|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P190019 / PAS001 |
| Date Original Protocol Accepted |
12/16/2020
|
| Date Current Protocol Accepted |
|
| Study Name |
RANGER II SFA Cont F/u Study
|
| Device Name |
Ranger™ Paclitaxel-Coated PTA Balloon Catheter
|
| Clinical Trial Number(s) |
NCT03064126
|
| General Study Protocol Parameters |
| Study Design |
Randomized Clinical Trial
|
| Data Source |
New Data Collection
|
| Comparison Group |
Concurrent Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: At least 22 yrs
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Continued follow-up of premarket cohort: RCT
|
| Study Population |
Test: Ranger DCB
Control: PTA
|
| Sample Size |
376
|
| 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 lesion revascularization (CD-TLR) at 24 months.
The endpoints to be assessed through 5 years post-procedure are rate of: (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) arterial thrombosis and (7) mortality status. 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 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 |
376 enrolled
(Ranger DCB – 278 / Standard PTA – 98)
|
| Actual Number of Sites Enrolled |
67 sites enrolled
|
| Patient Follow-up Rate |
Overall follow-up was 84.4%
(Ranger DCB – 85.3% / Standard PTA – 81.7%)
|
| Final Safety Findings |
60 months MAE was 73.2% (156/213) for the Ranger DCB, and 68.5% (50/73) for Standard PTA.
Mortality at 60 month follow up was 16.1% (40/248) for the Ranger DCB, and 18.8% (16/85) for Standard PTA.
|
| Final Effect Findings |
Primary Patency rate for the Ranger DCB was 66.8% (125/187) at 36 months. Primary Patency rate for the Standard PTA was 62.5% (45/72) at 36 months.
|
| Study Strengths & Weaknesses |
This was a global, prospective, multi-center, single-blind, superiority, 3:1 (Ranger DCB vs. Standard PTA) controlled randomized clinical trial. Follow-up was 85.3% for the Ranger DCB and 81.7% for Standard PTA. There was no hypothesis testing on the follow-up results.
|
| Recommendations for Labeling Changes |
A labeling update will be requested to include the longer-term data in the IFU.
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