RANGER Paclitaxel Coated Balloon vs Standard Balloon Angioplasty

    Not Recruiting
  • participants needed
  • sponsor
    Boston Scientific Corporation
Updated on 19 January 2022
balloon angioplasty
limb ischemia
lower limb ischemia


To evaluate the safety and effectiveness of the Ranger Paclitaxel Coated Balloon for treating lesions located in the superficial femoral and proximal popliteal arteries (SFA/PPA).

Long Balloon substudy: 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.


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.

Condition Atheroma, peripheral arterial disease, Arterial Occlusive Disease, Atherosclerosis
Treatment Paclitaxel, RANGER™ Paclitaxel Coated Balloon, Standard Balloon Angiplasty
Clinical Study IdentifierNCT03064126
SponsorBoston Scientific Corporation
Last Modified on19 January 2022

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