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A Prospective, Global, Multicenter, Single Arm Post-Approval Study Investigating the Clinical Use and Safety of the Lutonix Drug Coated Balloon PTA Catheter for the Treatment of Dysfunctional AV Fistulae

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Trial Profile

A Prospective, Global, Multicenter, Single Arm Post-Approval Study Investigating the Clinical Use and Safety of the Lutonix Drug Coated Balloon PTA Catheter for the Treatment of Dysfunctional AV Fistulae

Status: Recruiting
Phase of Trial: Phase IV

Latest Information Update: 10 Jan 2025

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At a glance

  • Drugs Paclitaxel (Primary)
  • Indications Arteriovenous fistula
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms AV PAS
  • Sponsors C.R. Bard

Most Recent Events

  • 07 Jan 2025 Planned End Date changed from 1 Sep 2029 to 1 Mar 2030.
  • 07 Jan 2025 Planned primary completion date changed from 1 Mar 2025 to 1 Sep 2025.
  • 06 Feb 2024 Planned End Date changed from 1 Jun 2027 to 1 Sep 2029.

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