RANGER II SFA PIVOTAL TRIAL1
Prospective, Multi-Center, Randomized 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 Safety Endpoint
(Freedom from MAE)
|Primary Effectiveness Endpoint
(Binary Primary Patency)
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
- 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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