Clinical trial NCT05947994: Elucidate Outcomes of Elective High-grade/Total Occlusion Intracranial Arteries Using Low-profile Self-expanding Stent
Official title: Elucidate Outcomes of Elective High-grade/Total Occlusion Intracranial Arteries Using Low-profile Self-expanding Stent
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intracranial Atherosclerosis
Stent Stenosis
Ischemic Stroke
Keywords: Ischemic stroke
Intracranial Atherosclerosis
Intracranial stenting
Lead sponsor: Can Tho Stroke International Services Hospital
Sponsor class: OTHER
Collaborators: name: Acandis GmbH
First posted: 2023-07-17
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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 (IS) in the low risk of periprocedural stroke or death. However, this conclusion has influenced the role of IS in the secondary prevention of ischemic stroke and recovery time for a long time because of the improper patient selection of this trial such as no evidence of medical failure, IS in case of moderate intracranial stenosis and IS in patients with transient ischemic attacks only. Recently, the Food and Drug Administration (FDA) mandated study about IS, the Wingspan Stent System Post Market Surveillance (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 Wingspan One Year Vascular Imaging Events and Neurologic Outcomes (WOVEN) study about Wingspan stent (Stryker, Kalamazoo, MI). 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 with Wingspan stent in the world and a paucity of evidence from the comprehensive stroke centers about other self-expanding stents, Credo stent (Acandis GmbH, Pforzheim, Germany), our purpose was to compare the periprocedural complication and rate of 1-year recurrent ischemic stroke associating to the IS between beyond 7 days from acute stage and the progressive ischemic stroke time.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Rate of the critical adverse events
timeFrame: After procedure within 24 hours
measure: Rate of 1-year recurrent ischemic stroke
timeFrame: During 1 year after procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Cần Thơ
country: Vietnam
facility: Can Tho Stroke International Service General Hospital
Study officials:
affiliation: Can Tho Stroke International Services General Hospital
name: Cuong C Tran, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: 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.