Intracranial Stenting in Non-acute Symptomatic Ischemic Stroke (INSIS)
Primary Purpose
Intracranial Arteriosclerosis, Ischemic Stroke, Intracranial Arterial Diseases
Status
Unknown status
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
Medical treatment plus intracranial stenting
Medical treatment alone
Sponsored by
About this trial
This is an interventional prevention trial for Intracranial Arteriosclerosis focused on measuring Dual antiplatelet therapy, MRI 3 Tesla, WEAVE trial, WOVEN trial
Eligibility Criteria
Inclusion Criteria:
- Evidence of intracranial large severe stenosis or occlusive artery in angiography.
- Absence of intracranial hemorrhage.
- Premorbid mRS score is ≤ 3.
- Recurrent stroke in the target territory during the medical treatment for ischemic stroke prevention.
Exclusion Criteria:
- Tandem lesion.
- Loss to follow-up after discharge.
- A severe or fatal combined illness before acute ischemic stroke.
- Progressive neurologic deficit within 7 days after acute ischemic stroke.
- Large middle cerebral artery infarct within 30 days after acute ischemic stroke.
Sites / Locations
- Can Tho SIS HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Medical treatment plus intracranial stenting (MT plus IS)
Medical treatment alone (MT)
Arm Description
This group will be both given medical treatment (aspirin 100 mg and clopidogrel 75 mg per day for 90 consecutive days and clopidogrel 75 mg per day thereafter) and performed with intracranial stenting.
This group will be given medical treatment including aspirin 100 mg and clopidogrel 75 mg per day for 90 consecutive days and clopidogrel 75 mg per day thereafter.
Outcomes
Primary Outcome Measures
Rate of recurrent ischemic stroke of the qualifying lesion in the territory of the symptomatic intracranial artery.
Rate of recurrent ischemic stroke of the qualifying lesion in the territory of the symptomatic intracranial artery.
Secondary Outcome Measures
Death rate of the qualifying lesion in the territory of the symptomatic intracranial artery.
Death rate of the qualifying lesion in the territory of the symptomatic intracranial artery.
Rate of ischemic stroke recovery of the qualifying lesion in the territory of the symptomatic intracranial artery.
Rate of ischemic stroke recovery of the qualifying lesion in the territory of the symptomatic intracranial artery was accessed by modified Rankin Score (mRS).
Full Information
NCT ID
NCT05063630
First Posted
September 15, 2021
Last Updated
September 21, 2021
Sponsor
Can Tho Stroke International Services Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05063630
Brief Title
Intracranial Stenting in Non-acute Symptomatic Ischemic Stroke
Acronym
INSIS
Official Title
Intracranial Stenting in Non-acute Symptomatic Ischemic Stroke: an Open-label, Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
October 31, 2021 (Anticipated)
Study Completion Date
May 24, 2022 (Anticipated)
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
In non-acute symptomatic ischemic stroke, the decision-making of medical treatment plus intracranial stenting has been more and more popular, especially in patients with intracranial large severe stenosis or occlusive artery. Nonetheless, there is no evidence from randomized controlled trials evaluating the efficacy of this treatment after the Wingspan Stent System Post Market Surveillance (WEAVE) and Wingspan One Year Vascular Imaging Events and Neurologic Outcomes (WOVEN) trial compared with medical treatment alone. This trial was to investigate whether medical treatment plus intracranial stenting would prevent the recurrent ischemic stroke in the territory of the symptomatic intracranial artery during 1-year follow-up.
Detailed Description
In symptomatic ischemic stroke due to intracranial large severe stenosis or occlusive artery, the choice for treatment has remained controversial after results of the Stenting versus Aggressive Medical Therapy for Intracranial Arterial Stenosis (SAMMPRIS) trial because it demonstrated that the efficacy of medical treatment was superior to intracranial stenting in the low risk of periprocedural stroke or death. However, this conclusion has influenced the role of intracranial stenting in the ischemic stroke treatment and recovery time for a long time because of the unproper patient selection of this trial such as no evidence of medical failure, intracranial stenting earlier than 7 days after the stroke and intracranial stenting in patients with transient ischemic attacks only. Recently, the Food and Drug Administration (FDA) mandated study about intracranial stenting, WEAVE trial, reported not only 97.4% patients with no complication at 72 hours, but also a relatively low 8.5% recurrent stroke and death rate during 1 year in the WOVEN study. In case of the symptomatic stenosis greater than 70%, the probability of recurrent stroke and transient ischemic attack in the territory of the symptomatic stenotic artery in 1 year was 23% and 14%, respectively, despite treatment with antithrombotic therapy and standard management of vascular risk. Given a lot of patients with symptomatic ischemic stroke who have some adjustable indications for intracranial stenting deployment in the world and a paucity of evidence from randomized trials, the purpose of this trial was to compare this treatment versus medical one in the intracranial large severe stenosis or occlusive artery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Arteriosclerosis, Ischemic Stroke, Intracranial Arterial Diseases, Arterial Occlusive Diseases
Keywords
Dual antiplatelet therapy, MRI 3 Tesla, WEAVE trial, WOVEN trial
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Medical treatment plus intracranial stenting (MT plus IS)
Arm Type
Experimental
Arm Description
This group will be both given medical treatment (aspirin 100 mg and clopidogrel 75 mg per day for 90 consecutive days and clopidogrel 75 mg per day thereafter) and performed with intracranial stenting.
Arm Title
Medical treatment alone (MT)
Arm Type
Active Comparator
Arm Description
This group will be given medical treatment including aspirin 100 mg and clopidogrel 75 mg per day for 90 consecutive days and clopidogrel 75 mg per day thereafter.
Intervention Type
Procedure
Intervention Name(s)
Medical treatment plus intracranial stenting
Other Intervention Name(s)
MT plus IS
Intervention Description
This group will be both given medical treatment (aspirin 100 mg and clopidogrel 75 mg per day for 90 consecutive days and clopidogrel 75 mg per day thereafter) and performed with intracranial stenting.
Intervention Type
Drug
Intervention Name(s)
Medical treatment alone
Other Intervention Name(s)
MT
Intervention Description
This group will be given medical treatment including aspirin 100 mg and clopidogrel 75 mg per day for 90 consecutive days and clopidogrel 75 mg per day thereafter.
Primary Outcome Measure Information:
Title
Rate of recurrent ischemic stroke of the qualifying lesion in the territory of the symptomatic intracranial artery.
Description
Rate of recurrent ischemic stroke of the qualifying lesion in the territory of the symptomatic intracranial artery.
Time Frame
During 1 year after randomization.
Secondary Outcome Measure Information:
Title
Death rate of the qualifying lesion in the territory of the symptomatic intracranial artery.
Description
Death rate of the qualifying lesion in the territory of the symptomatic intracranial artery.
Time Frame
During 1 year after randomization.
Title
Rate of ischemic stroke recovery of the qualifying lesion in the territory of the symptomatic intracranial artery.
Description
Rate of ischemic stroke recovery of the qualifying lesion in the territory of the symptomatic intracranial artery was accessed by modified Rankin Score (mRS).
Time Frame
During 3 months after randomization..
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Evidence of intracranial large severe stenosis or occlusive artery in angiography.
Absence of intracranial hemorrhage.
Premorbid mRS score is ≤ 3.
Recurrent stroke in the target territory during the medical treatment for ischemic stroke prevention.
Exclusion Criteria:
Tandem lesion.
Loss to follow-up after discharge.
A severe or fatal combined illness before acute ischemic stroke.
Progressive neurologic deficit within 7 days after acute ischemic stroke.
Large middle cerebral artery infarct within 30 days after acute ischemic stroke.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cuong Tran Chi, Doctor
Phone
+84886559911
Email
drcuongtran@dotquy.vn
First Name & Middle Initial & Last Name or Official Title & Degree
Can Tho SIS Hospital
Phone
18001115
Email
cskh@dotquy.vn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cuong Tran Chi, Doctor
Organizational Affiliation
Can Tho SIS Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Can Tho SIS Hospital
City
Cần Thơ
ZIP/Postal Code
900000
Country
Vietnam
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cuong Tran Chi, Doctor
Phone
+84886559911
Email
drcuongtran@dotquy.vn
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21899409
Citation
Chimowitz MI, Lynn MJ, Derdeyn CP, Turan TN, Fiorella D, Lane BF, Janis LS, Lutsep HL, Barnwell SL, Waters MF, Hoh BL, Hourihane JM, Levy EI, Alexandrov AV, Harrigan MR, Chiu D, Klucznik RP, Clark JM, McDougall CG, Johnson MD, Pride GL Jr, Torbey MT, Zaidat OO, Rumboldt Z, Cloft HJ; SAMMPRIS Trial Investigators. Stenting versus aggressive medical therapy for intracranial arterial stenosis. N Engl J Med. 2011 Sep 15;365(11):993-1003. doi: 10.1056/NEJMoa1105335. Epub 2011 Sep 7. Erratum In: N Engl J Med. 2012 Jul 5;367(1):93.
Results Reference
background
PubMed Identifier
31125298
Citation
Alexander MJ, Zauner A, Chaloupka JC, Baxter B, Callison RC, Gupta R, Song SS, Yu W; WEAVE Trial Sites and Interventionalists. WEAVE Trial: Final Results in 152 On-Label Patients. Stroke. 2019 Apr;50(4):889-894. doi: 10.1161/STROKEAHA.118.023996.
Results Reference
background
PubMed Identifier
32561658
Citation
Alexander MJ, Zauner A, Gupta R, Alshekhlee A, Fraser JF, Toth G, Given C, Mackenzie L, Kott B, Hassan AE, Shownkeen H, Baxter BW, Callison RC, Yu W. The WOVEN trial: Wingspan One-year Vascular Events and Neurologic Outcomes. J Neurointerv Surg. 2021 Apr;13(4):307-310. doi: 10.1136/neurintsurg-2020-016208. Epub 2020 Jun 19.
Results Reference
background
PubMed Identifier
25803346
Citation
Zaidat OO, Fitzsimmons BF, Woodward BK, Wang Z, Killer-Oberpfalzer M, Wakhloo A, Gupta R, Kirshner H, Megerian JT, Lesko J, Pitzer P, Ramos J, Castonguay AC, Barnwell S, Smith WS, Gress DR; VISSIT Trial Investigators. Effect of a balloon-expandable intracranial stent vs medical therapy on risk of stroke in patients with symptomatic intracranial stenosis: the VISSIT randomized clinical trial. JAMA. 2015 Mar 24-31;313(12):1240-8. doi: 10.1001/jama.2015.1693.
Results Reference
background
PubMed Identifier
31422789
Citation
Markus HS, Larsson SC, Dennis J, Kuker W, Schulz UG, Ford I, Clifton A, Rothwell PM. Vertebral artery stenting to prevent recurrent stroke in symptomatic vertebral artery stenosis: the VIST RCT. Health Technol Assess. 2019 Aug;23(41):1-30. doi: 10.3310/hta23410.
Results Reference
background
Learn more about this trial
Intracranial Stenting in Non-acute Symptomatic Ischemic Stroke
We'll reach out to this number within 24 hrs