Interventional Management of Stroke (IMS) II Study
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|ClinicalTrials.gov Identifier: NCT00243906|
Recruitment Status : Completed
First Posted : October 25, 2005
Last Update Posted : July 25, 2012
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Drug: Recombinant tissue plasminogen activator Procedure: Low-intensity ultrasound||Phase 2|
The overall goal of Interventional Management of Stroke (IMS II) study is to refine thrombolytic therapy for patients with acute ischemic stroke who can be treated within three hours of stroke onset.
This multi-center, non-randomized pilot study will provide preliminary data about the benefits and risks of combined intravenous (IV) and intra-arterial (IA) recombinant tissue plasminogen activator (rtPA) and low-intensity ultrasound energy in ischemic stroke patients with baseline NIHSSS >/= 10 in whom intravenous treatment can be started within three hours of stroke onset. rt-PA is a thrombolytic, clot-dissolving drug.
The primary objectives for the study are to obtain reliable estimates of the effectiveness and safety of a treatment approach combining IV/IA rt-PA and ultrasound for stroke patients; and to determine if the estimated effectiveness of combined IV/IA rt-PA at 3 months—as compared to the 3 month outcome of placebo-treated patients in the NINDS rt-PA Stroke Trial—warrants proceeding to a large, phase III randomized trial.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||81 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Interventional Management of Stroke (IMS) II Study|
|Study Start Date :||January 2003|
|Actual Primary Completion Date :||May 2006|
|Actual Study Completion Date :||May 2007|
- Drug: Recombinant tissue plasminogen activator
Low-dose IV rt-PA (0.6 mg/kg) followed by delivery of additional IA rt-PA (up to 22 mg).
- Procedure: Low-intensity ultrasound
Delivery of additional IA rt-PA (up to 22 mg) in the setting of low-energy ultrasound via the EKOS microinfusion catheter at the site of IA occlusion in acute ischemic stroke patients with large strokes (NIHSS >/= 10) treated within 3 hours of symptoms onset.
- Primary Safety Endpoint [ Time Frame: 36 hours after completion of rt-PA infusion ]Development of intracerebral hematoma or hemorrhagic infarction with clinical deterioration likely to result in permanent disability or death, or other severe systemic bleeding complications such as groin hematoma, retroperitoneal hematoma, or gastrointestinal bleeding requiring transfusion of 3 units of blood replacement or major surgical intervention.
- Primary Angiographic Outcome [ Time Frame: 60 minutes after start of IA therapy ]The primary revascularization end point was complete (arterial occlusive lesion III) recanalization of the targeted arterial occlusion at 60 minutes after the start of IA rt-PA and ultrasound therapy,
- Primary Outcome Measure [ Time Frame: 3 months following treatment ]modified Rankin Score of 0 or 1
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00243906
|United States, Ohio|
|University of Cincinnati|
|Cincinnati, Ohio, United States, 45267|
|Principal Investigator:||Joseph P. Broderick, MD||University of Cincinnati|
|Principal Investigator:||Thomas A. Tomsick, MD||University of Cincinnati|