RANGER Paclitaxel Coated Balloon vs Standard Balloon Angioplasty

  • STATUS
    Not Recruiting
  • participants needed
    446
  • sponsor
    Boston Scientific Corporation
Updated on 3 November 2021
Tokeidai Memorial Hospital (0.0 mi away) Contact
stenosis
paclitaxel
ischemia
balloon angioplasty
stenotic
limb ischemia
atherectomy
lower limb ischemia

Summary

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.

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, 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.

Details
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 on3 November 2021

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