Trials / Unknown
UnknownNCT02831881
Protected PCI Study
PROTECTED PCI STUDY: A Prospective Clinical Trial For Patients Undergoing Protected Percutaneous Coronary Intervention With IMPELLA® 2.5 System
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 369 (estimated)
- Sponsor
- Abiomed Inc. · Industry
- Sex
- All
- Age
- 18 Years – 90 Years
- Healthy volunteers
- Not accepted
Summary
A Prospective, multi-center, single-arm post-approval study of the IMPELLA® 2.5 System in Non Emergent High Risk PCI patients.
Detailed description
The objective of the study is to assess the safety and efficacy of the IMPELLA® 2.5 System in subjects undergoing non-emergent high-risk percutaneous coronary intervention (PCI) post market approval. The primary endpoint will be a composite clinical endpoint of major adverse events through 90 days following the PCI procedure. The outcome will be compared to the pre specified performance goal of 53%.
Conditions
Timeline
- Start date
- 2015-11-01
- Primary completion
- 2020-11-01
- First posted
- 2016-07-13
- Last updated
- 2016-07-13
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02831881. Inclusion in this directory is not an endorsement.