Skip to main content
OpenTrials
Completed

NCT Number: NCT05666388

Rescue Stenting in the Severe Atherosclerotic Stenosis After the Failure of Intravenous Thrombolysis

Intravenous (IV) recombinant tissue plasminogen activator is the standard of care for patients with acute ischemic stroke (AIS) who present to the hospital within 4.5 hours of symptom onset. However, IV thrombolysis, even bridging thrombolysis (combining intravenous thrombolysis and mechanical thrombectomy) has limited efficacy among patients who had occlusive lesions associated with highgrade arterial stenosis requiring revascularization to improve neurological deficits. The investigators evaluated whether rescue stenting results in good outcomes among patients after the failure of intravenous thrombolysis and bridging thrombolysis.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Can Tho SIS Hospital

Can Tho, 900000, Vietnam

About this study

Stroke is the second most common cause of death worldwide, with an annual mortality rate of approximately 5.5 million. Depending on the timing of presentation, intravenous (IV) administration of recombinant tissue plasminogen activator can be an effective treatment, but is most effective when used between 3 and 4.5 hours of symptom onset. Bridging thrombolysis, which describes the combination of IV thrombolysis and mechanical thrombectomy, can lead to long-term functional independence after 90 days with higher recanalization success rates than IV thrombolysis alone without increased risk. The HERMES meta-analysis of fve trials (MR CLEAN, ESCAPE, REVASCAT, SWIFT PRIME, and EXTEND IA) indicated the potential benefits of mechanical thrombectomy (MT) in case of proximal circulation occlusions. The recanalization failure rate of this treatment, defined as a modified Thrombolysis in Cerebral Ischemia (mTICI) score of 2a or worse, remained high, ranging from 13% to 29%, and most patients experienced poor clinical outcomes. Permanent stent placement has been suggested as a potential approach for achieving successful recanalization, which is the goal of endovascular therapy in the early management of acute ischemic stroke (AIS). However, the risk of intracranial hemorrhage associated with the combined use of IV thrombolysis and a loading dose of dual antiplatelet therapy (DAPT) increases when rescue stenting is applied. The investigators hypothesize that stent deployment might serve as a feasible treatment for large artery occlusion after the failure of intravenous thrombolysis and bridging thrombolysis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Acute ischemic stroke who underwent rescue stenting for large vessel occlusions underlying severe atherosclerotic stenosis after the failure of intravenous alteplase therapy.
  • Absence of intracranial hemorrhage.

Exclusion criteria

  • Premorbid modified Rankin Scale (mRS) ≥ 2
  • Initiation to rescue stenting beyond 24 hours after symptom onset

Treatment and study plan

Rescue stenting

Procedure

Rescue stenting in the severe atherosclerotic stenosis after the failure of intravenous thrombolysis (RES

Primary outcomes

  1. The incidence of hemorrhagic transformation

    Time frame: 24 hours after rescue intracranial stenting.

    Hemorrhagic transformation was accessed by CT scan or MRI.

  2. The rate of good outcomes at 3-month follow-up

    Time frame: 3 months

    The good 3-month outcome rate was accessed by modified Rankin Score (mRS) < 3.

Sponsors and collaborators

Lead sponsor

Can Tho Stroke International Services Hospital

Other

Registry information

Official study title

Rescue Stenting in the Severe Atherosclerotic Stenosis After the Failure of Intravenous Thrombolysis: an Initial Vietnamese Report

Acronym: RESFIT

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 27, 2022
Registry last updated
Dec 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.