|
General |
Study Status |
Completed |
Application Number / Requirement Number |
P950015 / PAS001 |
Date Original Protocol Accepted |
08/20/1998
|
Date Current Protocol Accepted |
 
|
Study Name |
Heart Laser CO2
|
Device Name |
THE HEART LASER TM CO2 LASER SYSTEM FOR TRANSMYOCARDIAL REVASCULARIZATION
|
General Study Protocol Parameters |
Study Design |
Prospective Cohort Study
|
Data Source |
External Registry
|
Comparison Group |
Historical Control
|
Analysis Type |
Analytical
|
Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
Detailed Study Protocol Parameters |
Study Objectives |
This is a two-armed prospective cohort, multi-stite registry study. The registry was randomly divided between those who received TMR at the time of enrollment and those whose TMR was delayed for 30 days.
|
Study Population |
The study population was patients for whom the Chilli device is indicated, who had failed or were intolerant to drug therapy. The device is approved for the treatment of refractory class 3-4 angina secondary to objectively demonstrated coronary artery atherosclerosis not amenable to standard therapies such as CABG or PTCA.
|
Sample Size |
600 patients. 39 sites. Patients to be randomly divided between those who received TMR at the time of enrollment and those who were delayed 30 days prior to treatment.
|
Key Study Endpoints |
The primary endpoint was 30-day and one-year mortality. The secondary endpoint was adverse events.
|
Follow-up Visits and Length of Follow-up |
The primary endpoints were evaluated at 30 days and one year.
|
Interim or Final Data Summary |
Interim Results |
Study completed, see final results.
|
Actual Number of Patients Enrolled |
516 patients
|
Actual Number of Sites Enrolled |
39 sites
|
Patient Follow-up Rate |
92%
|
Final Safety Findings |
There was a high one month mortality rate were compared to the pre-market study.
|
Study Strengths & Weaknesses |
Weaknesses: The data that was internally inconsistent and there was no comparison of the primary endpoint with a meaningful control group.
|
Recommendations for Labeling Changes |
None
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