The Capillary Index Score Trial

Phase 1

Completed

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.

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Favorable CIS	Endovascular Treatment (EVT)	Patients with a favorable CIS (fCIS) will receive endovascular treatment (EVT) and medical treatment consistent with national guidelines.
Poor CIS	Endovascular Treatment (EVT)	Patients with a poor CIS (pCIS) will receive endovascular treatment (EVT) and medical treatment consistent with national guidelines.

Primary Outcome Measures

Name	Time	Method
Modified Rankin Score (mRS) Between Favorable CIS Group Versus Poor CIS Group.	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 Outcome Measures

Name	Time	Method
Complication Rate Between Favorable CIS Group Versus Poor CIS Group	1 day - 1 week	Complication : Clinically relevant intracranial hemorrhage and vasogenic edema as defined by parenchymal hematoma (PH) 1 or 2
Modified Rankin Score (mRS) Between Favorable CIS With Good Revascularization Versus Poor CIS With Good Revascularization.	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

Locations (6): New York University Langone Medical Center
🇺🇸
New York, New York, United States
University of North Carolina Hospital
🇺🇸
Chapel Hill, North Carolina, United States
WellStar Atlanta Medical System
🇺🇸
Atlanta, Georgia, United States
Akron General Medical Center
🇺🇸
Akron, Ohio, United States
Rochester General Hospital
🇺🇸
Rochester, New York, United States
University of Vermont Medical Center
🇺🇸
Burlington, Vermont, United States