Clinical Data › COMPARE Clinical Trial
COMPARE Clinical Trial
Ranger Paclitaxel-Coated PTA Balloon Catheter
Ranger DCB is expected to enter the US market supported by robust clinical evidence, including head-to-head data vs IN.PACT™ DCB
- Built on the market-leading 0.018" Sterling™ Balloon Platform*
- Designed with a low drug dose (2ug/mm2) and proprietary TransPax™ coating technology
- Expected US Launch: 2020
*DRG data, 0.018" PTA. Rolling 12 data through Nov 2019
COMPARE CLINICAL TRIAL
12-Month Full Cohort Results
1Presented at LINC 2020 by Sabine Steiner, MD.
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 Manuscript published in the European Heart Journal. January 2020.
|Binary Primary Patency||83.0%
|Freedom from major adverse events||91.0%
|Both primary endpoints met.|
|Paclitaxel dose density||2.0 µg/mm2||3.5 µg/mm2||N/A|
|Average total paclitaxel dose per patient in trial||6,971 µg||13,035 µg||<0.0001|
|Total Occlusion Length||131 mm||113 mm||0.23|
|Target Lesion Length||124 mm||128 mm||0.65|
|Moderate to Severe Calcification**||50%||57%||***|
|* p-value based on entire distribution. Never, Former or Current Smokers
** PACSS Grade 3/4 may be considered similar to moderate/severe calcification
*** p-value for entire distribution of PACSS Calcium Grades 0, 1, 2, 3, 4 calcium for RANGER vs IN.PACT. p-value was 0.20.
|12 MONTH KEY RESULTS||RANGER
|Mortality: All Cause||2.5%||1.6%||0.73|
|Mortality: Device or procedure related||0%||0%||N/A|
Primary safety endpoint — composite of freedom from device and procedure-related death through 30-days and freedom from major target limb amputation and CD-TLR through 12 months post index-procedure.
Primary efficacy endpoint — primary patency at 12 months defined as absence of clinically-driven target lesion revascularization (CD-TLR) or binary restenosis determined as a peak systolic velocity ratio > 2.4 evaluated by duplex ultrasound core laboratory analysis.
CD-TLR — a reintervention performed for ≥ 50% diameter stenosis (confirmed by angiography) within ± 5 mm proximal and/or distal to the target lesion after documentation of recurrent clinical symptoms of PAD (increase of 1 Rutherford class or more) and/or drop of ABI (≥20% or ≥0.15 when compared to maximum early postprocedural level).
Over 1500 patients are being studied in Ranger DCB clinical programs (Ranger DCB and comparator combined) in over 100 global sites. Between BSC-sponsored studies and physician-sponsored research Ranger DCB has shown consistent results in clinical trials.
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