Credo Stent in the Symptomatic Intracranial Stenosis

Ischemic Stroke Clinical Trial

— CRESIS  

Official title:

Credo Stent in the Symptomatic Intracranial Stenosis: an Initial Vietnamese Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05947994
• Other study ID #: CRESIS
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: April 20, 2024

Study information

• Verified date: April 2024
• Source: Can Tho Stroke International Services Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In the 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 were few evidences about times of intracranial stenting which compared beyond 7 days from acute ischemic stroke with the progressive ischemic stroke time. The purpose of this study was to compared the adverse events during 1-year follow-up of these two groups.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 20, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Constriction, Pathologic
• Intracranial Arteriosclerosis
• Intracranial Atherosclerosis
• Ischemic Stroke
• Stent Stenosis

Intervention

Procedure:
• Intracranial stenting with Credo® stent
Symptomatic ischemic stroke patients were treated with Credo® Stent

Device:
• Credo® Stent
A self-expanding stent is used intracranial stenting

Locations

Country	Name	City	State
Vietnam	Can Tho Stroke International Service General Hospital	C?n Tho

Sponsors (2)

Lead Sponsor	Collaborator
Can Tho Stroke International Services Hospital	Acandis GmbH

Country where clinical trial is conducted

Vietnam, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of the periprocedural complication	The periprocedural complication: large Infarct and intracranial hemorrhage	After procedure within 24 hours
Primary	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