Status:
COMPLETED
Cardiogenesis Transmyocardial Revascularization Registry
Lead Sponsor:
Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc.
Conditions:
Class IV Angina
Eligibility:
All Genders
18+ years
Brief Summary
The objectives of the registry are as follows: * Track "real world" performance outcomes and physician experience using the Cardiogenesis Laser System; * Further define the disease characteristics of...
Detailed Description
The objectives of this patient registry, which collects data on the Cardiogenesis Laser System, include: provide further information on the disease characteristics of the population being treated, exa...
Eligibility Criteria
Inclusion
- Class IV angina (according to Canadian Cardiovascular Society Angina Scale)
- Patients with regions of myocardium in the distal two-thirds of the left ventricle with reversible ischemia and who are not eligible for direct coronary revascularization (e.g., CABG or PTCA)
Exclusion
- Age less than18 years
- Severely unstable angina (un-weanable from intravenous anti-anginals for 48-hours)
Key Trial Info
Start Date :
May 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
203 Patients enrolled
Trial Details
Trial ID
NCT01827319
Start Date
May 1 2013
End Date
June 1 2015
Last Update
August 15 2016
Active Locations (24)
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1
University of Arizona
Tuscon, Arizona, United States, 85722
2
California Cardiac Surgeons
Bakersfield, California, United States, 93301
3
The Vo Group
Fountain Valley, California, United States, 92708
4
Hurwitz & Roberts Med Corp
Glendale, California, United States, 91204