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 demonstrated nearly 90% K-M primary patency at 12 months

line
12-Month Primary Patency
 

Primary safety endpoint was freedom from MAE and primary effectiveness endpoint was binary primary patency.

  
PRIMARY ENDPOINTS 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
 
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.
  

Clinically Driven TLR (CD-TLR) & Mortality

Ranger demonstrated significantly lower CD-TLR and no difference in mortality vs. PTA at 12 months.

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

  • Designed to evaluate the levels of paclitaxel in the systemic circulation of 12 subjects who were treated with Ranger DCB
  • Protocol required blood draws: Baseline, 10 minutes, 30 minutes, 1, 3, 6, 24 or 48 hours, 7 days and 30 days after last Ranger DCB treatment and removal
  • The limit of quantification was defined as < 1 ng/mL
  • Average number of DCBs used per patient: 1.75

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

 

Ranger is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. All other trademarks are the property of their respective owners.

 

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