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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Range Long Balloon, Ranger China & COMPARE I f/u


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General
Study Status Progress Adequate
Application Number P190019 / PAS002
Date Current Protocol Accepted  
Study Name Range Long Balloon, Ranger China & COMPARE I f/u
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description 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.



Study Population Description Ranger DCB



COMPARE I Study:

Subjects with peripheral artery disease (PAD) ranging from intermittent claudication to critical limb ischemia (Rutherford Category 2-4).
Sample Size Long Balloon Study: 50

China Study: 123

COMPARE I Study: 414 Total

207: Ranger DCB

Data Collection 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



Follow-up Visits and Length of Follow-up 1 year



COMPARE I Study: 5 years


Range Long Balloon, Ranger China & COMPARE I f/u Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 04/30/2021 04/29/2021 On Time
one year report 10/30/2021    
18 month report 04/30/2022    
two year report 10/30/2022    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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