Credo Stent in the Symptomatic Intracranial Stenosis (CRESIS)
Primary Purpose
Intracranial Atherosclerosis, Stent Stenosis, Ischemic Stroke
Status
Recruiting
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
Intracranial stenting
Credo® Stent
Sponsored by
About this trial
This is an interventional prevention trial for Intracranial Atherosclerosis focused on measuring Ischemic stroke, Intracranial Atherosclerosis, Intracranial stenting
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
Sites / Locations
- Can Tho Stroke International Service General HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intracranial stenting with Credo® Stent
Arm Description
Symptomatic ischemic stroke patients were treated with Credo® Stent
Outcomes
Primary Outcome Measures
Rate of stroke of the qualifying lesion in the territory of the symptomatic intracranial artery
Stroke: new infarcts, intracranial hemorrhage, subarachnoid hemorrhage
Rate of death of the qualifying lesion in the territory of the symptomatic intracranial artery
Rate of death of the qualifying lesion in the territory of the symptomatic intracranial artery
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05947994
First Posted
July 9, 2023
Last Updated
July 14, 2023
Sponsor
Can Tho Stroke International Services Hospital
Collaborators
Acandis GmbH
1. Study Identification
Unique Protocol Identification Number
NCT05947994
Brief Title
Credo Stent in the Symptomatic Intracranial Stenosis
Acronym
CRESIS
Official Title
CREdo Stent in the Symptomatic Intracranial Stenosis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Can Tho Stroke International Services Hospital
Collaborators
Acandis GmbH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Atherosclerosis, Stent Stenosis, Ischemic Stroke
Keywords
Ischemic stroke, Intracranial Atherosclerosis, Intracranial stenting
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intracranial stenting with Credo® Stent
Arm Type
Experimental
Arm Description
Symptomatic ischemic stroke patients were treated with Credo® Stent
Intervention Type
Procedure
Intervention Name(s)
Intracranial stenting
Intervention Description
Symptomatic ischemic stroke patients were treated with Credo® Stent
Intervention Type
Device
Intervention Name(s)
Credo® Stent
Intervention Description
A self-expanding stent is used intracranial stenting
Primary Outcome Measure Information:
Title
Rate of stroke of the qualifying lesion in the territory of the symptomatic intracranial artery
Description
Stroke: new infarcts, intracranial hemorrhage, subarachnoid hemorrhage
Time Frame
During 1 year after procedure
Title
Rate of death of the qualifying lesion in the territory of the symptomatic intracranial artery
Description
Rate of death of the qualifying lesion in the territory of the symptomatic intracranial artery
Time Frame
During 1 year after procedure
Secondary Outcome Measure Information:
Title
Rate of recurrent ischemic stroke of the qualifying lesion in the territory of the symptomatic intracranial artery.
Description
Rate of recurrent ischemic stroke of the qualifying lesion in the territory of the symptomatic intracranial artery.
Time Frame
During 1 year after procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cuong C Tran, PhD
Phone
+84886559911
Email
drcuongtran@dotquy.vn
First Name & Middle Initial & Last Name or Official Title & Degree
Thang M Le, MD
Phone
+84948819808
Email
drthangle@dotquy.vn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cuong C Tran, PhD
Organizational Affiliation
Can Tho Stroke International Services General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Can Tho Stroke International Service General Hospital
City
Cần Thơ
ZIP/Postal Code
900000
Country
Vietnam
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thang M Le, MD
Phone
+84948819808
Email
drthangle@dotquy.vn
First Name & Middle Initial & Last Name & Degree
Cuong C Tran, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32561658
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.
Results Reference
background
PubMed Identifier
31125298
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.
Results Reference
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PubMed Identifier
36263574
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.
Results Reference
background
PubMed Identifier
36591828
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.
Results Reference
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Credo Stent in the Symptomatic Intracranial Stenosis
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