The Capillary Index Score Trial

January 23, 2020 updated by: Firas Al-Ali

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.

Study Overview

Status

Completed

Conditions

Intervention / 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 Type

Interventional

Enrollment (Actual)

57

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30312
        • WellStar Atlanta Medical System
    • New York
      • New York, New York, United States, 10016
        • New York University Langone Medical Center
      • Rochester, New York, United States, 14621
        • Rochester General Hospital
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • University of North Carolina Hospital
    • Ohio
      • Akron, Ohio, United States, 44307
        • Akron General Medical Center
    • Vermont
      • Burlington, Vermont, United States, 05401
        • University of Vermont Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Anterior circulation acute ischemic stroke due to blockage of the intracranial internal carotid artery or middle cerebral artery (M1)
  2. Within 24 hours of onset of symptoms
  3. NIHSS Score is 8 or greater

Exclusion Criteria:

  1. Contra-indication for IAT found on initial CT
  2. Intracranial hemorrhage
  3. Stroke mimics (tumor, herpetic encephalitis, etc.)
  4. More than 1/3 hypodensity on non-enhanced head CT prior to intervention
  5. ASPECT Score less than 6
  6. Pre-existing disability defined as modified Rankin Scale (mRS) score more than 2
  7. Pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Favorable CIS
Patients with a favorable CIS (fCIS) will receive endovascular treatment (EVT) and medical treatment consistent with national guidelines.
Procedure: 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 (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.
Other Names:
  • Intra-arterial Treatment (IAT)
Experimental: Poor CIS
Patients with a poor CIS (pCIS) will receive endovascular treatment (EVT) and medical treatment consistent with national guidelines.
Procedure: 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 (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.
Other Names:
  • Intra-arterial Treatment (IAT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complication Rate Between Favorable CIS Group Versus Poor CIS Group
Time Frame: 1 day - 1 week
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.
Time Frame: 90 days

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

  1. No significant disability despite symptoms
  2. Slight disability
  3. Moderate disability
  4. Moderately severe disability
  5. Severe disability
  6. Dead A score of 0-2 is considered a good outcome
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Firas Al-Ali

Collaborators

NYU Langone Health
Stryker Neurovascular
University of North Carolina, Chapel Hill
University of Vermont Medical Center
Rochester General Hospital
WellStar Health System

Investigators

  • Principal Investigator: Firas Al-Ali, MD, Akron General Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

August 31, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

November 26, 2015

First Submitted That Met QC Criteria

November 30, 2015

First Posted (Estimate)

December 1, 2015

Study Record Updates

Last Update Posted (Actual)

February 5, 2020

Last Update Submitted That Met QC Criteria

January 23, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIS Trial

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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