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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P030047 / PAS001 |
| Date Original Protocol Accepted |
09/22/2006
|
| Date Current Protocol Accepted |
09/22/2006
|
| Study Name |
Longterm & CASES Studies
|
| Device Name |
CORDIS PRECISE NITINOL STENT SYSTEM
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
Concurrent Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
This study was a multi-center, prospective, single arm, open-label study to assess safety and efficacy outcomes of stenting with distal protection in the treatment of obstructive carotid artery disease during peri-approval/initial commercialization phase of Cordis' carotid program in relation to the outcomes of the SAPPHIRE clinical trial.
|
| Study Population |
This device is indicated for use in conjunction with the ANGIOGUARD XP Emboli Capture Guidewire for the treatment of patients at high risk for adverse events from carotid endarterectomy (defined in the IFU) who require carotid revascularization and meet the criteria outlined: 1) Patients with neurological symptoms and >50% stenosis of the common or internal carotid artery by ultrasound or angiogram OR patients without neurological symptoms and >80% stenosis of the common or internal carotid artery by ultrasound or angiogram, AND 2) Patients must have a vessel diameter of 4-9mm at the target lesion. The vessel distal to the target lesion must be within the range of 3mm and 7.5mm to allow for placement of the ANGIOGUARD XP Emboli Capture Guidewire. The study population was designed to be comprised of up to 1500 patients with de novo atherosclerotic or post-endarterectomy restenotic obstructive lesions in native carotid arteries.
|
| Sample Size |
1500 patients, 112 sites
|
| Key Study Endpoints |
This study was a non-inferiority trial designed to test the primary endpoint, major adverse events at 30 days, against an established performance criteria (9.3%).
|
| Follow-up Visits and Length of Follow-up |
Clinical follow-up was conducted at 30 days and conducted via telephone contact at 1-year post-procedure. The assessment at 30 days included a neurological examination and an evaluation of any adverse events. At 1-year post-procedure an evaluation of any adverse events was performed.
|
| Interim or Final Data Summary |
| Interim Results |
Study completed, see final results.
|
| Actual Number of Patients Enrolled |
1472 patients
|
| Actual Number of Sites Enrolled |
80 sites
|
| Patient Follow-up Rate |
84%
|
| Final Safety Findings |
The rate of the primary endpoint, major adverse events, at 30 days post-procedure is 5.0% (74/1492) with a 95% confidence interval (CI) 3.9%, 6.2%. The rate of major adverse events at 360 days post-procedure is 11.6% (173/1492) with 95% CI [10.0%, 13.3%] for all intent-to-treat patients. The 30 day rate of 5.0% is below the SAPPHIRE rate of 6.3% and the OPC rate of 9.3%.
|
| Study Strengths & Weaknesses |
Strengths: The sponsor utilized the peri-approval approach to rapidly start up this study. Weaknesses: The sponsor does not provide a context within which to interpret the 360 day rate, therefore it is difficult to assess whether the device is safe at 360 days post-implant.
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| Recommendations for Labeling Changes |
Updated labeling requested from sponsor to reflect 30 day major adverse event rates.
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