NCT05947994

Brief Summary

Intracranial atherosclerotic disease (ICAD) is a high prevalent cause of stroke, especially in Asian population and can be categorized as either symptomatic (resulting in acute ischemic stroke) or asymptomatic. Treatment for patients who failed with optimal medical therapy (OMT) is still elucidating.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2022

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 9, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 17, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2024

Completed
Last Updated

July 8, 2024

Status Verified

July 1, 2024

Enrollment Period

2 years

First QC Date

July 9, 2023

Last Update Submit

July 3, 2024

Conditions

Intracranial AtherosclerosisStent StenosisIschemic Stroke

Keywords

Ischemic strokeIntracranial AtherosclerosisIntracranial stenting

Outcome Measures

Primary Outcomes (2)

  • Rate of the critical adverse events

    The critical adverse events: intracranial hemorrhage, new infarct

    After procedure within 24 hours

  • Rate of 1-year recurrent ischemic stroke

    Rate of 1-year recurrent ischemic stroke in the territory of the symptomatic intracranial artery

    During 1 year after procedure

Study Arms (1)

Optimal medical therapy failure

EXPERIMENTAL

Symptomatic ischemic stroke patients were treated with Credo® Stent

Procedure: Intracranial stenting with Credo® stent

Interventions

Intracranial stenting with Credo® stentPROCEDURE

Symptomatic ischemic stroke patients were treated with Credo® Stent

Optimal medical therapy failure

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Evidence of severe intracranial stenosis
  • Target intracranial artery ≥ 2 mm
  • Absence of intracranial hemorrhage
  • Procedure treated with the Credo stent (Acandis, Pforzheim, Germany)

You may not qualify if:

  • Premorbid modified Rankin Scale (mRS) score ≥ 2
  • Intracranial rescue stenting for acute ischemic stroke within 24 hours
  • Loss to follow-up after discharge
  • Systemic lupus erythematosus
  • More procedures at the same time

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Can Tho Stroke International Service General Hospital

Can Tho, 900000, Vietnam

Location

Related Publications (4)

  • 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

  • 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

  • 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: 36263574BACKGROUND

  • Le MT, Tran CC, Nguyen-Luu G, Ngo MT, Nguyen-Dao NH, Duong-Hoang L, Mai-Van M, Nguyen MD. Rescue stenting after the failure of intravenous thrombolysis and bridging thrombolysis: an initial Vietnamese report. Eur Rev Med Pharmacol Sci. 2022 Dec;26(24):9162-9169. doi: 10.26355/eurrev_202212_30667.

    PMID: 36591828BACKGROUND

MeSH Terms

Conditions

Intracranial ArteriosclerosisIschemic Stroke

Condition Hierarchy (Ancestors)

Intracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesStroke

Study Officials

  • Cuong C Tran, PhD

    Can Tho Stroke International Services General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 9, 2023

First Posted

July 17, 2023

Study Start

January 1, 2022

Primary Completion

December 31, 2023

Study Completion

April 20, 2024

Last Updated

July 8, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

VN(1)