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The objective of this feasibility study is to demonstrate that the device is safe and potentially efficacious for use in patients undergoing high risk Percutaneous Coronary Interventions(PCI).Patients will be enrolled if they meet inclusion & exclusion criteria.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Risk PCI | Device | High Risk Percutaneous Coronary Intervention |
| Measure | Description | Time Frame |
|---|---|---|
| MACCE Events at 30 days or discharge, whichever is longer | Major Adverse Cardiac and Cerebral (MACCE) events defined as death, new myocardial infarction, target vessel revascularization, urgent coronary artery bypass grafting procedure or cerebral vascular accident during and up to 30 days post-device explant or hospital discharge, whichever is longer. | 30 days or discharge |
| Freedom from Hemodynamic compromise during PCI procedure | Freedom from Hemodynamic compromise during PCI procedure defined as: Mean Arterial Pressure (MAP) not falling below 60mm Hg for more than 10 minutes during the PCI procedure and additional pressor medication is not required | During procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Other intra-procedural and peri-procedural adverse events | During treatment and out to 90 days | |
| Freedom from Ventricular fibrillation and Tachycardia requiring electrical cardioversion | Freedom from the following procedural-related events: i. Ventricular fibrillation ii. Tachycardia requiring electrical cardioversion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William O'Neill, M.D. | Not affiliated with Abiomed | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps | La Jolla | California | 92037 | United States | ||
| Cedars-Sinai Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19463408 | Derived | Dixon SR, Henriques JP, Mauri L, Sjauw K, Civitello A, Kar B, Loyalka P, Resnic FS, Teirstein P, Makkar R, Palacios IF, Collins M, Moses J, Benali K, O'Neill WW. A prospective feasibility trial investigating the use of the Impella 2.5 system in patients undergoing high-risk percutaneous coronary intervention (The PROTECT I Trial): initial U.S. experience. JACC Cardiovasc Interv. 2009 Feb;2(2):91-6. doi: 10.1016/j.jcin.2008.11.005. |
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| During procedure |
| Angiographic Success | Angiographic success defined as residual stenosis <30% after stent implantation or <50% after balloon angioplasty. | Post-PCI |
| Los Angeles |
| California |
| 90048 |
| United States |
| Mass General Hospital | Boston | Massachusetts | 02114 | United States |
| Brigham & Womens | Boston | Massachusetts | 02115 | United States |
| William Beaumont | Royal Oak | Michigan | 48073 | 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 |
| UPMC Presbyterian Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
| Texas Heart | Houston | Texas | 777030 | United States |
| Academic Medical Center | Amsterdam | Netherland | Netherlands |