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

Primary Purpose

Ischemic Stroke, Acute, Stent Stenosis, Thrombosis

Status
Completed
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
Rescue stenting
Sponsored by
Can Tho Stroke International Services Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke, Acute focused on measuring Ischemic stroke, Rescue stenting, Intravenous thrombolysis, Dual antiplatelet therapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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. Exclusion Criteria: Premorbid modified Rankin Scale (mRS) ≥ 2 Initiation to rescue stenting beyond 24 hours after symptom onset

Sites / Locations

  • Can Tho SIS Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rescue stenting (RESFIT)

Arm Description

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

Outcomes

Primary Outcome Measures

The incidence of hemorrhagic transformation
Hemorrhagic transformation was accessed by CT scan or MRI.
The rate of good outcomes at 3-month follow-up
The good 3-month outcome rate was accessed by modified Rankin Score (mRS) < 3.

Secondary Outcome Measures

Full Information

First Posted
December 17, 2022
Last Updated
December 24, 2022
Sponsor
Can Tho Stroke International Services Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05666388
Brief Title
Rescue Stenting in the Severe Atherosclerotic Stenosis After the Failure of Intravenous Thrombolysis
Acronym
RESFIT
Official Title
Rescue Stenting in the Severe Atherosclerotic Stenosis After the Failure of Intravenous Thrombolysis: an Initial Vietnamese Report
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
November 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Can Tho Stroke International Services Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke, Acute, Stent Stenosis, Thrombosis
Keywords
Ischemic stroke, Rescue stenting, Intravenous thrombolysis, Dual antiplatelet therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rescue stenting (RESFIT)
Arm Type
Experimental
Arm Description
Rescue stenting in the severe atherosclerotic stenosis after the failure of intravenous thrombolysis (RESFIT)
Intervention Type
Procedure
Intervention Name(s)
Rescue stenting
Intervention Description
Rescue stenting in the severe atherosclerotic stenosis after the failure of intravenous thrombolysis (RES
Primary Outcome Measure Information:
Title
The incidence of hemorrhagic transformation
Description
Hemorrhagic transformation was accessed by CT scan or MRI.
Time Frame
24 hours after rescue intracranial stenting.
Title
The rate of good outcomes at 3-month follow-up
Description
The good 3-month outcome rate was accessed by modified Rankin Score (mRS) < 3.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cuong C Tran, Doctor
Organizational Affiliation
Can Tho Stroke International Services General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Can Tho SIS Hospital
City
Cần Thơ
ZIP/Postal Code
900000
Country
Vietnam

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36263574
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.
Results Reference
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PubMed Identifier
21860810
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.
Results Reference
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PubMed Identifier
35578588
Citation
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.
Results Reference
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PubMed Identifier
32122218
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.
Results Reference
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Rescue Stenting in the Severe Atherosclerotic Stenosis After the Failure of Intravenous Thrombolysis

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