|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P990036 / PAS001 |
| Date Original Protocol Accepted |
11/03/2000
|
| Date Current Protocol Accepted |
|
| Study Name |
PAS
|
| Device Name |
CORDIS CHECKMATE(TM) SYSTEM
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
GAMMA V was a prospective, multicenter, non-randomized trial. Patients entering the trial may or may not have had new stents implanted at operator discretion. Patients either received new stent placement, intravascular radiation therapy and 12 months of antiplatelet therapy or no new stent placement and 6 months of dual antiplatelet therapy.
|
| Study Population |
Patients with de novo coronary artery lesions in vessels 2.75 - 4.0 mm in diameter and for lesions up to and including 45 mm in length.
|
| Sample Size |
600 patients
|
| Key Study Endpoints |
The primary enpoints included 1) Target Lesion Revascularization, 2) Target vessel revascularization, 3) Major Cardiac Adverse events, defined as death, myocardial infarction (Q-wave and non-Q-wave), emergent bypass surgery or TLR, 4) Canadian Cardiovascular Society Assessment Classification (class I (ordinary activity)-class IV (inability to carry out any physical activity)), 5) Late Thrombosis: myocardial infarction attributable to the target vessel with angiographic documentation of thrombus or total occlusion at the target site > 30 days after the index procedure in the absence of an intervening revascularization of the target vessel, 6) Repeat hospitalization), and 7) Outpatient diagnostic testing.
|
| Follow-up Visits and Length of Follow-up |
The study was originally planned for three years, but extended to five years to meet the conditions of approval. The protocol called for follow-up visits at 1, 3, 6, 9, 12, 15, 24, 36, 48 and 60 months. Follow-up included clinic visits, angiographic studies and telephone contact.
|
| Interim or Final Data Summary |
| Interim Results |
Study completed, see final results.
|
| Actual Number of Patients Enrolled |
579 patients
|
| Actual Number of Sites Enrolled |
38 sites
|
| Patient Follow-up Rate |
There were 76 patients who did not consent to the extended follow-up (years 4 and 5). Thirty seven (37) of the patients who refused to participate in the study follow-up provided follow-up safety information.
|
| Final Safety Findings |
The final effectiveness results were: 43.1% of patients with new stents were free of target lesion revascularization at 1800 days and 56.2% of patients without new stents were free of target lesions revascularization at 1800 days. The final safety results were: the late thrombosis rate for newly stented patients was 3.1% and 2.8% for non-stented patients and major adverse cardiac events, emergent bypass surgery or target lesion revascularization was 62.7% for stented patients and 55.1% for non-stented patients.
|
| Study Strengths & Weaknesses |
Strength: This study provided data on stented and non-stented patients with the Cordis Checkmate System, however the 5 year follow-up was only available for 465 out of 579 patients (80%).
|
| Recommendations for Labeling Changes |
None
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