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A Prospective, Randomized, Non-Inferiority Trial to Determine the Safety and Efficacy of the BA9TM Drug Coated Balloon for the Treatment of In-Stent Restenosis: First-in-Man Trial (REFORM)

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Trial Profile

A Prospective, Randomized, Non-Inferiority Trial to Determine the Safety and Efficacy of the BA9TM Drug Coated Balloon for the Treatment of In-Stent Restenosis: First-in-Man Trial (REFORM)

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 16 Aug 2022

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At a glance

  • Drugs Umirolimus (Primary) ; Paclitaxel
  • Indications Coronary artery restenosis
  • Focus First in man; Therapeutic Use
  • Acronyms REFORM
  • Sponsors Biosensors Europe

Most Recent Events

  • 09 Aug 2022 Planned End Date changed from 1 Apr 2023 to 1 Apr 2024.
  • 09 Aug 2022 Planned primary completion date changed from 1 Oct 2021 to 1 Apr 2023.
  • 09 Aug 2022 Status changed from recruiting to active, no longer recruiting.

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