmonton | Alberta | T5H3V9 | Canada |
| University of Alberta Hospital | Edmonton | Alberta | T6G2B7 | Canada |
| Ottawa Heart Institute | Ottawa | Ontario | K1Y4W7 | Canada |
| Toronto General Hospital | Toronto | Ontario | M5G1Z5 | Canada |
| Royal Victoria Hospital at McGill | Montreal | Quebec | H3A1A1 | Canada |
| Academic Medical Center | Amsterdam | Netherlands | Netherlands |
| Daubert MA, Massaro J, Liao L, Pershad A, Mulukutla S, Magnus Ohman E, Popma J, O'Neill WW, Douglas PS. High-risk percutaneous coronary intervention is associated with reverse left ventricular remodeling and improved outcomes in patients with coronary artery disease and reduced ejection fraction. Am Heart J. 2015 Sep;170(3):550-8. doi: 10.1016/j.ahj.2015.06.013. Epub 2015 Jun 26. |
| 25689546 | Derived | Kovacic JC, Kini A, Banerjee S, Dangas G, Massaro J, Mehran R, Popma J, O'Neill WW, Sharma SK. Patients with 3-vessel coronary artery disease and impaired ventricular function undergoing PCI with Impella 2.5 hemodynamic support have improved 90-day outcomes compared to intra-aortic balloon pump: a sub-study of the PROTECT II trial. J Interv Cardiol. 2015 Feb;28(1):32-40. doi: 10.1111/joic.12166. |
| 24655695 | Derived | Henriques JP, Ouweneel DM, Naidu SS, Palacios IF, Popma J, Ohman EM, O'Neill WW. Evaluating the learning curve in the prospective Randomized Clinical Trial of hemodynamic support with Impella 2.5 versus Intra-Aortic Balloon Pump in patients undergoing high-risk percutaneous coronary intervention: a prespecified subanalysis of the PROTECT II study. Am Heart J. 2014 Apr;167(4):472-479.e5. doi: 10.1016/j.ahj.2013.12.018. Epub 2014 Jan 3. |
| 24527505 | Derived | Dangas GD, Kini AS, Sharma SK, Henriques JP, Claessen BE, Dixon SR, Massaro JM, Palacios I, Popma JJ, Ohman M, Stone GW, O'Neill WW. Impact of hemodynamic support with Impella 2.5 versus intra-aortic balloon pump on prognostically important clinical outcomes in patients undergoing high-risk percutaneous coronary intervention (from the PROTECT II randomized trial). Am J Cardiol. 2014 Jan 15;113(2):222-8. doi: 10.1016/j.amjcard.2013.09.008. |
| 22935569 | Derived | O'Neill WW, Kleiman NS, Moses J, Henriques JP, Dixon S, Massaro J, Palacios I, Maini B, Mulukutla S, Dzavik V, Popma J, Douglas PS, Ohman M. A prospective, randomized clinical trial of hemodynamic support with Impella 2.5 versus intra-aortic balloon pump in patients undergoing high-risk percutaneous coronary intervention: the PROTECT II study. Circulation. 2012 Oct 2;126(14):1717-27. doi: 10.1161/CIRCULATIONAHA.112.098194. Epub 2012 Aug 30. |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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