RANGER™ Paclitaxel Coated Balloon vs Standard Balloon Angioplasty
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
Summary
- Conditions
- Artery Diseases, Peripheral
- Atherosclerosis
- Occlusive Arterial Disease
- Peripheral Artery Disease
- Plaque, Atherosclerotic
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: The RANGER™ investigational device is coated with the drug paclitaxel.Masking: Single (Participant)Masking Description: Subjects will be blinded to treatment assigned and treatment received until completion of all 12 month follow-up visits (primary endpoint).Primary Purpose: Treatment
Participation Requirements
- Age
- Between 20 years and 125 years
- Gender
- Both males and females
Description
The RANGER II SFA is a global, prospective, multi-center clinical trial. Approximately 446 subjects will be enrolled at up to 80 study centers worldwide. Regions participating include the United States, Canada, European Union, Japan and New Zealand. The trial consists of a single-blind, superiority,...
The RANGER II SFA is a global, prospective, multi-center clinical trial. Approximately 446 subjects will be enrolled at up to 80 study centers worldwide. Regions participating include the United States, Canada, European Union, Japan and New Zealand. The trial consists of a single-blind, superiority, 3:1 (Ranger DCB vs. Standard PTA) randomized controlled trial (RCT) and a concurrent, non-randomized, single-arm, pharmacokinetic (PK) substudy, and a concurrent, non-blinded, non-randomized, Long balloon substudy.
Tracking Information
- NCT #
- NCT03064126
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Thomas Zeller, MD Universitaets-Herzzentrum Principal Investigator: Ravish Sachar, MD University of North Carolina - Rex Hospital
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