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

NCT ID: NCT05666388

Last Updated: 2022-12-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-01
• Study Completion Date: 2022-11-30

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.

Conditions

Ischemic Stroke, Acute; Stent Stenosis; Thrombosis

Keywords

Ischemic stroke; Rescue stenting; Intravenous thrombolysis; Dual antiplatelet therapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rescue stenting (RESFIT)

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

Group Type: EXPERIMENTAL

Rescue stenting

Intervention Type: PROCEDURE

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

Interventions

Rescue stenting

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Can Tho Stroke International Services Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dr. Cuong Tran Chi

Director - Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cuong C Tran, Doctor

Role: STUDY_CHAIR

Can Tho Stroke International Services General Hospital

Locations

Can Tho SIS Hospital

Can Tho, , Vietnam

Countries

Vietnam

References

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.

Reference Type: BACKGROUND

PMID: 36263574 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21860810 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35578588 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32122218 (View on PubMed)

Other Identifiers

RESFIT study

Identifier Type: -

Identifier Source: org_study_id