- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05947994
Credo Stent in the Symptomatic Intracranial Stenosis (CRESIS)
April 27, 2024 updated by: Dr. Cuong Tran Chi, Can Tho Stroke International Services Hospital
Credo Stent in the Symptomatic Intracranial Stenosis: an Initial Vietnamese Study
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.
Study Overview
Status
Completed
Intervention / Treatment
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)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Cuong C Tran, PhD
- Phone Number: +84886559911
- Email: drcuongtran@dotquy.vn
Study Contact Backup
- Name: Thang M Le, MD
- Phone Number: +84948819808
- Email: drthangle@dotquy.vn
Study Locations
-
-
-
Cần Thơ, Vietnam, 900000
- Can Tho Stroke International Service General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Beyond 7 days from acute ischemic stroke time
Symptomatic ischemic stroke patients were treated with Credo® Stent beyond 7 days from acute ischemic stroke
|
A self-expanding stent is used intracranial stenting
Symptomatic ischemic stroke patients were treated with Credo® Stent
|
Experimental: The progressive ischemic stroke time
Symptomatic ischemic stroke patients were treated with Credo® Stent in the progressive ischemic stroke
|
A self-expanding stent is used intracranial stenting
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 the periprocedural complication
Time Frame: After procedure within 24 hours
|
The periprocedural complication: large Infarct and intracranial hemorrhage
|
After procedure within 24 hours
|
Rate of 1-year recurrent ischemic stroke
Time Frame: During 1 year after procedure
|
Rate of 1-year recurrent ischemic stroke in the territory of the symptomatic intracranial artery
|
During 1 year after procedure
|
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.
Time Frame: During 1 year after procedure
|
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
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Cuong C Tran, PhD, Can Tho Stroke International Services General Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2021
Primary Completion (Actual)
February 29, 2024
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 (Estimated)
April 30, 2024
Last Update Submitted That Met QC Criteria
April 27, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Pathological Conditions, Anatomical
- Stroke
- Intracranial Arterial Diseases
- Ischemic Stroke
- Constriction, Pathologic
- 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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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