Clinical Data › RANGER II SFA Pivotal Trial

RANGER II SFA Pivotal Trial

Ranger Paclitaxel-Coated PTA Balloon Catheter

Ranger DCB is expected to enter the US market supported by robust clinical evidence, including head-to-head data vs IN.PACT™ DCB

  • Built on the market-leading 0.018" Sterling™ Balloon Platform*
  • Designed with a low drug dose (2ug/mm2) and proprietary TransPax™ coating technology
  • Expected US Launch: 2020

*DRG data, 0.018" PTA. Rolling 12 data through Nov 2019

Objective

To prove superior performance of the Ranger paclitaxel-coated PTA balloon catheter for angioplasty of femoropopliteal artery lesions when compared to standard PTA balloons. 

Trial Design

Prospective, multi-center, randomized controlled trial (3:1 Ranger DCB vs standard PTA balloon). Follow up through 5 years.

KEY BASELINE CHARACTERISTICS RANGER DCB
(n=278)
PTA
(n=98)
Age (year) 70.6 69.1
Smoker (current/previous) 85.3% 84.7%
Current Diabetes Mellitus 42.4% 43.9%
Target Lesion Length (mm)1 82.5 79.9
Calcium: PACSS Grade 3/42 47.8% 62.2%
1. Core lab
2. PACSS Grade 3/4 may be considered similar to moderate/severe calcification.
12-Month Primary Patency
3. 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 subjects entered in the calculation at the time interval.
** Log-rank p-value compares the entire K-M curves from time zero to full one year follow-up window.
RESULTS RANGER PTA p-value
Primary Safety Endpoint
(Freedom from MAE)
94.1%
(241/256)
83.5%
(76/91)
Pnon-inferiority<0.0001
Primary Effectiveness Endpoint
(Binary Primary Patency)
82.9%
(194/234)
66.3%
(57/86)
0.0017
 

CD-TLR & Mortality

Compared to PTA, Ranger demonstrated:

  • Significantly lower TLR
  • No difference in mortality
CD-TLR and Mortality charts
4. At risk denotes the number subjects entered in the calculation at the time interval.
5. Log-rank p-value compares the entire K-M curves from time zero to full one year follow-up window.

Ranger PK Substudy

Ranger PK Substudy

Study Method

  • Protocol required blood draws: Baseline, 10 minutes, 30 minutes 1, 3, 6, 24 or 48 hours.
  • All 12 patients received Ranger DCB
  • Average number of DCBs used per patient: 1.75
6. Measurable level is 1.0 ng/ml.
7. Paclitaxel in the blood stream was below measurable levels at 3 hours in all 12 patients.

Over 1500 patients are being studied in Ranger DCB clinical programs (Ranger DCB and comparator combined) in over 100 global sites. Between BSC-sponsored studies and physician-sponsored research Ranger DCB has shown consistent results in clinical trials. 

CAUTION: Ranger is an Investigational Device. Limited by Federal (or US) law to investigational use only. Not available for sale. Ranger™ Paclitaxel Coated PTA Balloon Catheter is manufactured by Hemoteq AG. 
 
 
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