The PEARL 8.0 Post-Approval Study
NCT01845103 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 1
Last updated 2016-10-06
Summary
This is a prospective single arm study of the Cardiogenesis PEARL 8.0 Handpiece Delivery System. The purpose of this study is to demonstrate that the 30 day mortality rate among patients who are treated with this device is less than the historical rate plus a non-inferiority margin.
Conditions
- Class IV Angina
Sponsors & Collaborators
-
Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc.
lead INDUSTRY
Principal Investigators
-
Scott B Capps, MS · CryoLife, Inc.
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-09-30
- Primary Completion
- 2014-12-31
- Completion
- 2014-12-31
Countries
- United States
Study Locations
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