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

NCT05666388 | Completed DMC

• 1 other identifier: RESFIT study
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke, Acute; Stent Stenosis; Thrombosis

Keywords

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

Outcome Measures

Primary Outcomes (2)

• The incidence of hemorrhagic transformation

  Hemorrhagic transformation was accessed by CT scan or MRI.

  24 hours after rescue intracranial stenting.

• 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

Study Arms (1)

Rescue stenting (RESFIT)

EXPERIMENTAL

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

Procedure: Rescue stenting

Interventions

Rescue stenting PROCEDURE

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

Rescue stenting (RESFIT)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Can Tho Stroke International Services Hospital: lead

Study Sites (1)

Can Tho SIS Hospital

Can Tho, 900000, Vietnam

Location

Related Publications (4)

• 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.

  PMID: 36263574 BACKGROUND

• 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.

  PMID: 21860810 BACKGROUND

• 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.

  PMID: 35578588 BACKGROUND

• 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.

  PMID: 32122218 BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke; Thrombosis

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Embolism and Thrombosis

Study Officials

• Cuong C Tran, Doctor

  Can Tho Stroke International Services General Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director - Doctor

Study Record Dates

• First Submitted: December 17, 2022
• First Posted: December 27, 2022
• Study Start: May 1, 2020
• Primary Completion: August 31, 2022
• Study Completion: November 30, 2022
• Last Updated: December 28, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)