COMPARE Clinical Trial1
World’s first head-to-head, prospective, multi-center, Randomized Controlled Trial (1:1) comparing the low dose Paclitaxel RANGER™ DCB (2 µg/mm2) to the higher dose Paclitaxel IN.PACT™ DCB (3.5 µg/mm2)
- COMPARE Clinical Trial 12-Month Results presented by Sabine Steiner, MD. LINC 2020. 12-Month Primary Endpoints: Binary Primary Patency = 83.0% for Ranger DCB and 81.5% for IN.PACT DCB (Pnon-inferiority <0.01). Freedom from Major Adverse Events = 91.0% for Ranger DCB and 92.6% for IN.PACT DCB (Pnon-inferiority <0.01).
12-Month Kaplan-Meier Primary Patency
89.8%
versus PTA (74.0%)
Ranger II SFA Pivotal Trial2
Objective: To prove superior performance of the Ranger paclitaxel-coated PTA balloon catheter for angioplasty of femoropopliteal artery lesions when compared to standard PTA balloons.
- RANGER II SFA Pivotal Trial 12-Month Results presented by Marianne Brodmann. LINC 2020. 12-Month Primary Endpoints: Binary Primary Patency = 82.9% for Ranger DCB and 66.3% for PTA (p= <0.0017). Freedom from Major Adverse Events = 94.1% for Ranger DCB and 83.5% for PTA (Pnon-inferiority<0.0001).
Balloon Platform
Ranger is built on the market leading3 .018” Sterling Balloon Platform and is .014/.018” guidewire compatible.
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- Drug dose density = 2 μg/mm2
- COMPARE Clinical Trial 12-Month Full Cohort Results presented by Sabine Steiner, MD. LINC 2020. K-M Primary Patency = 88.4%.
RANGER II SFA Pivotal Trial 12-Month Results presented by Marianne Brodmann. LINC 2020. K-M Primary Patency = 89.8% - Gongora et al. Comparative Drug-Coated Balloon Study. JACC Cardiovasc Interv. 2015 doi.org/10.1016/j.jcin.2015.03.020
- RANGER II SFA PK Substudy presented by Ravish Sachar, MD. VIVA 2019.
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