A Multicenter, Parallel, Blinded, Randomized Comparison of the Safety and Efficacy of Balloon Angioplasty Plus Intraluminal SBCV To Balloon Angioplasty Alone for Treatment of Stenosis or Occlusion Within the Femoropopliteal Artery

Trial Profile

A Multicenter, Parallel, Blinded, Randomized Comparison of the Safety and Efficacy of Balloon Angioplasty Plus Intraluminal SBCV To Balloon Angioplasty Alone for Treatment of Stenosis or Occlusion Within the Femoropopliteal Artery

Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 22 May 2017

At a glance

  • Drugs SB 030 (Primary)
  • Indications Peripheral arterial disorders; Vascular disorders
  • Focus Adverse reactions; First in man; Proof of concept; Therapeutic Use
  • Acronyms SHIELD
  • Most Recent Events

    • 22 May 2017 Based on a review of interim results from the SHIELD study in Type B pre-IND meeting, the FDA recommended proceeding with a Phase 3 registration trial (see profile 285234), as reported in a Symic Bio media release.
    • 24 Feb 2017 According to a Symic Bio media release, top-line results of safety and efficacy are expected in fourth quarter of 2017.
    • 08 Feb 2017 Planned End Date changed from 1 Jun 2017 to 1 Oct 2017.
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