Recanalization and Stenting for Non-acute Veterbrobasilar Artery Occlusion

Recruiting

Phase N/A Results N/A

Trial Description

To evaluate whether recanalization and stenting for symptomatic subacute and chronic veterbrobasilar artery occlusion is technically feasible, can prevent from recurrent ischemic events and promotes functional recovery of disability.

Detailed Description

Ischemic stroke accounts for 87% of cerebrovascular accidents. Of these, a part is the result of intracranial veterbrobasilar occlusion. Acute veterbrobasilar artery occlusion is a devastating disease with high mortality without successful treatment. A subset of patients can survive the acute phase and develop subacute or chronic veterbrobasilar artery occlusion. Due to the adequacy of collaterals, some patients can live without any or just very mild symptoms. On the contrast, lack of enough collaterals, another patients still presented with recurrent ischemic events and progressive disability despite intensive medical therapy. Prognosis is extremely poor. It is in this cohort that subacute or chronic revascularization is often considered. The optimal treatment in this cohort with non-acute veterbrobasilar artery occlusion is unknown, and there is little literature to guide therapy. Extracranial-intracranial bypass may revascularize the intracranial artery occlusion. However, bypass procedures are technically challenging and are associated with significant risk of morbidity and mortality. Recurrent ischemic symptoms despite best medical treatment be indication for endovascular revascularization and stent remodeling. This study was to evaluate the technical feasibility, safety and treatment effects of recanalization and stenting for veterbrobasilar subacute-chronic intracranial artery occlusion。

Conditions

Interventions

  • Stenting Device
    Intervention Desc: Apollo stent (MicroPort Medical, China),Neuroform stent (Stryker/Boston Scientific, USA) or Wingspan stent (Stryker/Boston Scientific, USA), et al.
    ARM 1: Kind: Experimental
    Label: recanalization and stenting

Trial Design

  • Allocation: Non-Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change from Baseline in Modified Rankin Scale at Six Months postoperative two years Yes
Secondary Number of Participants with Adverse Events two to three years Yes
Secondary Changes from Baseline in NIHSS, BI and WHOQOL-BREF at Six Months postoperative two years Yes
Secondary Rate of Successful Recanalization two years Yes
Primary Changes from Baseline in Modified Rankin Scale (mRS) at one year postoperative one to three years Yes
Secondary Changes from Baseline in NIHSS (National Institutes of Health Stroke Scale) at Six Months postoperative six months to two years Yes
Secondary Changes from Baseline in BI (Barthel Index) at Six Months postoperative six months to two years Yes
Secondary Changes from Baseline in WHOQOL-BREF (The World Health Organization Quality of Life - BREF)at Six Months postoperative six months to two years Yes

Sponsors