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

Thrombosis Clinical Trial

— RESFIT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05666388
• Other study ID #: RESFIT study
• Status: Completed
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: November 30, 2022

Study information

• Verified date: December 2022
• Source: Can Tho Stroke International Services Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: November 30, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Ischemic Stroke
• Stent Stenosis
• Stroke
• Thrombosis

Intervention

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

Locations

Country	Name	City	State
Vietnam	Can Tho SIS Hospital	C?n Tho

Sponsors (1)

Lead Sponsor	Collaborator
Can Tho Stroke International Services Hospital

Country where clinical trial is conducted

Vietnam, 

References & Publications (4)

Kwon DH, Jang SH, Park H, Sohn SI, Hong JH. Emergency Cervical Carotid Artery Stenting After Intravenous Thrombolysis in Patients With Hyperacute Ischemic Stroke. J Korean Med Sci. 2022 May 16;37(19):e156. doi: 10.3346/jkms.2022.37.e156. — View Citation

Sallustio F, Koch G, Rocco A, Rossi C, Pampana E, Gandini R, Meschini A, Diomedi M, Stanzione P, Di Legge S. Safety of early carotid artery stenting after systemic thrombolysis: a single center experience. Stroke Res Treat. 2012;2012:904575. doi: 10.1155/2012/904575. Epub 2011 Aug 8. — View Citation

Stracke CP, Fiehler J, Meyer L, Thomalla G, Krause LU, Lowens S, Rothaupt J, Kim BM, Heo JH, Yeo LLL, Andersson T, Kabbasch C, Dorn F, Chapot R, Hanning U. Emergency Intracranial Stenting in Acute Stroke: Predictors for Poor Outcome and for Complications. J Am Heart Assoc. 2020 Mar 3;9(5):e012795. doi: 10.1161/JAHA.119.012795. Epub 2020 Mar 3. — View Citation

Tran CC, Le MT, Baxter BW, Nguyen-Luu G, Ngo MT, Nguyen-Dao NH, Duong-Hoang L, Mai-Van M, Nguyen MD. Rescue intracranial stenting in acute ischemic stroke: a preliminary Vietnamese study. Eur Rev Med Pharmacol Sci. 2022 Oct;26(19):6944-6952. doi: 10.26355/eurrev_202210_29875. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of hemorrhagic transformation	Hemorrhagic transformation was accessed by CT scan or MRI.	24 hours after rescue intracranial stenting.
Primary	The rate of good outcomes at 3-month follow-up	The good 3-month outcome rate was accessed by modified Rankin Score (mRS) < 3.	3 months