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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P190019 / PAS002 |
| Date Original Protocol Accepted |
12/16/2020
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| Date Current Protocol Accepted |
09/22/2023
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| Study Name |
Range Long Balloon, Ranger China & COMPARE I f/u
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| Device Name |
Ranger™ Paclitaxel-Coated PTA Balloon Catheter
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
To evaluate the safety and effectiveness of the Boston Scientific Corporation (BSC) Ranger™ Paclitaxel Coated Balloon in the 120, 150 and 200 mm lengths for treating Superficial Femoral Artery (SFA) and/or
Proximal Popliteal Artery (PPA) lesions.
COMPARE I Study:
To compare two different Paclitaxel coated balloons in the treatment of high grade stenotic or occluded lesions in SFA and/or PPA in PAD patients with Rutherford class 2-4. The trial is to investigate the safety and efficacy of the Ranger™ Drug Coated Balloon in comparison to the IN.PACT™ Drug Coated Balloon in patients with symptomatic femoropopliteal artery disease.
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| Study Population |
Ranger DCB
COMPARE I Study:
Subjects with peripheral artery disease (PAD) ranging from intermittent claudication to critical limb ischemia (Rutherford Category 2-4).
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| Sample Size |
Long Balloon Study: 50
China Study: 123
COMPARE I Study: 414 Total
207: Ranger DCB
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| Key Study Endpoints |
Long Balloon Study:
The primary safety endpoint assesses the occurrence of Major Adverse Events (MAE) defined as all-cause death through 1 month, target limb major amputation and/or target lesion revascularization (TLR) at 6 and 12
months post-index procedure.
The primary effectiveness endpoint assesses primary lesion patency at 6 months as determined by duplex ultrasound (DUS).
Mortality Status Annually
China Study:
The primary safety endpoint is the rate of following major adverse events through 30 days post-procedure:
all device and/or procedure related mortality
target limb major amputation at
Clinically-driven Target Lesion Revascularization (TLR)
The primary efficacy endpoint is primary lesion patency of the treated segment(s) as assessed by computed tomography angiography (CTA) at 12 months post-procedure without clinically-driven TLR.
Mortality Status Annually
COMPARE I Study:
Primary Efficacy: patency rate after one year defined as absence of clinically driven TLR (due to symptoms and drop of ABI of greater than or equal to 20% or > 0.15 when compared to post-procedure) or restenosis with PVR > 2.4 evaluated by Duplex Ultrasound.
Primary Safety: Composite of freedom from device and procedure-related death through 12 months post procedure as well as freedom from both target limb major amputation and clinically-driven target vessel revascularization.
Mortality Status Annually
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| Follow-up Visits and Length of Follow-up |
1 year
COMPARE I Study: 5 years
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
Long Balloon Substudy: 52 enrolled.
Ranger China Study: 123 enrolled.
COMPARE I Study: 414 enrolled
(Ranger DCB – 207 / In.Pact DCB – 207).
|
| Actual Number of Sites Enrolled |
Long Balloon Substudy: 7 sites enrolled.
Ranger China Study: 10 sites enrolled.
COMPARE I Study: 15 sites enrolled.
|
| Patient Follow-up Rate |
Long Balloon Substudy: 92.3%
Ranger China Study: 89.4%
COMPARE I Study: Ranger DCB – 74.9% / In.Pact DCB – 67.6%
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| Final Safety Findings |
Long Balloon Substudy: 12 Months MAE Free-Ranger DCB was 94.0% (47/50). Mortality at 12 month follow up was 5.8% (3/52). One additional death was reported after the 12 month follow up window (4 deaths total).
Ranger China Study: 12 Months MAE Free-Ranger DCB for the ITT and PP set was 96.6% (115/119). Mortality at 12 month follow up was 2.5% (3/122).
COMPARE I Study: 36 Months MAE Free-Ranger DCB (72.5%) and In.Pact DCB (78.6%). Mortality at 36 month follow up: 7.7% (13/168) for Ranger DCB and 6.0% (9/149) for In.PACT Admiral.
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| Final Effect Findings |
Long Balloon Substudy: Primary Patency Rate was 83.0% (39/47).
Ranger China Study: Initial vascular patency for the Ranger DCB ITT and PP set was 61.5% (64/104).
COMPARE I Study: Primary patency rate for the Ranger DCB was 83.0% (156/188) and 65.6% (116/177) at 12 and 24 months, respectively.
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| Study Strengths & Weaknesses |
Long Balloon Substudy: Strength – Includes data for worst case drug usage / Weakness - Low sample size, non-blinded.
Ranger China Study: Strength – Prospective and multi-center study / Weakness – Only one country.
COMPARE I Study: Strength – Large Sample Size, Prospective and multi-center study, 1:1 randomized clinical trial / Weakness – Only conducted in EU.
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| Recommendations for Labeling Changes |
N/A
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