DEVT: A randomized, controlled, multicenter trial of direct endovascular treatment versus standard bridging therapy for acute stroke patients with large vessel occlusion in the anterior circulation - Protocol

Int J Stroke. 2021 Feb;16(2):229-235. doi: 10.1177/1747493020925349. Epub 2020 May 23.

Abstract

Background: Eight randomized controlled trials have consistently shown that endovascular treatment plus best medical treatment improves outcome after acute anterior proximal intracranial large vessel occlusion strokes. Whether intravenous thrombolysis prior to endovascular treatment in patients with anterior circulation, large vessel occlusion is of any additional benefits remains unclear.

Objective: This study compares the safety and efficacy of direct endovascular treatment versus intravenous recombinant tissue-type plasminogen activator bridging with endovascular treatment (bridging therapy) in acute stroke patients with intracranial internal carotid artery or middle cerebral artery-M1 occlusion within 4.5 h of symptom onset.

Methods and design: The DEVT study is a randomized, controlled, multicenter trial with blinded outcome assessment. This trial uses a five-look group-sequential non-inferiority design. Up to 194 patients in each interim analysis will be consecutively randomized to direct endovascular treatment or bridging therapy group in 1:1 ratio over three years from about 30 hospitals in China.

Outcomes: The primary end-point is the proportion of independent neurological function defined as modified Rankin scale score of 0 to 2 at 90 days. The primary safety measure is symptomatic intracerebral hemorrhage at 48 h and mortality at 90 days.

Trial registry number: ChiCTR-IOR-17013568 (www.chictr.org.cn).

Keywords: Intravenous thrombolysis; acute ischemic stroke; bridging therapy; endovascular treatment; large vessel occlusion.

Publication types

  • Clinical Trial Protocol
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Cerebral Hemorrhage / drug therapy
  • Fibrinolytic Agents / therapeutic use
  • Humans
  • Multicenter Studies as Topic
  • Randomized Controlled Trials as Topic
  • Stroke* / drug therapy
  • Thrombectomy
  • Tissue Plasminogen Activator / therapeutic use

Substances

  • Fibrinolytic Agents
  • Tissue Plasminogen Activator

Associated data

  • ChiCTR/ChiCTR-IOR-17013568