Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00359424
Status:
TERMINATED
Last Update Posted:
2013-12-13
First Post:
2006-07-31
Brief Title:
Interventional Management of Stroke IMS III Trial
Sponsor:
Joseph Broderick
Organization:
University of Cincinnati
Study Overview
Official Title:
Interventional Management of Stroke Trial IMS III A Phase III Clinical Trial Examining Whether a Combined Intravenous IV and Intra-Arterial IA Approach to Recanalization is Superior to Standard IV Rt-PA Activase Alone
Status:
TERMINATED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
NINDSNIH-DSMB recommended halting trial due to futility no safety concerns
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMSIII
Brief Summary:
The purpose of this study is to compare two different treatment approaches to recanalization started within 3 hours of symptom onset-combined intravenous IV and endovascular therapy and standard intravenous IV rt-PA alone
Detailed Description:
Stroke remains a major cause of death and disability Acute thrombolytic therapy offers the potential to achieve early recanalization reopening of blocked arteries save tissues and improve outcome Currently intravenous IV recombinant tissue plasminogen activator rt-PA is the only approved acute stroke therapy IV rt-PA is an effective therapy for acute ischemic stroke but has substantial limitations when used alone to open blocked arteries The Interventional Management of Stroke IMS III Trial is a multi-center study that will compare two different treatment approaches for restoring blood flow to the brain One approach giving the clot-dissolving drug rt-PA is already FDA-approved when given through a vein IV This treatment will be compared to a new approach giving rt-PA at a lower dose first through IV in the arm and then if a blood clot in the brain artery is found through a small tube or catheter at the site of the blood clot intra-arterial or IA to see which is better Both approaches must be initiated within three hours of stroke onset
The primary goal of this trial is to determine if individuals with ischemic stroke treated with rt-PA using an endovascular therapy approach to recanalization started within 3 hours of onset are more likely to have a better outcome than individuals treated with standard IV rt-PA alone While information on device use was collected individual device performance was not a primary outcome
Nine hundred participants with moderate to severe ischemic stroke will be enrolled at more than 50 centers in the United States Canada Australia and Europe
Subjects will be randomized in a 21 ratio to receive endovascular therapy or IV only with adjustment for clinical site and NIHSSS strata If enrolled under Amendment 5 or later both treatment groups will receive the standard approved therapy dose of rt-PA 09 mgkg 90 mg max administered intravenously over one hour The consent process and randomization can take place prior to or anytime up to forty minutes after the IV bolus dose If at the 40 minute time point no consent has been obtained or randomization has not been completed the patient will no longer be eligible for IMS III enrollment After consent the endovascular therapy group will then undergo immediate angiography If clot is not demonstrated no more treatment is administered
If clot is demonstrated the neurointerventionalist will then choose from currently available but trial defined endovascular therapy approaches choosing the treatment they feel will be most effective in attempting to reopen the blocked artery These approaches utilize local regulatory US FDA and IMS III Executive Committee approved devices for the intra-arterial infusion of investigational rt-PA using standard microcatheter or the EKOS Micro-Infusion Catheter in US or embolectomy devices including the Concentric Retriever Device the Penumbra System or the Solitaire FR Revascularization Device All devices must be used per the manufacturers instructions for use Endovascular therapy whether initially with the Merci Retriever EKOS Micro-Infusion Catheter Penumbra System Solitaire a future device or infusion of IA rt-PA via a standard microcatheter must be started within 5 hours and completed within 7 hours of symptom onset The maximum dose of IA rt-PA is 22mg maximum 2 to 4 mg bolus and infusion at a rate of 10 mghr Use of tandem devices ie EKOS Micro-Infusion Catheter Merci Retriever Penumbra System or Solitaire in a single case is a protocol violation Only standard microcatheter rt-PA infusion therapy may be administered following attempt with a device
The primary measure of benefit in this trial is the ability of the individual with stroke to live and function independently 3 months after the stroke This trial will also determine and compare the safety and cost effectiveness of the combined endovascular therapy to the standard IV rt-PA approach
Duration of the study for participants is approximately 12 months
The primary goal of this trial is to determine if individuals with ischemic stroke treated with rt-PA using an endovascular therapy approach to recanalization started within 3 hours of onset are more likely to have a better outcome than individuals treated with standard IV rt-PA alone While information on device use was collected individual device performance was not a primary outcome
Nine hundred participants with moderate to severe ischemic stroke will be enrolled at more than 50 centers in the United States Canada Australia and Europe
Subjects will be randomized in a 21 ratio to receive endovascular therapy or IV only with adjustment for clinical site and NIHSSS strata If enrolled under Amendment 5 or later both treatment groups will receive the standard approved therapy dose of rt-PA 09 mgkg 90 mg max administered intravenously over one hour The consent process and randomization can take place prior to or anytime up to forty minutes after the IV bolus dose If at the 40 minute time point no consent has been obtained or randomization has not been completed the patient will no longer be eligible for IMS III enrollment After consent the endovascular therapy group will then undergo immediate angiography If clot is not demonstrated no more treatment is administered
If clot is demonstrated the neurointerventionalist will then choose from currently available but trial defined endovascular therapy approaches choosing the treatment they feel will be most effective in attempting to reopen the blocked artery These approaches utilize local regulatory US FDA and IMS III Executive Committee approved devices for the intra-arterial infusion of investigational rt-PA using standard microcatheter or the EKOS Micro-Infusion Catheter in US or embolectomy devices including the Concentric Retriever Device the Penumbra System or the Solitaire FR Revascularization Device All devices must be used per the manufacturers instructions for use Endovascular therapy whether initially with the Merci Retriever EKOS Micro-Infusion Catheter Penumbra System Solitaire a future device or infusion of IA rt-PA via a standard microcatheter must be started within 5 hours and completed within 7 hours of symptom onset The maximum dose of IA rt-PA is 22mg maximum 2 to 4 mg bolus and infusion at a rate of 10 mghr Use of tandem devices ie EKOS Micro-Infusion Catheter Merci Retriever Penumbra System or Solitaire in a single case is a protocol violation Only standard microcatheter rt-PA infusion therapy may be administered following attempt with a device
The primary measure of benefit in this trial is the ability of the individual with stroke to live and function independently 3 months after the stroke This trial will also determine and compare the safety and cost effectiveness of the combined endovascular therapy to the standard IV rt-PA approach
Duration of the study for participants is approximately 12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01NS052220 | NIH | None | None |
| U01NS054630 | NIH | None | None |
| 2009-017454-12 | EUDRACT_NUMBER | None | httpsreporternihgovquickSearchU01NS054630 |