RANGER™ Paclitaxel-Coated PTA Balloon Catheter
RANGER II SFA Pivotal Trial1
RANGER II SFA PIVOTAL TRIAL1
Prospective, Multi-Center, Randomised Controlled Trial Ranger Drug-Coated Balloon vs. Uncoated Balloon (3:1).
Follow-up through 5 years
Ranger demonstrated nearly 90% K-M primary patency at 12 months
Primary safety endpoint was freedom from MAE and primary effectiveness endpoint was binary primary patency.
| PRIMARY ENDPOINTS | RANGER | PTA | p-value |
|---|---|---|---|
| Primary Safety Endpoint (Freedom from MAE) |
94.1% (241/256) |
83.5% (76/91) |
Pnon-inferiority<0.0001 |
| Primary Effectiveness Endpoint (Binary Primary Patency) |
82.9% (194/234) |
66.3% (57/86) |
0.0017 |
Clinically Driven TLR (CD-TLR) & Mortality
Ranger demonstrated significantly lower CD-TLR and no difference in mortality vs. PTA at 12 months.
Ranger PK Substudy5
Study Method
- Designed to evaluate the levels of paclitaxel in the systemic circulation of 12 subjects who were treated with Ranger DCB
- Protocol required blood draws: Baseline, 10 minutes, 30 minutes, 1, 3, 6, 24 or 48 hours, 7 days and 30 days after last Ranger DCB treatment and removal
- The limit of quantification was defined as < 1 ng/mL
- Average number of DCBs used per patient: 1.75
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