|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P030025 S028/ PAS001 |
| Date Original Protocol Accepted |
09/24/2008
|
| Date Current Protocol Accepted |
09/24/2008
|
| Study Name |
5 year Clinical Outcomes
|
| Device Name |
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER -THE-WIRE)
|
| 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 yrs < 22 yrs,
Adult: At least 22 yrs
|
| Detailed Study Protocol Parameters |
| Study Objectives |
This is a prospective, randomized, controlled, multicenter, double-blind safety and efficacy study. Patients were randomized in a 1:1 ratio to receive either the TAXUS Express Slow-Release paclitaxel-eluting stent system or an uncoated Express control stent. Randomization included stratification by clinical site, target lesion length (<18 mm versus >18 mm), and the presence or absence of medically treated diabetes mellitus. The primary objective of this study was to further evaluate the safety and effectiveness of the TAXUS Express Paclitaxel-Eluting Coronary Stent System in long lesion lengths, small and large vessel diameters and with multiple overlapping stents in the treatment of de novo coronary artery lesions.
|
| Study Population |
The device is indicated for improving luminal diameter for the treatment of de novo lesions in native coronary arteries >=2. 25 to <=4. 00 mm in diameter in lesions <=28 mm in length, and within bare metal stent restenotic lesions >=2. 25 to <=3. 75 mm in diameter and <=28 mm in length.
|
| Sample Size |
1172 patients (86 in the TAXUS group and 586 in the Control group), 66 sites
|
| Key Study Endpoints |
The primary endpoint is the rate of ischemia-driven target vessel revascularization at 9 months after the index procedure. The 5 year safety data will be reported for 1) Major Adverse Cardiac Events, 2) Myocardial infarction (Q-wave and non-Q-wave), 3) All-cause death and cardiac death, 4) Serious adverse events, and 5) Stent thrombosis.
|
| Follow-up Visits and Length of Follow-up |
Patients will be follow for 5 years post procedure. A subset of patients will have a follow-up intravascular ultrasound at the 9-month follow-up evaluation.
|
| Interim or Final Data Summary |
| Interim Results |
The major cardiac eventrate at 4 years was significantly lower for TAXUS compared to Brachy (28.4% versus 41.6%; P=0.0054), a relative reduction of 31.7%. The decrease in the major cardiac event rate was largely driven by a significant reduction in target vessel revascularization in TAXUS patients (23.8%), as compared to Brachy patients (39.3%). Myocardial infarction rates through 4 years were comparable between the TAXUS (5.2%) and Brachy groups (9.3%). Cardiac death rates through 4 years were comparable between TAXUS (4.5%) and Brachy (3.4%).
|
| Actual Number of Patients Enrolled |
421
|
| Actual Number of Sites Enrolled |
37
|
| Patient Follow-up Rate |
86.3%
|
| Final Safety Findings |
Through 5 years of follow-up, the safety profile of the TAXUS group demonstrated better MACE outcomes compared to Brachytherapy. The MACE benefit observed for TAXUS at 1 year persisted through 5 years and was driven predominantly by a significantly lower TVR rate. There were no significant differences in the individual rates of cardiac death, MI, and target vessel thrombosis between the TAXUS and Brachytherapy groups at 5 years. The rate of stent thrombosis remained low in the TAXUS group with no new events after 4 years.
|
| Final Effect Findings |
Between 4 and 5 years, the rates of TVR (6.7% Brachytherapy, 5.5% TAXUS; P=0.6267) and TLR (5.5% Brachytherapy, 4.4% TAXUS; P=0.6296) were similar between treatment groups
|
| Study Strengths & Weaknesses |
Sponsor demonstrated adequate follow-up out to 5 years. The results do not raise any safety concerns. The strength of the clinical evidence of the TAXUS V-ISR results is enhanced by the RCT design and relatively large sample size (421 patients with ISR from 37 centers).
|
| Recommendations for Labeling Changes |
Updated labeling to include ISR 5 year study results.
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P030025 S028/ PAS002 |
| Date Original Protocol Accepted |
09/24/2008
|
| Date Current Protocol Accepted |
09/24/2008
|
| Study Name |
Fatigue/Matter Testing
|
| Device Name |
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER -THE-WIRE)
|
| General Study Protocol Parameters |
| Study Design |
Bench/Lab Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Transit.Adolescent B(as adults): 18 yrs < 22 yrs,
Adult: At least 22 yrs
|
| Detailed Study Protocol Parameters |
| Study Objectives |
This is a simulated use particulates testing, 10-year equivalent pulsatile particulates on a curve testing, 10-year equivalent pulsatile fatigue on a curve testing.
|
| Study Population |
N/A
|
| Sample Size |
N/A
|
| Key Study Endpoints |
This is a simulated use particulates testing, 10-year equivalent pulsatile particulates on a curve testing, 10-year equivalent pulsatile fatigue on a curve testing.
|
| Follow-up Visits and Length of Follow-up |
N/A
|
| Interim or Final Data Summary |
| Interim Results |
N/A, This is a bench testing study.
|
| Actual Number of Patients Enrolled |
NA
|
| Actual Number of Sites Enrolled |
NA
|
| Patient Follow-up Rate |
NA
|
| Final Safety Findings |
NA
|
| Final Effect Findings |
NA
|
| Study Strengths & Weaknesses |
NA
|
| Recommendations for Labeling Changes |
None
|
