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.

 

12-MONTH RESULTS:

Compare Trial 12-Month Kaplan-Meier Primary Patency Results
* Log-rank p-value compares the entire K-M curves from time zero to full one year follow-up window.
 
PRIMARY ENDPOINTS RANGER IN.PACT p-value
Binary Primary Patency 83.0%
(156/188)
81.5%
(141/173)
Pnon-inferiority<0.01
Freedom from major adverse events 91.0%
(182/200)
92.6%
(175/189)
Pnon-inferiority<0.01
Both primary endpoints met.
 
TRIAL DETAILS RANGER
(n=207)
IN.PACT
(n=207)
p-value
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
Excipient TransPax™
citrate ester
Urea N/A

 

BASELINE CHARACTERISTICS RANGER
(n=207)
IN.PACT
(n=207)
p-value
Age (year) 68.2 68.4 0.79
Female 38.2% 36.2% 0.68
Current/Former Smoker 77.3% 75.3% 0.63*
Total Occlusions 41% 43% 0.62
Total Occlusion Length 131 mm 113 mm 0.23
Target Lesion Length 124 mm 128 mm 0.65
Moderate to Severe Calcification** 50% 57% ***
Diabetics 31% 37% 0.18
* 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
(n=207)
IN.PACT
(n=207)
p-value
Mortality: All Cause 2.5% 1.6% 0.73
Mortality: Device or procedure related 0% 0% N/A
CD-TLR 9.0% 7.4% 0.59
 

Definitions

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. 

CAUTION: Ranger is an Investigational Device. Limited by Federal (or US) law to investigational use only. Not available for sale. Ranger™ Paclitaxel Coated PTA Balloon Catheter is manufactured by Hemoteq AG. 
 
 
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