Credo Stent in the Symptomatic Intracranial Stenosis (CRESIS)

• ClinicalTrials.gov Identifier: NCT05947994
• Recruitment Status: Recruiting
• First Posted: July 17, 2023
• Last Update Posted: July 18, 2023
• Sponsor: Can Tho Stroke International Services Hospital
• Collaborator: Acandis GmbH
• Information provided by (Responsible Party): Dr. Cuong Tran Chi, Can Tho Stroke International Services Hospital

Study Description

Brief Summary:

In the symptomatic ischemic stroke, the decision-making of medical treatment plus intracranial stenting (IS) has been more and more popular, especially in patients with intracranial large severe stenosis or occlusive artery. Nonetheless, there were few evidences evaluating the comprehensive information of the other self-expanding stent relating IS procedure after positive results of the Wingspan Stent System Post Market Surveillance (WEAVE) trial and Wingspan One Year Vascular Imaging Events and Neurologic Outcomes (WOVEN) study about Wingspan stent. The aim of our study was to investigate whether IS with Credo stent would improve the adverse events during 1-year follow-up.

Condition or disease	Intervention/treatment	Phase
Intracranial Atherosclerosis; Stent Stenosis; Ischemic Stroke	Procedure: Intracranial stenting; Device: Credo® Stent	Not Applicable

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, 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 WOVEN study. 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 (Stryker, Kalamazoo, MI) 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 evaluate the periprocedural events associating to the IS.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 150 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: CREdo Stent in the Symptomatic Intracranial Stenosis
• Actual Study Start Date: September 1, 2021
• Estimated Primary Completion Date: October 1, 2024
• Estimated Study Completion Date: October 1, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intracranial stenting with Credo® Stent; Symptomatic ischemic stroke patients were treated with Credo® Stent	Procedure: Intracranial stenting; Symptomatic ischemic stroke patients were treated with Credo® Stent; Device: Credo® Stent; A self-expanding stent is used intracranial stenting

Outcome Measures

Primary Outcome Measures :

1. Rate of stroke of the qualifying lesion in the territory of the symptomatic intracranial artery [ Time Frame: During 1 year after procedure ]
   Stroke: new infarcts, intracranial hemorrhage, subarachnoid hemorrhage
2. Rate of death of the qualifying lesion in the territory of the symptomatic intracranial artery [ Time Frame: During 1 year after procedure ]
   Rate of death of the qualifying lesion in the territory of the symptomatic intracranial artery

Secondary Outcome Measures :

1. Rate of recurrent ischemic stroke of the qualifying lesion in the territory of the symptomatic intracranial artery. [ Time Frame: During 1 year after procedure ]
   Rate of recurrent ischemic stroke of the qualifying lesion in the territory of the symptomatic intracranial artery.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Contacts

Contact: Cuong C Tran, PhD; +84886559911; drcuongtran@dotquy.vn

Contact: Thang M Le, MD; +84948819808; drthangle@dotquy.vn

Locations

Vietnam

Can Tho Stroke International Service General Hospital; Recruiting

Cần Thơ, Vietnam, 900000

Contact: Thang M Le, MD +84948819808 drthangle@dotquy.vn

Principal Investigator: Cuong C Tran, PhD

Sponsors and Collaborators

Can Tho Stroke International Services Hospital

Acandis GmbH

Investigators

• Principal Investigator: Cuong C Tran, PhD; Can Tho Stroke International Services General Hospital

More Information

Publications:

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.

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.

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.

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.

• Responsible Party: Dr. Cuong Tran Chi, Director - Doctor, Can Tho Stroke International Services Hospital
• ClinicalTrials.gov Identifier: NCT05947994
• Other Study ID Numbers: CanTho S.I.S Hospital
• First Posted: July 17, 2023
• Last Update Posted: July 18, 2023
• Last Verified: July 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Cuong Tran Chi, Can Tho Stroke International Services Hospital:

Ischemic stroke; Intracranial Atherosclerosis; Intracranial stenting

Additional relevant MeSH terms:

Ischemic Stroke; Intracranial Arteriosclerosis; Atherosclerosis; Constriction, Pathologic; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Arteriosclerosis; Arterial Occlusive Diseases; Intracranial Arterial Diseases