NCT05063630

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2019

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 1, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2022

Completed
Last Updated

October 1, 2021

Status Verified

September 1, 2021

Enrollment Period

2.5 years

First QC Date

September 15, 2021

Last Update Submit

September 21, 2021

Conditions

Intracranial ArteriosclerosisIschemic StrokeIntracranial Arterial DiseasesArterial Occlusive Diseases

Keywords

Dual antiplatelet therapyMRI 3 TeslaWEAVE trialWOVEN trial

Outcome Measures

Primary Outcomes (1)

  • 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.

    During 1 year after randomization.

Secondary Outcomes (2)

  • Death rate of the qualifying lesion in the territory of the symptomatic intracranial artery.

    During 1 year after randomization.

  • Rate of ischemic stroke recovery of the qualifying lesion in the territory of the symptomatic intracranial artery.

    During 3 months after randomization..

Study Arms (2)

Medical treatment plus intracranial stenting (MT plus IS)

EXPERIMENTAL

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.

Procedure: Medical treatment plus intracranial stenting

Medical treatment alone (MT)

ACTIVE COMPARATOR

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.

Drug: Medical treatment alone

Interventions

Medical treatment plus intracranial stentingPROCEDURE

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.

Also known as: MT plus IS
Medical treatment plus intracranial stenting (MT plus IS)
Medical treatment aloneDRUG

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.

Also known as: MT
Medical treatment alone (MT)

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Can Tho SIS Hospital

Can Tho, 900000, Vietnam

RECRUITING

Related Publications (5)

  • 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.

    PMID: 21899409BACKGROUND

  • 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.

    PMID: 31125298BACKGROUND

  • 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.

    PMID: 32561658BACKGROUND

  • 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.

    PMID: 25803346BACKGROUND

  • 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.

    PMID: 31422789BACKGROUND

MeSH Terms

Conditions

Intracranial ArteriosclerosisIschemic StrokeIntracranial Arterial DiseasesArterial Occlusive Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArteriosclerosisVascular DiseasesCardiovascular DiseasesStroke

Study Officials

  • Cuong Tran Chi, Doctor

    Can Tho SIS Hospital

    STUDY CHAIR

Central Study Contacts

Cuong Tran Chi, Doctor

CONTACT

+84886559911drcuongtran@dotquy.vn

Can Tho SIS Hospital

CONTACT

18001115cskh@dotquy.vn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director - Doctor

Study Record Dates

First Submitted

September 15, 2021

First Posted

October 1, 2021

Study Start

May 1, 2019

Primary Completion

October 31, 2021

Study Completion

May 24, 2022

Last Updated

October 1, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

VN(1)