Intracranial Rescue Stenting for Acute Ischemic Stroke, Predictors of Outcomes
Primary Purpose
Ischemic Stroke, Thromboembolic Stroke
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
intracranial rescue stenting
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Stroke
Eligibility Criteria
Inclusion Criteria:
- Patients with acute ischemic stroke due to large vessel occlusion as confirmed by CT angiography or Magnetic resonance (MR) angiography.
- Baseline NIHSS >6.
- Presenting within the first 6 hours from onset of symptoms.
- First ever stroke or pre-stroke modified Rankin Score (mRS) ≤1.
Exclusion Criteria:
- Patients with intra cranial hemorrhage.
- Patients younger than 18 years.
- Patients with acute ischemic stroke due to small vessel disease or vasculitis.
- Patients with acute ischemic stroke due to occlusion of vessels of posterior circulation.
- Patients who refused to be included in the study.
- Patients with contraindications to intracranial stent placement (as total occlusion of artery).
Sites / Locations
Outcomes
Primary Outcome Measures
number of participants with good re-perfusion after successful rescue stenting
this may help in case selection for best outcomes of the procedure
Secondary Outcome Measures
Compare the clinical outcomes of participants with rescue stenting with those who received medical treatment.
Compare the radio-logical outcomes of participants with rescue stenting with those who received medical treatment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04987710
Brief Title
Intracranial Rescue Stenting for Acute Ischemic Stroke, Predictors of Outcomes
Official Title
Intracranial Rescue Stenting for Acute Ischemic Stroke, Predictors of Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2022 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The use of rescue intracranial stenting is thought to be associated with better outcomes than with patients received medical treatment only after failed thrombectomy as Reperfusion technique. This raised the questions about the factors that affect outcomes of rescue intracranial stenting angioplasty, so the best outcomes can be achieved.
Detailed Description
Mechanical Thrombectomy is the first line therapy in acute ischemic stroke due to large vessel occlusion. Recently, there is an increasing number of patients with failed re perfusion after mechanical thrombectomy, due to preexisting high degree of intracranial stenosis or failed mechanical thrombectomy. This is associated with poor clinical and functional outcome for the patients.
The percentage of patients with failed mechanical thrombectomy is as high as 40-45% of all patients with ischemic stroke due to large vessel occlusion.
This group is in need for rescue intracranial stenting to achieve re-canalization of the occluded vessel and restore perfusion.
The results demonstrated superiority of medical management over stenting with less complications and this had almost put the intracranial stenting to rest for years.
The main complication related to rescue stenting are ischemic complications especially thromboembolic events related to thrombus detachment, symptomatic intracerebral hemorrhage and re-stenosis of cerebral arteries after stenting.
Recently, the results of the Chinese Angioplasty and Stenting for Symptomatic Intracranial Severe Stenosis trial and the Wingspan Stent System Post Market Surveillance Study (WEAVE trial) showed that most of complications are related to peri-procedural techniques. This raise the interest again in the efficacy of intracranial stenting as treatment modality for selected patients.
The use of rescue intracranial stenting is thought to be associated with better outcomes than with patients received medical treatment only after failed thrombectomy as Reperfusion technique. This raised the questions about the factors that affect outcomes of rescue intracranial stenting angioplasty, so the best outcomes can be achieved.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke, Thromboembolic Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
intracranial rescue stenting
Intervention Description
use of intracranial rescue stenting as re-perfusion technique after failed thrombectomy
Primary Outcome Measure Information:
Title
number of participants with good re-perfusion after successful rescue stenting
Description
this may help in case selection for best outcomes of the procedure
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Compare the clinical outcomes of participants with rescue stenting with those who received medical treatment.
Time Frame
12 months
Title
Compare the radio-logical outcomes of participants with rescue stenting with those who received medical treatment.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with acute ischemic stroke due to large vessel occlusion as confirmed by CT angiography or Magnetic resonance (MR) angiography.
Baseline NIHSS >6.
Presenting within the first 6 hours from onset of symptoms.
First ever stroke or pre-stroke modified Rankin Score (mRS) ≤1.
Exclusion Criteria:
Patients with intra cranial hemorrhage.
Patients younger than 18 years.
Patients with acute ischemic stroke due to small vessel disease or vasculitis.
Patients with acute ischemic stroke due to occlusion of vessels of posterior circulation.
Patients who refused to be included in the study.
Patients with contraindications to intracranial stent placement (as total occlusion of artery).
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26061843
Citation
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Citation
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Intracranial Rescue Stenting for Acute Ischemic Stroke, Predictors of Outcomes
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