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| Name | Class |
|---|---|
| Stryker Neurovascular | INDUSTRY |
| Rochester General Hospital | OTHER |
| University of Vermont Medical Center | OTHER |
| University of North Carolina, Chapel Hill |
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This study seeks to investigate the capillary index score (CIS) to further improve patient selection of endovascular treatment (EVT) in acute ischemic stroke (AIS).
The hypothesis or idea being tested:
Patients with favorable CIS who are successfully revascularized with EVT can have successful outcomes with an extended time window for treatment.
This study is trying to look at how the well-being of the patient following treatment is influenced by peripheral blood supply (collateral flow) to the area lacking primary blood flow due to the clot. Treatment of AIS includes EVT and medical treatment. EVT is typically not offered to patients after 6 hours of the onset of symptoms. The current study is based on the belief that patients can be successfully treated with the EVT up to 8 hours, as long as they have good peripheral blood flow (collateral flow) to the area of tissue blocked of the primary blood supply.
The study will evaluate the ability of the capillar index score (CIS) to identify patients who can be successfully treated with EVT. The CIS quantifies blood supply to the ischemic area from peripheral vessels (collateral flow) based on diagnostic cerebral angiogram. Patients are graded on a scale from 0-3, with 0 and 1 considered a poor CIS (pCIS) and 2 and 3 considered a favorable CIS (fCIS). All patients will be treated with EVT and medical treatment consistent with national guidelines.
The primary endpoint is the clinical outcome at 90 days between fCIS group versus pCIS group. The secondary endpoint is the influence of successful revascularization on outcomes for patients with fCIS or pCIS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Favorable CIS | Other | Patients with a favorable CIS (fCIS) will receive endovascular treatment (EVT) and medical treatment consistent with national guidelines. |
|
| Poor CIS | Experimental | Patients with a poor CIS (pCIS) will receive endovascular treatment (EVT) and medical treatment consistent with national guidelines. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovascular Treatment (EVT) | Procedure | EVT is an endovascular procedure in which a catheter is inserted into an artery and directed to the site of the blocked blood vessel in the brain. The clot is removed using a mechanical device with or without an injection of tPA (tissue plasminogen activator) directly at the site of the clot. The protocol calls for use of the Trevo stent retriever (Stryker Neurovascular) for the first pass of clot removal. |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Rankin Score (mRS) Between Favorable CIS Group Versus Poor CIS Group. | The mRS Score ranges from 0-6 and describes the degree of disability or dependence after a stroke. The grades are no symptoms (0), no significant disability (1), slight disability (2), moderate disability (3), moderately severe disability (4), severe disability (5), and death (6). | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Complication Rate Between Favorable CIS Group Versus Poor CIS Group | Complication : Clinically relevant intracranial hemorrhage and vasogenic edema as defined by parenchymal hematoma (PH) 1 or 2 | 1 day - 1 week |
| Modified Rankin Score (mRS) Between Favorable CIS With Good Revascularization Versus Poor CIS With Good Revascularization. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Firas Al-Ali, MD | Cleveland Clinic Akron General | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WellStar Atlanta Medical System | Atlanta | Georgia | 30312 | United States | ||
| New York University Langone Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25954243 | Background | Al-Ali F, Elias JJ, Filipkowski DE, Faber JE. Acute ischemic stroke treatment, part 1: patient selection "the 50% barrier and the capillary index score". Front Neurol. 2015 Apr 22;6:83. doi: 10.3389/fneur.2015.00083. eCollection 2015. | |
| 26082751 | Background | Al-Ali F, Elias JJ, Filipkowski DE. Acute Ischemic Stroke Treatment, Part 2: Treatment "Roles of Capillary Index Score, Revascularization and Time". Front Neurol. 2015 Jun 1;6:117. doi: 10.3389/fneur.2015.00117. eCollection 2015. |
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Final assignment to a group was not determined until the diagnostic cerebral angiograms were evaluated by the core lab at the end of the study to quantify the Capillary Index Score for each subject. Preliminary assessment of group was determined by the operators at the time of treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Favorable CIS | Patients with a favorable CIS (fCIS) will receive endovascular treatment (EVT) and medical treatment consistent with national guidelines. Endovascular Treatment (EVT): EVT is an endovascular procedure in which a catheter is inserted into an artery and directed to the site of the blocked blood vessel in the brain. The clot is removed using a mechanical device with or without an injection of tPA directly at the site of the clot. |
| FG001 | Poor CIS | Patients with a poor CIS (pCIS) will receive endovascular treatment (EVT) and medical treatment consistent with national guidelines. Endovascular Treatment (EVT): EVT is an endovascular procedure in which a catheter is inserted into an artery and directed to the site of the blocked blood vessel in the brain. The clot is removed using a mechanical device with or without an injection of tPA directly at the site of the clot. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The core lab was unable to evaluate the CIS from the saved diagnostic cerebral angiograms for some of the enrolled subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | Favorable CIS | Patients with a favorable Capillary Index Score (fCIS) will receive endovascular treatment (EVT) and medical treatment consistent with national guidelines. Endovascular Treatment (EVT): EVT is an endovascular procedure in which a catheter is inserted into an artery and directed to the site of the blocked blood vessel in the brain. The clot is removed using a mechanical device with or without an injection of tissue plasminogen activator (tPA) directly at the site of the clot. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Modified Rankin Score (mRS) Between Favorable CIS Group Versus Poor CIS Group. | The mRS Score ranges from 0-6 and describes the degree of disability or dependence after a stroke. The grades are no symptoms (0), no significant disability (1), slight disability (2), moderate disability (3), moderately severe disability (4), severe disability (5), and death (6). | A good outcome is defined as mRS 0-2 | Posted | Count of Participants | Participants | 90 days |
|
3 months
All subjects in the study are considered at risk for death due to the nature of the stroke.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Favorable CIS | Patients with a favorable CIS (fCIS) will receive endovascular treatment (EVT) and medical treatment consistent with national guidelines. Endovascular Treatment (EVT): EVT is an endovascular procedure in which a catheter is inserted into an artery and directed to the site of the blocked blood vessel in the brain. The clot is removed using a mechanical device with or without an injection of tPA directly at the site of the clot. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hemorrhage | Vascular disorders | Non-systematic Assessment | Subarachnoid hemorrhage related to vessel perforation during treatment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| radiation | General disorders | Non-systematic Assessment | For three subjects at one site, the consent form did not adequately represent use of additional angiograms (100 milligrays of radiation) and contrast dye (20 mL) above standard of care for the site. |
The sample size was limited by funding available to support the trial. The assignment of Capillary Index Score (CIS) by an independent core lab at the end of the trial led to a lower number of subjects in the poor CIS group than planned.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Elias | Cleveland Clinic Akron General | 330-344-6176 | eliasj@ccf.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 30, 2018 | May 6, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D002545 | Brain Ischemia |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| OTHER |
| NYU Langone Health | OTHER |
| WellStar Health System | OTHER |
Patients will be assigned to one of two groups based on the outcome of diagnostic evaluation. Treatment will be identical for the two groups.
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The participants and investigators evaluating 90 day outcomes will be blinded to the group.
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|
Revascularization status will be classified as poor (mTICI = 0-2A) or good (mTICI = 2B, 3). Rate of good clinical outcomes between groups will be compared based on the combination of CIS and revascularization status. Good outcome will be measured based on the modified Rankin scale score according to: 0: No symptoms
|
| 90 days |
| New York |
| New York |
| 10016 |
| United States |
| Rochester General Hospital | Rochester | New York | 14621 | United States |
| University of North Carolina Hospital | Chapel Hill | North Carolina | 27514 | United States |
| Akron General Medical Center | Akron | Ohio | 44307 | United States |
| University of Vermont Medical Center | Burlington | Vermont | 05401 | United States |
| 25953374 | Background | Al-Ali F, Elias JJ, Tomsick TA, Liebeskind DS, Broderick JP; IMS Study Groups. Relative Influence of Capillary Index Score, Revascularization, and Time on Stroke Outcomes From the Interventional Management of Stroke III Trial. Stroke. 2015 Jun;46(6):1590-4. doi: 10.1161/STROKEAHA.115.009066. Epub 2015 May 7. |
| 24851874 | Background | Al-Ali F, Tomsick TA, Connors JJ 3rd, Gebel JM, Elias JJ, Markarian GZ, Al-Ali Z, Broderick JP. Capillary Index Score in the Interventional Management of Stroke trials I and II. Stroke. 2014 Jul;45(7):1999-2003. doi: 10.1161/STROKEAHA.114.005304. Epub 2014 May 22. |
| 22266703 | Background | Al-Ali F, Jefferson A, Barrow T, Cree T, Louis S, Luke K, Major K, Nemeth D, Smoker S, Walker S. The capillary index score: rethinking the acute ischemic stroke treatment algorithm. Results from the Borgess Medical Center Acute Ischemic Stroke Registry. J Neurointerv Surg. 2013 Mar;5(2):139-43. doi: 10.1136/neurintsurg-2011-010146. Epub 2012 Jan 19. |
| BG001 | Poor CIS | Patients with a poor Capillary Index Score (pCIS) will receive endovascular treatment (EVT) and medical treatment consistent with national guidelines. Endovascular Treatment (EVT): EVT is an endovascular procedure in which a catheter is inserted into an artery and directed to the site of the blocked blood vessel in the brain. The clot is removed using a mechanical device with or without an injection of tissue plasminogen activator (tPA) directly at the site of the clot. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| diabetes | Count of Participants | Participants |
|
| blood pressure | Mean | Standard Deviation | mm Hg |
|
| occlusion site | Count of Participants | Participants |
|
| ischemic site | Count of Participants | Participants |
|
| National Institutes of Health stroke scale | The National Institutes of Health Stroke Scale provides a quantitative measure of stroke-related neurologic deficit. The scale includes 11 categories, graded on ability of the patient. The score ranges from 0 to 42, with 0 indicating normal function. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Poor CIS | Patients with a poor CIS (pCIS) will receive endovascular treatment (EVT) and medical treatment consistent with national guidelines. Endovascular Treatment (EVT): EVT is an endovascular procedure in which a catheter is inserted into an artery and directed to the site of the blocked blood vessel in the brain. The clot is removed using a mechanical device with or without an injection of tPA directly at the site of the clot. |
|
|
| Secondary | Complication Rate Between Favorable CIS Group Versus Poor CIS Group | Complication : Clinically relevant intracranial hemorrhage and vasogenic edema as defined by parenchymal hematoma (PH) 1 or 2 | post-operative bleeding was not available for two subjects who died before a postoperative scan | Posted | Count of Participants | Participants | 1 day - 1 week |
|
|
|
| Secondary | Modified Rankin Score (mRS) Between Favorable CIS With Good Revascularization Versus Poor CIS With Good Revascularization. | Revascularization status will be classified as poor (mTICI = 0-2A) or good (mTICI = 2B, 3). Rate of good clinical outcomes between groups will be compared based on the combination of CIS and revascularization status. Good outcome will be measured based on the modified Rankin scale score according to: 0: No symptoms
| output = number of patients with a good outcome one patient was lost to follow up | Posted | Count of Participants | Participants | 90 days |
|
|
|
| 8 |
| 45 |
| 1 |
| 45 |
| 2 |
| 45 |
| EG001 | Poor CIS | Patients with a poor CIS (pCIS) will receive endovascular treatment (EVT) and medical treatment consistent with national guidelines. Endovascular Treatment (EVT): EVT is an endovascular procedure in which a catheter is inserted into an artery and directed to the site of the blocked blood vessel in the brain. The clot is removed using a mechanical device with or without an injection of tPA directly at the site of the clot. | 7 | 11 | 0 | 11 | 1 | 11 |
|
|
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Poor outcome |
|