Skip to main content

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 delivers exceptional outcomes backed by durable, long-term results.

12-month primary patency rates K-M Estimate¹*

12-month primary patency rates K-M estimate showing Ranger DCB: 89.8% and PTA: 74.0%

* Kaplan-Meier Estimate: Primary patency as determined by duplex ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) is ≤2.4 at the 12-month follow-up visit, in the absence of clinically driven TLR or bypass of the target lesion.

** At risk denotes the number of subjects entered in the calculation at the time interval.

*** Logrank p-value compares the entire K-M curves from time zero to full 1-year follow-up.

Ranger DCB demonstrated durability, with low reintervention rates through 4 years


94.5% at 1-Year

More than 9 in 10 patients did not need reintervention at 1 year

Icon of 10 purple patients

78.7% at 4-years

Nearly 8 in 10 patients did not need reintervention at 4 years

Icon of 8 purple patients vs 2 gray

Subjects at risk at day 365=255 subjects

Subjects at risk at day 1460=184 subjects

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 pivotal trial details

 Ranger DCB
Primary safety endpoint
(Freedom from MAE)
P non-inferiority
Primary effectiveness endpoint
(Binary primary patency)
 Ranger DCB
Age (year)70.669.10.1887
Smoking history  0.0303
Current/previous31.3% / 54.0%45.9% / 38.8%N/A
Never/unknown14.4% / 0.4%15.3% / 0.0%N/A
Diabetes mellitus42.4%43.9%0.8055
Lesion length (mm)82.579.90.655
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
K-M all-cause mortality1.9%2.1%0.8794
 Ranger DCB
K-M freedom from TLR87.4%79.5%0.0316*
Mod/Sev calcium subgroup K-M freedom from TLR90.9%79.6%0.0246*
CTO subgroup K-M freedom from TLR85.6%62.8%0.0172*
All-cause mortality5.7%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)
 Ranger DCB
3-year results   

K-M primary patency

4-year results   

All-cause mortality






K-M freedom from CD-TLR


Major Amputation


1 RANGER II SFA RCT 1-Year Results published in JACC:CI.

2 RANGER II SFA RCT 2-Year Results presented by Ravish Sachar, MD. VIVA 2021

3 Latest RCT update presented by Marianne Brodmann, MD at LINC 2023, Tuesday 06-June Main Arena 1 09:45 – 09:50

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.