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COMPARE randomized controlled trial results

COMPARE is the World’s First Head-to-Head Prospective, RCT (1:1) directly comparing SFA DCBs – low dose Ranger DCB vs higher dose IN.PACT DCB.1

Ranger DCB demonstrated similar primary patency as IN.PACT at 2-Years¹ with half the total drug dose².

BSC_DE_K-M_Chart_Ranger_v_IN.PACT_2_Year_V2 BSC_DE_K-M_Chart_Ranger_v_IN.PACT_2_Year_V2

*Log-rank p-value compares the entire K-M curves from time zero to full 2-Year follow-up window.

1. COMPARE Clinical Trial 2-Year Results presented by Sabine Steiner, MD. LINC 2021.

2. Based on total drug dose for (4mmx60mm) or (averages for full size matrix) per the Ranger™ Paclitaxel-Coated PTA Balloon Catheter and IN.PACT™ Admiral Instructions for Use.

COMPARE randomized controlled trial details

 Ranger DCBIN.PACTp-value
Binary primary patency*83.0%
(156/188)
81.5%
(141/173)
P non-inferiority
‹0.01
Freedom from major adverse events91.0%
(182/200)
92.6%
(175/189)
P non-inferiority
‹0.01

*Primary Endpoint Met.

 Ranger DCB
(n=207)
IN.PACT
(n=207)
p-value
ExcipientTransPax™
citrate ester
UreaN/A
Paclitaxel dose density2.0 μg/mm23.5 μg/mm2N/A
Average total paclitaxel dose per patient in trial 6,971 μg13,035 μg‹0.0001
 Ranger DCB
(n=207)
IN.PACT
(n=207)
p-value
Age68.268.40.79
Female38.2%36.2%0.68 
Current/Former Smoker77.3%75.3%0.63*
Total Occlusions41%43%0.62
Total Occlusion Length131 mm 113 mm0.23
Target Lesion Length124 mm128 mm0.65
Moderate to Severe Calcification**51%57%***
Diabetics31%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 DCB vs IN.PACT p-value was 0.20.


 Ranger DCB
(n=207)
IN.PACT
(n=207)
p-value
Mortality: all cause2.5%1.6%0.73
Mortality: device or procedure related0%0%N/A
CD-TLR9.0%7.4%0.59
 Ranger DCB
(n=207)
IN.PACT
(n=207)
p-value
Mortality: all cause3.6%2.2%0.6
Mortality: device or procedure related0%0%N/A
CD-TLR17.3%13.0%0.3

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 1-Year post index-procedure.

Primary efficacy endpoint: primary patency at 1-Year 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 post-procedural level).

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