Ignite Creation Date:
2024-07-17 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06472336
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-06-10
Brief Title:
IntraCranial Atherosclerosis Related Large-vessel Occlusion Treated With Urgent Stenting ICARUS
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
IntraCranial Atherosclerosis Related Large-vessel Occlusion Treated With Urgent Stenting - a Pragmatic International Multicentre Randomized Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this international multi-center randomized clinical trial is to compare two treatment options early intracranial stenting and continued stent-retriever or aspiration based endovascular treatment for stroke patients with a large vessel occlusion who experienced failure of recanalisation after initial treatment due to intracranial atherosclerosis
Detailed Description:
This clinical tiral focuses on comparing treatment options for patients with an acute ischemic stroke which is a significant cause of death and disability worldwide Currently endovascular treatment EVT is the gold standard for the removal of large blood clots in the brain arteries large vessel occlusion LVO but sometimes it fails to reopen blocked blood vessels especially when caused by an underlying intracranial atherosclerosis ICAD When restoring blood flow fails patients outcomes are much worse with more than 70 experiencing severe disability or death
One potential solution for these cases is intracranial stenting where a stent is permanently implanted in the affected blood vessel to restore blood flow to the brain This approach has shown promise in other conditions like myocardial infarction However there is an ongoing debate whether the benefits are offset by possibly higher bleeding risk and current guidelines dont provide clear recommendations on the use of intracranial stenting
Therefore this study aims to compare the clinical efficacy and safety of early intracranial stenting versus continued conventional EVT stent-retriever or aspiration based in LVO stroke patients who havent responded to conventional EVT due to ICAD
The results of this clinical trial will offer high quality clinical evidence to determine whether intracranial stenting provides benefits over conventional EVT for LVO stroke patients experiencing recanalisation failure due to ICAD
One potential solution for these cases is intracranial stenting where a stent is permanently implanted in the affected blood vessel to restore blood flow to the brain This approach has shown promise in other conditions like myocardial infarction However there is an ongoing debate whether the benefits are offset by possibly higher bleeding risk and current guidelines dont provide clear recommendations on the use of intracranial stenting
Therefore this study aims to compare the clinical efficacy and safety of early intracranial stenting versus continued conventional EVT stent-retriever or aspiration based in LVO stroke patients who havent responded to conventional EVT due to ICAD
The results of this clinical trial will offer high quality clinical evidence to determine whether intracranial stenting provides benefits over conventional EVT for LVO stroke patients experiencing recanalisation failure due to ICAD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None