Trials / Completed
CompletedNCT00534859
PROTECT I, A Prospective Feasibility Trial Investigating the Use of IMPELLA RECOVER LP 2.5 System in Patients Undergoing High Risk PCI
PROTECT I, A Prospective Feasibility Trial Investigating the Use of the IMPELLA RECOVER LP 2.5 System in Patients Undergoing High Risk PCI
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 28 (actual)
- Sponsor
- Abiomed Inc. · Industry
- Sex
- All
- Age
- 40 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | High Risk PCI | High Risk Percutaneous Coronary Intervention |
Timeline
- Start date
- 2006-08-01
- Primary completion
- 2010-06-01
- Completion
- 2011-03-01
- First posted
- 2007-09-26
- Last updated
- 2011-03-21
Locations
10 sites across 2 countries: United States, Netherlands
Source: ClinicalTrials.gov record NCT00534859. Inclusion in this directory is not an endorsement.