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)||94.1%
|Primary Effectiveness Endpoint (Binary Primary Patency)||82.9%
2. Kaplan-Meier Estimate: Primary patency as determined by duplex ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) is ≤ 2.4 at the 12-month follow-up visit, in the absence of clinically-driven TLR or bypass of the target lesion.
* At risk denotes the number subjects entered in the calculation at the time interval.
** Log-rank p-value compares the entire K-M curves from time zero to full one year follow-up window.
Clinically Driven TLR (CD-TLR) & Mortality
Ranger demonstrated significantly lower CD-TLR and no difference in mortality vs. PTA at 12 months.
4. Log-rank p-value compares the entire K-M curves from time zero to full one year follow-up window.
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
5. RANGER II SFA PK Substudy presented by Ravish Sachar, MD. VIVA 2019.
Ranger is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. All other trademarks are the property of their respective owners.
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