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
To prove superior performance of the Ranger paclitaxel-coated PTA balloon catheter for angioplasty of femoropopliteal artery lesions when compared to standard PTA balloons.
Prospective, multi-center, randomized controlled trial (3:1 Ranger DCB vs standard PTA balloon). Follow up through 5 years.
|KEY BASELINE CHARACTERISTICS||RANGER DCB
|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.|
* 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.
|Primary Safety Endpoint
(Freedom from MAE)
|Primary Effectiveness Endpoint
(Binary Primary Patency)
CD-TLR & Mortality
Compared to PTA, Ranger demonstrated:
- Significantly lower TLR
- No difference in mortality
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
- 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.
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