Disclaimer

For health care professionals in EUROPE excepted those practicing in France as the following pages are intended to all International health care professionals and are not in compliance with the French Advertising law N°2011-2012 dated 29th December 2011 article 34. Other health care professionals should select their country in the top right corner of the  website.

Please note that the following pages are exclusively reserved for health care professionals in countries with applicable health authority product registrations. To the extent this site contains information, reference guides and databases intended for use by licensed medical professionals, such materials are not intended to offer professional medical advice. Prior to use, please consult device labeling for prescriptive information and operating instructions.

This Website is protected by the laws on copyright and by the relevant international conventions. It is strictly forbidden to make copies, whether partial or total and on whichever media without prior approval.

Ranger banner image

RANGER DCB VS. IN.PACT DCB

COMPARE clinical trial results

COMPARE randomised 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 randomised controlled trial details

  Ranger DCB IN.PACT p-value
Binary primary patency* 83.0%
(156/188)
81.5%
(141/173)
P non-inferiority
‹0.01
Freedom from major adverse events 91.0%
(182/200)
92.6%
(175/189)
P non-inferiority
‹0.01

*Primary Endpoint Met.

  Ranger DCB
(n=207)
IN.PACT
(n=207)
p-value
Excipient TransPax™
citrate ester
Urea N/A
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
  Ranger DCB
(n=207)
IN.PACT
(n=207)
p-value
Age 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** 51% 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 DCB vs IN.PACT p-value was 0.20.


  Ranger DCB
(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
  Ranger DCB
(n=207)
IN.PACT
(n=207)
p-value
Mortality: all cause 3.6% 2.2% 0.6
Mortality: device or procedure related 0% 0% N/A
CD-TLR 17.3% 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).

Ordering and reimbursement

Get downloads for ordering information and reimbursement coding guides for our drug-eluting technologies.

Stay up to date

Receive emails about the latest drug-eluting technology news, innovations and events in your area.

Caution:
The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings, and instructions for use can be found in the product labelling supplied with each device or at www.IFU-BSCI.com. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. This material not intended for use in France.