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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P160049 / PAS001 |
| Date Original Protocol Accepted |
07/26/2017
|
| Date Current Protocol Accepted |
|
| Study Name |
ILLUMINATE Continued Follow-Up Study
|
| Device Name |
STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON
|
| Clinical Trial Number(s) |
NCT01858428
|
| General Study Protocol Parameters |
| Study Design |
Randomized Clinical Trial
|
| Data Source |
New Data Collection
|
| Comparison Group |
Concurrent Control
|
| Analysis Type |
Analytical
|
| Study Population |
Adult: At least 22 yrs
|
| Detailed Study Protocol Parameters |
| Study Objectives |
This study will evaluate the long-term safety and effectiveness of the Stellarex 035 DCB in 300 subjects from the premarket study (ILLUMINATE trial).
|
| Study Population |
The test group is the Stellarex DCB and the control group is standard PTA.
|
| Sample Size |
A minimum of 236 subjects evaluable at 24 months are required for the sample size calculations.
|
| Key Study Endpoints |
The primary effectiveness endpoint is primary patency of the target lesion at 24 months. The primary safety endpoint is a composite of freedom from device- and procedure-related death at 30 days and freedom from target limb major amputation and clinically-driven target vessel revascularization (CD-TVR) at 24 months. Secondary endpoints include : (1) major adverse events (MAE), (2) clinically-driven target lesion revascularization (CD-TLR), (3) all TLR, (4) clinically-driven target vessel revascularization (CD-TVR), (5) target limb major amputation, (6) mortality, and (7) arterial thrombosis. The endpoints to be assessed at 2 and 3 years post-procedure are: (1) patency, (2) change in ankle-brachial index (ABI), (3) change in walking impairment questionnaire (WIQ), (4) change in walking distance, (5) change in Rutherford-Becker classification, and (6) change in quality of life assessment by EQ-5D questionnaire.
|
| Follow-up Visits and Length of Follow-up |
5 years
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
300
|
| Actual Number of Sites Enrolled |
43
|
| Patient Follow-up Rate |
86.3% at 5 years
|
| Final Safety Findings |
Major adverse events, as well as all-cause mortality were similar between treatment
arms through 5 years.
|
| Final Effect Findings |
Primary patency was assessed through 3 years, showing similar outcomes at this point.
Similar outcomes were also demonstrated for clinically-driven target lesion
revascularization through 5 years.
|
| Study Strengths & Weaknesses |
Strengths: The study was a prospectively designed randomized controlled trial with
appropriate oversight.
Weakness: A higher rate of missing data was present for 5 year follow up.
|
| Recommendations for Labeling Changes |
Labeling should be updated to include 5 year clinical data
|
