Ranger II SFA Pivotal Trial1

12-Month results from the Ranger II SFA Pivotal Trial, a prospective, multi-center, randomized controlled trial

(3:1 Ranger DCB vs. uncoated balloon). 
Primary safety endpoint was freedom from MAE and primary effectiveness endpoint was binary primary patency.

12-Month Primary Patency
1. RANGER II SFA Pivotal Trial 12-Month Results presented by Marianne Brodmann. LINC 2020. 12-Month Primary Endpoints: Binary Primary Patency = 82.9% for Ranger DCB and 66.3% for PTA (p= <0.0017). Freedom from Major Adverse Events = 94.1% for Ranger DCB and 83.5% for PTA (Pnon-inferiority <0.0001)
2. 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
3. At risk denotes the number subjects entered in the calculation at the time interval.
4. Log-rank p-value compares the entire K-M curves from time zero to full one year follow-up window.

Ranger PK Substudy5

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
  • Measurable level is 1.0 ng/ml.

5. RANGER II SFA PK Substudy presented by Ravish Sachar, MD. VIVA 2019.

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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