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TAKE THE FIGHT TO PAD

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exceptional outcomes

 
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Clinical Results

 
Ranger™ Drug-Coated Balloon demonstrated exceptional outcomes at 2-Years in two Randomized Controlled Trials1. No matter the lesion complexity. No matter the patient.
 


RANGER II SFA Pivotal Trial1

Prospective, Multi-Center, Randomized Controlled Trial Ranger Drug-Coated Balloon vs. Uncoated Balloon (3:1). Follow-up through 5-Years.

Ranger DCB demonstrated exceptional outcomes at 2-Years. No matter the lesion complexity. No matter the patient1.

Preview of RANGER II SFA RCT RCT 2-year results animation
Chart of Ranger DCB Kaplan-Meier Primary Patency Results
*Log-rank p-value compares the entire K-M curves from time point zero to day 760 (full 2-year follow-up window)
1. RANGER II SFA RCT 2-Year Results presented by Ravish Sachar, MD. VIVA 2021.
 
 
2-Year Subgroup Analysis
Ranger DCB delivered exceptional outcomes in complex lesions at 2-Years
Bar chart showing Ranger DCB vs PTA
Ranger DCB demonstrated low reintervention rates regardless of patient gender
Bar chart showing 67% relative reduction of CD-TLR for Ranger DCB vs PTA
  *  PACSS Grade 3/4 Calcification
**  Log-rank p-value compares the entire K-M curves from time point zero to day 760 (full 2-year follow-up window)
*** Log-rank p-value compares the entire K-M curves from time point zero to day 730 (full 2-year annual visit mark)



RANGER II SFA PK Sub Study2
Infographic of Ranger study showing in 1 hour 11 out of 12 patients did not have measurable levels of paclitaxel in the bloodstream
2. The limit of quantification was defined as < 1 ng/mL. RANGER II SFA PK Substudy. RANGER II SFA RCT 1-Year Results published in JACC:CI. doi.org/10.1016/j.jcin.2021.03.021.



Ranger II SFA Pivotal Trial Details
1-Year Primary Endpoint Results Ranger DCB
(n=207)
PTA
(n=98)
p-value
Primary Safety Endpoint
(Freedom from MAE)
94.1%
(241/256)
83.0%
(76/91)
P non-inferiority
‹0.0001
Primary Effectiveness Endpoint
(Binary Primary Patency)
82.9%
(194/234)
66.3%
(57/86)
0.0017
 
Baseline Patient & Lesion Characteristics Ranger DCB
(n=278)
PTA
(n=98)
p-value
Age (Year) 70.6 69.1 0.1887
Women 37.8% 31.6% 0.2769
Smoking History     0.0303
Current/Previous 31.3% / 54.0% 45.9% / 38.8% N/A
Never/Unknown 14.4% / 0.4% 15.3% / 0.0% N/A
Diabetes Mellitus 42.4% 43.9% 0.8055
Lesion Length (mm) 82.5 79.9 0.655
Moderate Calcium (PACSS Grade 3) 36.3% 52.0% 0.006
Severe Calcium (PACSS Grade 4) 11.5% 10.2% 0.724
100% (Occlusion) 18.3% 29.6% 0.019
 
1-Year Key Results Ranger DCB
(n=278)
PTA
(n=98)
p-value
CD-TLR 5.5% 16.5% 0.0011
K-M All-Cause Mortality 1.9% 2.1% 0.8794
 
2-Year Key Results Ranger DCB
(n=278)
PTA
(n=98)
p-value
K-M Freedom from TLR 87.4% 79.5% 0.0316*
Mod/Sev Calcium Subgroup K-M Freedom from TLR 90.9% 79.6% 0.0246*
CTO Subgroup K-M Freedom from TLR 85.6% 62.8% 0.0172*
All-Cause Mortality 5.7% 3.2% 0.4218
  * Log-rank p-value compares the entire K-M curves from time point zero to day 730 (full 2-year annual visit mark)

 

COMPARE Randomized Controlled Trial Results1

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.

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

 Kaplan-Meier Primary Patency Results
*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
1-Year Primary Endpoints 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.
Drug Dose Details 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
 
Baseline Characteristics 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.

 

1-Year Key Results 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
 
2-Year Key Results 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).

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