|
|
| General |
| Study Status |
Completed |
| 522 Number / Requirement Number |
PS060003 / PSS001 |
| Date Original Plan Accepted |
05/22/2007
|
| Date Current Plan Accepted |
05/22/2007
|
| Study Name |
Graft Patency and Technical Failure
|
| Device Name |
C-port distal anastomosis system
|
| Root Document Number |
K040832
K053524
K063644
K070548
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Sponsor 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 |
A prospective, multi-center, registry will be used to obtain data for the currently manufactured C-Port devices. The one-year graft occlusion rate for the C-Port device will be compared with an a priori rate taken from the published results of the PREVENT IV trial, which is 26.63% (597/2,242).
|
| Study Population |
Subjects who meet indication criteria for device
|
| Sample Size |
100 patients, 8 sites
|
| Key Study Endpoints |
Primary: Failure of the anastomoses of the index grafts assessed in subjects by Gated 64-slice CT scan at 12-months following surgery. Secondary: Technical failure rates for anastomoses produced with the C-Port device. Technical success rate of hand-sewn anastomoses following technical failures with the C-Port device, as well as technical failure rate and clinical sequelae of the hand-sewn anastomoses at one year. Retrospective evaluation to establish the types of technical failures and adverse events associated with the original C-Port device, by reviewing available postmarket feedback data.
|
| Follow-up Visits and Length of Follow-up |
Length of f/u 1 year
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
117 = 100%
|
| Actual Number of Sites Enrolled |
10 = 100%
|
| Patient Followup Rate |
91 = 78%
|
| Final Safety Findings |
4. Final safety findings (key endpoints) None of significant concern. The safety
profile compared favorably to the PREVENT IV control group, with a one year mortality rate of 0.8% and a major cardiac adverse event rate of 4.3%.
Technical failure rate: 1.6%
There were 4 cases converted to hand-sewn anastomoses, and of those, there was one adverse event – graft occlusion.
|
| Final Effectiveness Findings |
15.4% occlusion rate of C-Port anastomoses at one year, with an upper confidence limit of 21.3%. That compares favorably with the performance goal of 26.6%
|
| Study Strengths and Weaknesses |
Strengths:
o Prospective cohort study
o Performance goal for primary endpoint met by a wide margin
o Follow-up rate of only 78% (However, sponsor provided good evidence that bias due to that fact was unlikely to have significantly affected the final results, especially considering the wide margin by which the study success criteria was met
o Absence of a concurrent control group (study used a performance goal based on historical data instead)
|
| Recommendations for Labeling Changes |
None
|
