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Completed

NCT Number: NCT02618031

The Capillary Index Score Trial

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.

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Key information

Conditions

Acute Stroke Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

WellStar Atlanta Medical System, Atlanta, Georgia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: Intra-arterial Treatment (IAT)

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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

  2. 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

    • 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

Sponsors and collaborators

Lead sponsor

Firas Al-Ali

Other

Collaborators

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

Registry information

Official study title

The Capillary Index Score Trial: Phase I

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 1, 2015
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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