NCT02618031

Brief 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 extended time window for treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2016

Typical duration for phase_1

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 1, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

February 5, 2020

Completed
Last Updated

February 5, 2020

Status Verified

January 1, 2020

Enrollment Period

2.5 years

First QC Date

November 26, 2015

Results QC Date

July 2, 2019

Last Update Submit

January 23, 2020

Conditions

Acute StrokeBrain IschemiaIschemic Stroke

Keywords

capillary index scoreacute ischemic strokecollateral circulationcerebral ischemiadiagnostic imaging

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Complication Rate Between Favorable CIS Group Versus Poor CIS Group

    1 day - 1 week

  • Modified Rankin Score (mRS) Between Favorable CIS With Good Revascularization Versus Poor CIS With Good Revascularization.

    90 days

Study Arms (2)

Favorable CIS

OTHER

Patients with a favorable CIS (fCIS) will receive endovascular treatment (EVT) and medical treatment consistent with national guidelines.

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.

Procedure: Endovascular Treatment (EVT)

Interventions

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.

Also known as: Intra-arterial Treatment (IAT)
Favorable CISPoor CIS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

WellStar Atlanta Medical System

Atlanta, Georgia, 30312, United States

Location

New York University Langone Medical Center

New York, New York, 10016, United States

Location

Rochester General Hospital

Rochester, New York, 14621, United States

Location

University of North Carolina Hospital

Chapel Hill, North Carolina, 27514, United States

Location

Akron General Medical Center

Akron, Ohio, 44307, United States

Location

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Location

Related Publications (5)

  • 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.

    PMID: 25954243BACKGROUND

  • 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.

    PMID: 26082751BACKGROUND

  • 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.

    PMID: 25953374BACKGROUND

  • 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.

    PMID: 24851874BACKGROUND

  • 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.

    PMID: 22266703BACKGROUND

MeSH Terms

Conditions

StrokeBrain IschemiaIschemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Limitations and Caveats

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.

Results Point of Contact

Title
John Elias
Organization
Cleveland Clinic Akron General
eliasj@ccf.org
330-344-6176

Study Officials

  • Firas Al-Ali, MD

    Cleveland Clinic Akron General

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The participants and investigators evaluating 90 day outcomes will be blinded to the group.
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Patients will be assigned to one of two groups based on the outcome of diagnostic evaluation. Treatment will be identical for the two groups.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Neurointerventionalist

Study Record Dates

First Submitted

November 26, 2015

First Posted

December 1, 2015

Study Start

March 1, 2016

Primary Completion

August 31, 2018

Study Completion

December 31, 2018

Last Updated

February 5, 2020

Results First Posted

February 5, 2020

Record last verified: 2020-01

Locations

US(6)