Acute StrokePhase 1NCT02618031
The Capillary Index Score Trial
A Phase 1 study testing Endovascular Treatment (EVT) in people with Acute Stroke and Brain Ischemia, run by Firas Al-Ali at 6 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Stroke, Brain Ischemia, Ischemic Stroke
- What is being tested?
- Endovascular Treatment (EVT)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 6 sitesUnited States
- Study dates
- 1 Mar 2016to 31 Dec 2018
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Anterior circulation acute ischemic stroke due to blockage of the intracranial internal carotid artery or middle cerebral artery (M1)
- Within 24 hours of onset of symptoms
- NIHSS Score is 8 or greater
Who cannot join
- Contra-indication for IAT found on initial CT
- Intracranial hemorrhage
- Stroke mimics (tumor, herpetic encephalitis, etc.)
- More than 1/3 hypodensity on non-enhanced head CT prior to intervention
- ASPECT Score less than 6
- Pre-existing disability defined as modified Rankin Scale (mRS) score more than 2
- Pregnant women
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Akron General Medical Center
Akron, Ohio, 44307
WellStar Atlanta Medical System
Atlanta, Georgia, 30312
University of Vermont Medical Center
Burlington, Vermont, 05401
University of North Carolina Hospital
Chapel Hill, North Carolina, 27514
New York University Langone Medical Center
New York, New York, 10016
Rochester General Hospital
Rochester, New York, 14621
About this study
Official title: The Capillary Index Score Trial: Phase I
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.
Read the detailed description
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.
- Conditions
- Acute Stroke, Brain Ischemia, Ischemic Stroke
- Being tested
- Endovascular Treatment (EVT)
- Keywords
- capillary index score, acute ischemic stroke, collateral circulation, cerebral ischemia, diagnostic imaging
- Medical subject headings
- Stroke, Brain Ischemia, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular Treatment (EVT)Procedure or surgery
Also called Intra-arterial Treatment (IAT)
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.
| Study group | Role | What they receive |
|---|---|---|
| Favorable CIS | Other | Patients with a favorable CIS (fCIS) will receive endovascular treatment (EVT) and medical treatment consistent with national guidelines. Receives: Procedure: Endovascular Treatment (EVT) |
| Poor CIS | Experimental | Patients with a poor CIS (pCIS) will receive endovascular treatment (EVT) and medical treatment consistent with national guidelines. Receives: Procedure: Endovascular Treatment (EVT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 90 days
Secondary outcomes (2)
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
Measured: 1 day - 1 week
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
- No significant disability despite symptoms
- Slight disability
- Moderate disability
- Moderately severe disability
- Severe disability
- Dead A score of 0-2 is considered a good outcome
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study start1 Mar 2016
- Primary completion31 Aug 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be assigned to one of two groups based on the outcome of diagnostic evaluation. Treatment will be identical for the two groups.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Firas Al-Ali
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Neurovascular, Rochester General Hospital, University of Vermont Medical Center, University of North Carolina, Chapel Hill, NYU Langone Health, WellStar Health System
- Responsible party
- Sponsor-investigator, Firas Al-Ali, Cleveland Clinic Akron General
- Investigators
- Firas Al-Ali, MD, Principal investigator, Cleveland Clinic Akron General
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02618031
- Sponsor's protocol ID
- CIS Trial
- Status last verified
- Jan 2020
- First submitted
- 26 Nov 2015
- Last updated
- 5 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 25954243Al-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.
PubMed 26082751Al-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.
PubMed 25953374Al-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.
PubMed 24851874Al-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.
PubMed 22266703
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Capillary Index Score Trial: Phase I
- ClinicalTrials.gov ID
- NCT02618031
- Acronym / sponsor ID
- CIS Trial
- Conditions
- Acute Stroke, Brain Ischemia, Ischemic Stroke
- Keywords
- capillary index score, acute ischemic stroke, collateral circulation, cerebral ischemia, diagnostic imaging
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Firas Al-AliUniversity, hospital or other
- Collaborators
- Stryker Neurovascular, Rochester General Hospital, University of Vermont Medical Center, University of North Carolina, Chapel Hill, NYU Langone Health, WellStar Health System
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 1 Dec 2015 (estimated)
- Results
- Posted 5 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be assigned to one of two groups based on the outcome of diagnostic evaluation. Treatment will be identical for the two groups.
| Arm | Type | Receives |
|---|---|---|
| Favorable CIS | Other | Procedure: Endovascular Treatment (EVT)Patients with a favorable CIS (fCIS) will receive endovascular treatment (EVT) and medical treatment consistent with national guidelines. |
| Poor CIS | Experimental | Procedure: Endovascular Treatment (EVT)Patients with a poor CIS (pCIS) will receive endovascular treatment (EVT) and medical treatment consistent with national guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Anterior circulation acute ischemic stroke due to blockage of the intracranial internal carotid artery or middle cerebral artery (M1)
- Within 24 hours of onset of symptoms
- NIHSS Score is 8 or greater
Key exclusion criteria (7 listed)
- Contra-indication for IAT found on initial CT
- Intracranial hemorrhage
- Stroke mimics (tumor, herpetic encephalitis, etc.)
- More than 1/3 hypodensity on non-enhanced head CT prior to intervention
- ASPECT Score less than 6
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endovascular Treatment (EVT)Also: Intra-arterial Treatment (IAT)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. | Procedure or surgery | Favorable CIS, Poor CIS |
Primary outcome
Modified Rankin Score (mRS) Between Favorable CIS Group Versus Poor CIS Group.
Time frame: 90 days
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).
2 secondary outcomes
Complication Rate Between Favorable CIS Group Versus Poor CIS Group
Time frame: 1 day - 1 week
Modified Rankin Score (mRS) Between Favorable CIS With Good Revascularization Versus Poor CIS With Good Revascularization.
Time frame: 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25954243Al-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.
- Background: PubMed 26082751Al-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.
- Background: PubMed 25953374Al-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.
- Background: PubMed 24851874Al-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.
- Background: PubMed 22266703Al-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Firas Al-Ali, MD principal investigator
Cleveland Clinic Akron General
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Endovascular Treatment (EVT) in people with Acute Stroke and Brain Ischemia, run by Firas Al-Ali at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin Score (mRS) Between Favorable CIS Group Versus Poor CIS Group. (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02618031, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020; AzTrials last refreshed its copy on 30 Oct 2026.