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RANGER II SFA clinical trial results

RANGER II SFA pivotal trial

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

Ranger DCB demonstrated exceptional outcomes at 2-Years.

No matter the lesion complexity. No matter the patient.


Ranger demonstrated the highest ever reported 2-Year Kaplan-Meier primary patency for a DCB in an RCT.

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.

Ranger DCB demonstrated low reintervention rates regardless of patient gender.

Bar chart showing Ranger DCB vs PTA
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

  Ranger DCB
Primary safety endpoint
(Freedom from MAE)
P non-inferiority
Primary effectiveness endpoint
(Binary primary patency)
  Ranger DCB
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 valcium (PACSS grade 4) 11.5% 10.2% 0.724
100% (occlusion) 18.3% 29.6% 0.019

  Ranger DCB
CD-TLR 5.5% 16.5% 0.0011
K-M all-cause mortality 1.9% 2.1% 0.8794
  Ranger DCB
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)

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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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.