Mild Acute Ischemic Stroke With Large Vessel Occlusion (MISTWAVE)

NCT03731351 | Completed

• 1 other identifier: 16-685
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

Stroke remains the leading cause of disability in the United States. An estimated 40-50% of all ischemic strokes are caused by large-vessel occlusion of a major cerebral artery (LVO). However, in some cases, the occlusion results in mild symptoms, at least initially, and these patients frequently do not receive any treatment. These strokes, however, may result in unfavorable long-term outcomes despite relatively benign initial course. Recent large randomized studies in patients with severe stroke symptoms and associated LVO showed efficacy and safety of endovascular mechanical thrombectomy, but patients with mild symptoms were not specifically addressed. Based on the investigators' own data and limited evidence in the literature, the investigators propose that early mechanical thrombectomy in patients with LVO associated with mild stroke symptoms (defined as NIHSS ≤ 5) is safe, and results in favorable long-term patient outcomes. The objective of this prospective pilot study is to assess the safety and outcomes of mechanical thrombectomy in patients presenting with acute ischemic stroke due to a large vessel occlusion in the anterior or posterior circulation under 24 hours with mild symptoms (NIHSS ≤ 5).

Conditions

Acute Ischemic Stroke

Keywords

Large Vessel Occlusion; mechanical thrombectomy; acute ischemic stroke

Outcome Measures

Primary Outcomes (2)

• Rate of symptomatic cerebral hemorrhage (ECASS definition)

  European Cooperative Acute Stroke Study (ECASS) classification: hemorrhagic infarct type 1 (HI1): small petechiae along the periphery of the infarct; hemorrhagic infarct type 2 (HI2): confluent petechiae within the infarcted area without a space-occupying effect; parenchymal hematoma type 1 (PH1): bleeding \</= 30% of the infarcted area with a mild space-occupying effect. parenchymal hematoma type 2 (PH2): bleeding \> 30% of the infarcted area with a significant space-occupying effect

  Within 24 hours of intervention

• Number of patients with a change in NIHSS by ≥ 4 points compared to enrollment NIHSS

  National Health Institute Stroke Scale (NIHSS): stroke symptom severity scale with a range of 0-42. Higher score means more severe stroke symptoms.

  Within 72 hours of intervention, or during hospitalization

Secondary Outcomes (6)

• Rate of successful angiographic recanalization grade TICI 2B or TICI 3 in the interventional arm

  On the day of index procedure (Day 0). This will be assessed on the last angiographic run that is performed during the index intervention for the patient's stroke

• Global disability assessment via modified Rankin Score (mRS) in all patients

  On the 1 day of discharge from hospitalization for the initial stroke event.

• Final infarct volume on CT or MRI, change of infarct volume on CT or MRI, and CTA collateral scores

  Repeat imaging within 2-5 days after event

• Residual stroke symptom severity assessment via National Health Institute Stroke Scale (NIHSS) in all patients

  On the 1 day of discharge from hospitalization for the initial stroke event.

• Global disability assessment via modified Rankin Score (mRS) in all patients

  30 days after procedure

Interventions

Mechanical Thrombectomy PROCEDURE

Acute Ischemic Stroke patient with Large Vessel Occlusion and NIHSS less than or equal to 5 will have a standard of care mechanical thrombectomy. Mechanical thrombectomy is a treatment for stroke that removes clots that block large blood vessels. Some patients may be candidates for this procedure using an angiogram or a catheterization and a device that grabs clots and removes them, to reestablish blood flow to the brain.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Males and females between 18-85 that present with acute ischemic strokes with large vessel occlusions and NIHSS\<6.

You may qualify if:

• Age 18 - 85.
• Clinical signs consistent with acute ischemic stroke.
• No prestroke functional dependence (prestroke Modified Rankin Score ≤ 1).
• NIHSS \<6 at the time of enrollment.
• Consent obtained within 24 hours from last known well.
• Thrombolysis in Cerebral Infarction (TICI) 0-1 flow in
• The M1 or M2 segment of the MCA, or carotid terminus confirmed by CT or MR angiography; or
• The basilar artery.
• Subject can be treated within 1 hours (60 minutes) from pre-procedure CT or MRI to groin puncture.
• CT or MRI-DWI ASPECT Score of \> 6 in the anterior circulation, or posterior circulation ASPECT Score (pc-ASPECTS) of \> 7.36
• Subject is willing to conduct protocol-required follow-up visits.
• Subject or subject's legally authorized representative has signed and dated an Informed Consent Form.
• NB: Patient can be enrolled regardless of whether the patient received IV t-PA. However, the decision for administration of IV t-PA must be made before enrolling into the study.

You may not qualify if:

• Female who is pregnant or lactating or has a positive pregnancy test at time of admission.
• Known serious sensitivity to radiographic contrast agents.
• Subject with a pre-existing neurological or psychiatric disease that would confound the neurological and functional evaluations. Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of hemorrhage on presentation.
• CT or MRI ASPECT score of ≤6 in the anterior circulation, or pc-ASPECTS of ≤7.
• CT or MRI evidence of mass effect or intra-cranial tumor (except small meningioma).
• Current participation in another investigation drug or device treatment study.
• Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency.
• Warfarin therapy with INR greater than 1.7.
• Low molecular Weight Heparins, Heparin, Factor Xa inhibitors or direct thrombin inhibitors as full dose within the last 48 hours from screening and must have a normal partial thromboplastin time (PTT) to be eligible.
• Baseline lab values: glucose \< 50 mg/dL or \> 400 mg/dL, platelets \< 100,000 or Hct \< 25.
• Renal Failure as defined by a serum creatinine \> 2.0 or Glomerular Filtration Rate \[GFR\]\< 30.
• Life expectancy of less than 90 days.
• Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT or MRI scan is normal.
• Presumed septic embolus, or suspicion of bacterial endocarditis.
• Preprocedural or intraprocedural diagnosis of an unexpected vascular lesion or condition that may require additional, non-standard thrombectomy endovascular procedure(s), such as stenting, angioplasty or other treatment, and pose an additional or elevated risk. Such conditions, listed below, exclude or invalidate enrollment in the study:

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (2)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Gabor Toth, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vascular and Interventional Neurologist

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: November 6, 2018
• Study Start: August 3, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: December 12, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)