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

Sponsor

Can Tho Stroke International Services Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05666388

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Ischemic Stroke, Acute Stent Stenosis Thrombosis	Procedure: Rescue stenting	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

13 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 1, 2020

Actual Primary Completion Date :

Aug 31, 2022

Actual Study Completion Date :

Nov 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Rescue stenting (RESFIT) Rescue stenting in the severe atherosclerotic stenosis after the failure of intravenous thrombolysis (RESFIT)	Procedure: Rescue stenting Rescue stenting in the severe atherosclerotic stenosis after the failure of intravenous thrombolysis (RES

Arm

Intervention/Treatment

Experimental: Rescue stenting (RESFIT)

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

Procedure: Rescue stenting

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

Outcome Measures

Primary Outcome Measures

The incidence of hemorrhagic transformation [24 hours after rescue intracranial stenting.]
Hemorrhagic transformation was accessed by CT scan or MRI.
The rate of good outcomes at 3-month follow-up [3 months]
The good 3-month outcome rate was accessed by modified Rankin Score (mRS) < 3.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.