TAKE THE FIGHT TO PAD
Bold moves for
Bold moves for
exceptional outcomes
Clinical Results
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 DCB demonstrated exceptional outcomes at 2-Years. No matter the lesion complexity. No matter the patient1.
1. RANGER II SFA RCT 2-Year Results presented by Ravish Sachar, MD. VIVA 2021.
2-Year Subgroup Analysis
Ranger DCB delivered exceptional outcomes in complex lesions at 2-Years
Ranger DCB demonstrated low reintervention rates regardless of patient gender
** 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 PK Sub Study2
Ranger II SFA Pivotal Trial Details
| 1-Year Primary Endpoint Results | Ranger DCB (n=207) |
PTA (n=98) |
p-value |
|---|---|---|---|
| Primary Safety Endpoint (Freedom from MAE) |
94.1% (241/256) |
83.0% (76/91) |
P non-inferiority ‹0.0001 |
| Primary Effectiveness Endpoint (Binary Primary Patency) |
82.9% (194/234) |
66.3% (57/86) |
0.0017 |
| Baseline Patient & Lesion Characteristics | Ranger DCB (n=278) |
PTA (n=98) |
p-value |
|---|---|---|---|
| Age (Year) | 70.6 | 69.1 | 0.1887 |
| Women | 37.8% | 31.6% | 0.2769 |
| Smoking History | 0.0303 | ||
| Current/Previous | 31.3% / 54.0% | 45.9% / 38.8% | N/A |
| Never/Unknown | 14.4% / 0.4% | 15.3% / 0.0% | N/A |
| Diabetes Mellitus | 42.4% | 43.9% | 0.8055 |
| Lesion Length (mm) | 82.5 | 79.9 | 0.655 |
| Moderate Calcium (PACSS Grade 3) | 36.3% | 52.0% | 0.006 |
| Severe Calcium (PACSS Grade 4) | 11.5% | 10.2% | 0.724 |
| 100% (Occlusion) | 18.3% | 29.6% | 0.019 |
| 1-Year Key Results | Ranger DCB (n=278) |
PTA (n=98) |
p-value |
|---|---|---|---|
| CD-TLR | 5.5% | 16.5% | 0.0011 |
| K-M All-Cause Mortality | 1.9% | 2.1% | 0.8794 |
| 2-Year Key Results | Ranger DCB (n=278) |
PTA (n=98) |
p-value |
|---|---|---|---|
| K-M Freedom from TLR | 87.4% | 79.5% | 0.0316* |
| Mod/Sev Calcium Subgroup K-M Freedom from TLR | 90.9% | 79.6% | 0.0246* |
| CTO Subgroup K-M Freedom from TLR | 85.6% | 62.8% | 0.0172* |
| All-Cause Mortality | 5.7% | 3.2% | 0.4218 |
COMPARE Randomized Controlled Trial Results1
COMPARE is the World’s First Head-to-Head Prospective, RCT (1:1) directly comparing SFA DCBs – low dose Ranger DCB vs higher dose IN.PACT DCB.
Ranger DCB demonstrated similar primary patency as IN.PACT at 2-Years1 with half the total drug dose2.
1. COMPARE Clinical Trial 2-Year Results presented by Sabine Steiner, MD. LINC 2021.
2. Based on total drug dose for (4mmx60mm) or (averages for full size matrix) per the Ranger™ Paclitaxel-Coated PTA Balloon Catheter and IN.PACT™ Admiral Instructions for Use.
COMPARE Randomized Controlled Trial Details
| 1-Year Primary Endpoints | Ranger DCB | IN.PACT | p-value |
|---|---|---|---|
| Binary Primary Patency* | 83.0% (156/188) |
81.5% (141/173) |
P non-inferiority ‹0.01 |
| Freedom from Major Adverse Events | 91.0% (182/200) |
92.6% (175/189) |
P non-inferiority ‹0.01 |
| Drug Dose Details | Ranger DCB (n=207) |
IN.PACT (n=207) |
p-value |
|---|---|---|---|
| Excipient | TransPax™ citrate ester |
Urea | N/A |
| Paclitaxel dose density | 2.0 μg/mm2 | 3.5 μg/mm2 | N/A |
| Average total paclitaxel dose per patient in trial | 6,971 μg | 13,035 μg | ‹0.0001 |
| Baseline Characteristics | Ranger DCB (n=207) |
IN.PACT (n=207) |
p-value |
|---|---|---|---|
| Age | 68.2 | 68.4 | 0.79 |
| Female | 38.2% | 36.2% | 0.68 |
| Current/Former Smoker | 77.3% | 75.3% | 0.63* |
| Total Occlusions | 41% | 43% | 0.62 |
| Total Occlusion Length | 131 mm | 113 mm | 0.23 |
| Target Lesion Length | 124 mm | 128 mm | 0.65 |
| Moderate to Severe Calcification** | 51% | 57% | *** |
| Diabetics | 31% | 37% | 0.18 |
** PACSS Grade 3/4 may be considered similar to moderate/severe calcification.
*** p-value for entire distribution of PACSS Calcium Grades 0, 1, 2, 3, 4 calcium for RANGER DCB vs IN.PACT p-value was 0.20.
| 1-Year Key Results | Ranger DCB (n=207) |
IN.PACT (n=207) |
p-value |
|---|---|---|---|
| Mortality: All Cause | 2.5% | 1.6% | 0.73 |
| Mortality: Device or Procedure Related | 0% | 0% | N/A |
| CD-TLR | 9.0% | 7.4% | 0.59 |
| 2-Year Key Results | Ranger DCB (n=207) |
IN.PACT (n=207) |
p-value |
|---|---|---|---|
| Mortality: All Cause | 3.6% | 2.2% | 0.6 |
| Mortality: Device or Procedure Related | 0% | 0% | N/A |
| CD-TLR | 17.3% | 13.0% | 0.3 |
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).
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