Trial · NCT00359424
Interventional Management of Stroke (IMS) III Trial
NCT00359424, Phase 3, Terminated, Joseph Broderick; results first posted 2013-12-13
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ConductScience Library. Interventional Management of Stroke (IMS) III Trial. Trials, record NCT00359424. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00359424
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Interventional Management of Stroke (IMS) III Trial
- NCT number
- NCT00359424
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 656 participants, actual
- Lead sponsor
- Joseph Broderick
- Conditions
- Stroke
- Interventions
- IV rt-PA alone, endovascular therapy
- First posted
- 2006-08-02
- Last updated
- 2013-12-13
- Other registries' IDs
- eudract:2009-017454-12
- Results first posted
- 2013-12-13
- Limitations and caveats
The IMS III trial was stopped early because of futility, according to the prespecified rules. A limitation of our trial is that it did not compare the efficacy of the new stent retrievers with that of intravenous t-PA alone.
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2. | at 90 days post randomization | The modified Rankin Scale (mRS) runs from 0-6 running from perfect health without symptoms to death. 0 - No symptoms at all. 1 - No significant disability. Able to carry out all usual duties and activities. 2 - Slight disability. Unable to carry out all previous activities but able to look after own affairs without assistance. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to walk unassisted and unable to attend to own bodily needs without assistance. 5 - Severe disability. Bedridden, incontinent, and requires constant nursing care and attention. 6 - Dead. Persons with a Rankin of 0-2 are considered functionally independent. |
| Primary | Death Due to Any Cause | within 90 days post randomization | |
| Primary | Symptomatic Intracranial Hemorrhage | within the first 30 hours post IV rt-PA | Symptomatic Intracranial Hemorrhage- Symptomatic ICH is defined as an intracranial hemorrhage temporally related to a decline in neurological status as well as new or worsening neurologic symptoms in the judgment of the clinical investigator and which may warrant medical intervention. These events are identified via Adverse Event CRF submitted by the site |
| Secondary | Incidence of Parenchymal Type II (PH2) Hematomas | within 30 hours post IV rt-PA | a dense intracerebral hematoma involving more than 30% of the infarcted area with substantial space-occupying effect or any hemorrhagic area outside the infarcted area, determined via central read of the submitted CT scans. |
| Secondary | Asymptomatic Intracranial Hemorrhage | within 30 hours post IV rt-PA | Asymptomatic intracranial hemorrhage is defined as an intracranial hemorrhage without evidence of decline in neurological status or new or worsening neurologic symptoms in the judgment of the clinical investigator. These events are identified via Adverse Event CRF submitted by the site. |
| Secondary | National Institutes of Health Stroke Scale Score (NIHSS) >> Dichotomized 0-1 Versus 2 or Greater. | at 24 hours post randomization | The National Institutes of Health Stroke Scale (NIHSS), a serial measure of neurologic deficit, is a 42-point scale that \>\> quantifies neurologic deficits in 11 categories, with 0 indicating normal function without neurologic deficit and higher \>\> scores indicating greater severity of deficit. |
| Secondary | National Institutes of Health Stroke Scale Score (NIHSS) Dichotomized 0-1 Versus 2 or Greater. | at 90 days post randomization | The National Institutes of Health Stroke Scale (NIHSS), a serial measure of neurologic deficit, is a 42-point scale that quantifies neurologic deficits in 11 categories, with 0 indicating normal function without neurologic deficit and higher scores indicating greater severity of deficit. |
| Secondary | Barthel Index (BI) Dichotomized 0-90 Versus 95-100 | at 90 days post randomization | The Barthel Index (BI)is an ordinal scale used to measure a subject's performance in activities of daily living (ADL) in ten variables- feeding, transfer (bed to chair), grooming, toilet use, bathing, mobility on a level surface, stair use, dressing, bowels and bladder. It is an assessment of independence in ADL and is scored in increments of 5 points. The lowest possible score on the index is 0 which implies total dependence on others for ADL and the highest total score is 100 which indicate full independent in ADL. A higher score is associated with a greater likelihood of being able to live at home with a degree of independence. |
| Secondary | Trail Making Test Part A Time | 90 days post randomization | The Trail Making Test is a neuropsychological test of visual attention and task switching that is thought to be sensitive to the presence of cerebral dysfunction. It is a timed test consisting of two parts where the subject is asked to draw a "trail" made by connecting numbers in sequential order (part A) and then in part B the combination of numbers and letters. Scoring is calculated separately for Parts A and B but both scores are provided as the minutes and seconds it takes for the subject to complete each part. Normally, the entire test (A and B) can be completed in 5 to 10 minutes. |
| Secondary | Trail Making Test Part B Time | at 90 days post randomization | The Trail Making Test is a neuropsychological test of visual attention and task switching that is thought to be sensitive to the presence of cerebral dysfunction. It is a timed test consisting of two parts where the subject is asked to draw a "trail" made by connecting numbers in sequential order (part A) and then in part B the combination of numbers and letters. Scoring is calculated separately for Parts A and B but both scores are provided as the minutes and seconds it takes for the subject to complete each part. Normally, the entire test (A and B) can be completed in 5 to 10 minutes. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2. | at 90 days post randomization | The primary analysis was conducted according to intention to treat. All subjects were analyzed in the treatment group to which they were randomized. Subjects with missing mRS (n=9 in group two; n=4 in group one) or mRS assessed \<60 days or \>120 days post-randomization (n=10 in group two; n=4 in group one) are assigned an unfavorable outcome(mRS \>2) | participants | NUMBER |
| PRIMARY | Death Due to Any Cause | within 90 days post randomization | The intent-to-treat analysis includes all subjects who were randomized, and each subject analyzed according to the treatment group to which they were randomly assigned. Subjects who ended the study prior to 90 days post- randomization for a reason other than death (LTFU etc) (n=8 in group two; n=2 in group one) are assumed to be alive | participants | NUMBER |
| PRIMARY | Symptomatic Intracranial Hemorrhage | within the first 30 hours post IV rt-PA | The intent-to-treat analysis sample includes all subjects who are randomized, and each subject is analyzed according to the treatment group to which they were randomly assigned. | participants | NUMBER |
| SECONDARY | Incidence of Parenchymal Type II (PH2) Hematomas | within 30 hours post IV rt-PA | Subjects were excluded if a post-baseline CT scan was not obtained within 30 hours of randomization (i.e., participants who died, had care withdrawn at the request of the family, or underwent imaging after the 30-hour window). | participants | NUMBER |
| SECONDARY | Asymptomatic Intracranial Hemorrhage | within 30 hours post IV rt-PA | The intent-to-treat analysis sample includes all subjects who are randomized, and each subject is analyzed according to the treatment group to which they were randomly assigned. | participants | NUMBER |
| SECONDARY | National Institutes of Health Stroke Scale Score (NIHSS) >> Dichotomized 0-1 Versus 2 or Greater. | at 24 hours post randomization | The intent-to-treat analysis sample includes all subjects who are randomized, and each subject is analyzed according to the treatment group to which they were randomly assigned. Subjects with missing NIHSS and NIHSS measured \<18 hours or \>30 hours post-randomization are assigned an unfavorable outcome (NIHSS score\>1). | participants | NUMBER |
| SECONDARY | National Institutes of Health Stroke Scale Score (NIHSS) Dichotomized 0-1 Versus 2 or Greater. | at 90 days post randomization | The intent-to-treat analysis sample includes all subjects who are randomized, and each subject is analyzed according to the treatment group to which they were randomly assigned. Subjects with missing NIHSS and NIHSS measured \<60 days or \>120 days post-randomization are assigned an unfavorable outcome (NIHSS score\>1). | participants | NUMBER |
| SECONDARY | Barthel Index (BI) Dichotomized 0-90 Versus 95-100 | at 90 days post randomization | The intent-to-treat analysis sample includes all subjects who are randomized, and each subject is analyzed according to the treatment group to which they were randomly assigned. Subjects with missing BI and BI measured \<60 days or \>120 days post-randomization are assigned an unfavorable outcome (BI 0-90). | participants | NUMBER |
| SECONDARY | Trail Making Test Part A Time | 90 days post randomization | Participants were excluded if the Trail Making Test was not assessed or if they failed to complete Part A. | seconds | MEAN |
| SECONDARY | Trail Making Test Part B Time | at 90 days post randomization | Participants were excluded if the Trail Making Test was not assessed or if they failed to complete Part B. | seconds | MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2. | Endovascular Therapy | mRS 0-2 | 177 | participants | |
| Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2. | IV Rt-PA Alone | mRS 0-2 | 86 | participants | |
| Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2. | Endovascular Therapy | mRS 3-6 | 257 | participants | |
| Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2. | IV Rt-PA Alone | mRS 3-6 | 136 | participants | |
| Death Due to Any Cause | Endovascular Therapy | 83 | participants | ||
| Death Due to Any Cause | IV Rt-PA Alone | 48 | participants | ||
| Symptomatic Intracranial Hemorrhage | Endovascular Therapy | 27 | participants | ||
| Symptomatic Intracranial Hemorrhage | IV Rt-PA Alone | 13 | participants | ||
| Incidence of Parenchymal Type II (PH2) Hematomas | Endovascular Therapy | 25 | participants | ||
| Incidence of Parenchymal Type II (PH2) Hematomas | IV Rt-PA Alone | 13 | participants |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Endovascular Therapy | 434 | |
| Overall Study | STARTED | IV Rt-PA Alone | 222 | |
| Overall Study | 90 Day Follow up | Endovascular Therapy | 343 | |
| Overall Study | 90 Day Follow up | IV Rt-PA Alone | 172 | |
| Overall Study | 180 Day Follow up | Endovascular Therapy | 325 | |
| Overall Study | 180 Day Follow up | IV Rt-PA Alone | 167 | |
| Overall Study | 270 Day Follow up | Endovascular Therapy | 313 | |
| Overall Study | 270 Day Follow up | IV Rt-PA Alone | 159 | |
| Overall Study | COMPLETED | Endovascular Therapy | 304 | |
| Overall Study | COMPLETED | IV Rt-PA Alone | 155 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events1,762
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Endovascular | 39 | 434 | 41 |
| other | Anaemia | Blood and lymphatic system disorders | IV Only | 16 | 222 | 17 |
| other | Coagulopathy | Blood and lymphatic system disorders | Endovascular | 2 | 434 | 2 |
| other | Coagulopathy | Blood and lymphatic system disorders | IV Only | 0 | 222 | 0 |
| other | Haemorrhagic disorder | Blood and lymphatic system disorders | Endovascular | 1 | 434 | 1 |
| other | Haemorrhagic disorder | Blood and lymphatic system disorders | IV Only | 0 | 222 | 0 |
| other | Hilar lymphadenopathy | Blood and lymphatic system disorders | Endovascular | 1 | 434 | 1 |
| other | Hilar lymphadenopathy | Blood and lymphatic system disorders | IV Only | 0 | 222 | 0 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Endovascular | 2 | 434 | 2 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | IV Only | 1 | 222 | 1 |
1 to 10 of 1,762Source ClinicalTrials.gov
See all 1,762 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Endovascular | ||
| Total, all-cause mortality | IV Only | ||
| Total, other adverse events | Endovascular | 385 | 434 |
| Total, other adverse events | IV Only | 202 | 222 |
| Total, serious adverse events | Endovascular | 256 | 434 |
| Total, serious adverse events | IV Only | 126 | 222 |
Source ClinicalTrials.gov
Papers18
The papers the trial lists on ClinicalTrials.gov.
Grants2
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U01NS052220 | Interventional Management of Stroke Study (IMS III) | BRODERICK, JOSEPH PAUL | UNIVERSITY OF CINCINNATI | NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE | 2005 to 2012 | NIH RePORTER |
| U01NS054630 | Statistical and Data Coordinating Center for ALIAS and IMS 111 Trials | PALESCH, YUKO Y | MEDICAL UNIVERSITY OF SOUTH CAROLINA | NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE | 2005 to 2010 | NIH RePORTER |
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Endovascular Therapy vs IV Rt-PA Alone: Incidence of Parenchymal Type II (PH2) Hematomas | Trial comparisons |
| Endovascular Therapy vs IV Rt-PA Alone: Asymptomatic Intracranial Hemorrhage | Trial comparisons |
| Endovascular Therapy vs IV Rt-PA Alone: Symptomatic Intracranial Hemorrhage | Trial comparisons |
| Endovascular Therapy vs IV Rt-PA Alone: Death Due to Any Cause | Trial comparisons |
| Endovascular vs IV Only: serious adverse events | Trial comparisons |
Tests3
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Task Switching Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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Read this trial from software.
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