Patients Undergoing High Risk PCI. Clinical Trial
— PROTECT IOfficial title:
PROTECT I, A Prospective Feasibility Trial Investigating the Use of the IMPELLA RECOVER LP 2.5 System in Patients Undergoing High Risk PCI
| Verified date | March 2011 |
| Source | Abiomed Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 28 |
| Est. completion date | March 2011 |
| Est. primary completion date | June 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 40 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - Signed Informed Consent - Non emergent PCI of at least one de novo or restenotic lesion in a native coronary vessel or bypass graft - EF <35% Exclusion Criteria: - ST Myocardial Infarction - Cardiac Arrest - Cardiogenic Shock - Thrombus Left Ventricle |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | Academic Medical Center | Amsterdam | Netherland |
| United States | Brigham & Womens | Boston | Massachusetts |
| United States | Mass General Hospital | Boston | Massachusetts |
| United States | Texas Heart | Houston | Texas |
| United States | Scripps | La Jolla | California |
| United States | Cedars-Sinai Medical Center | Los Angeles | California |
| United States | Mt. Sinai School of Medicine | New York | New York |
| United States | Columbia Presbyterian Hospital | New York, | New York |
| United States | UPMC Presbyterian Hospital | Pittsburgh | Pennsylvania |
| United States | William Beaumont | Royal Oak | Michigan |
| Lead Sponsor | Collaborator |
|---|---|
| Abiomed Inc. |
United States, Netherlands,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Yes |
| Primary | 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 | Yes |
| Secondary | Other intra-procedural and peri-procedural adverse events | During treatment and out to 90 days | Yes | |
| Secondary | Freedom from Ventricular fibrillation and Tachycardia requiring electrical cardioversion | Freedom from the following procedural-related events: i. Ventricular fibrillation ii. Tachycardia requiring electrical cardioversion |
During procedure | Yes |
| Secondary | Angiographic Success | Angiographic success defined as residual stenosis <30% after stent implantation or <50% after balloon angioplasty. | Post-PCI | Yes |