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

Not Applicable

Completed

• Conditions: Thrombosis; Ischemic Stroke, Acute; Stent Stenosis
• Interventions: Procedure: Rescue stenting

• Registration Number: NCT05666388
• Lead Sponsor: Can Tho Stroke International Services Hospital

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.

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 Timeline

• Study Start: 2020-05-01
• Primary Completion: 2022-08-31
• Study Completion: 2022-11-30
• Status Verified: 2022-12
• Study First Submitted: 2022-12-17
• Study First Submitted QC: 2022-12-17
• Last Update Submitted: 2022-12-24
• Study First Posted: 2022-12-27
• Last Update Posted: 2022-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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.
The incidence of hemorrhagic transformation	24 hours after rescue intracranial stenting.	Hemorrhagic transformation was accessed by CT scan or MRI.

Trial Locations

Locations (1)

Can Tho SIS Hospital; 🇻🇳 Cần Thơ, Vietnam