Elucidate Outcomes of Elective High-grade/Total Occlusion Intracranial Arteries Using Low-profile Self-expanding Stent (CRESIS)

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.

Study Overview

• Status: Completed
• Conditions: Ischemic Stroke; Stent Stenosis; Intracranial Atherosclerosis
• Intervention / Treatment: Procedure: Intracranial stenting with Credo® stent

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.

• Study Type: Interventional
• Enrollment (Actual): 156
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Vietnam
  • Cần Thơ, Vietnam, 900000
    • Can Tho Stroke International Service General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Optimal medical therapy failure; Symptomatic ischemic stroke patients were treated with Credo® Stent	Procedure: Intracranial stenting with Credo® stent; Symptomatic ischemic stroke patients were treated with Credo® Stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Rate of the critical adverse events	The critical adverse events: intracranial hemorrhage, new infarct	After procedure within 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 procedure

Collaborators and Investigators

• Sponsor: Can Tho Stroke International Services Hospital
• Collaborators: Acandis GmbH
• Investigators: Principal Investigator: Cuong C Tran, PhD, Can Tho Stroke International Services General Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): April 20, 2024

Study Registration Dates

• First Submitted: July 9, 2023
• First Submitted That Met QC Criteria: July 9, 2023
• First Posted (Actual): July 17, 2023

Study Record Updates

• Last Update Posted (Actual): July 8, 2024
• Last Update Submitted That Met QC Criteria: July 3, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Ischemic stroke; Intracranial Atherosclerosis; Intracranial stenting
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Stroke; Intracranial Arterial Diseases; Ischemic Stroke; Atherosclerosis; Intracranial Arteriosclerosis
• Other Study ID Numbers: CRESIS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No