A Study of Survival and Outcome After Stroke

NCT01193569 | Completed

• 1 other identifier: CLP2818
• Study Type: observational
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to determine the natural history of acute ischemic stroke from large vessel thromboembolism in the brain. The target population is a stroke cohort with a known infarct volume who presents within 8 hours from symptom onset with a NIH Stroke Scale (NIHSS) score \>10 who are eligible for mechanical thrombectomy but without receiving the treatment. Functional outcome as defined by the modified Rankin Scale (mRS) of all enrolled patients will be followed for 90 days after the index event.

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with a modified Rankin score of 2 or less

  90 days after the procedure

Secondary Outcomes (3)

• NIHSS score of 0-1 or a 10 or more points improvement

  Discharge

• All cause mortality

  90 days post-procedure

• Incidents of symptomatic and asymptomatic intracranial hemorrhage

  90 days post-procedure

Study Arms (1)

Standard of Care

Standard of Care for stroke except mechanical therapy

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

Patients presenting with symptoms of acute ischemic stroke within 8 hours from symptom onset and with an imaging-defined large cerebral vessel occlusion and a known infarct volume will be enrolled and followed for 90-days.

You may qualify if:

• From 18 to 85 years of age
• Evidence of proximal anterior circulation large vessel occlusion (TIMI 0-1/TICI 0-1)from CT Angiography. Target vessel occlusion may include the supra-clinoid segment of the ICA through the M1 segment of the MCA.
• Presented with symptoms consistent with acute ischemic stroke within 8 hours of symptom onset. Patients who presented within 3 hours must be ineligible or refractory to IV rtPA therapy.
• At time of enrollment, neurological deficit resulting in an NIH Stroke Scale (NIHSS) score \> 10
• Known core infarct volume assessed by CTP, CTA or DWI scans

You may not qualify if:

• History of stroke in the past 3 months.
• Pre-existing neurological or psychiatric disease that could confound the study results such as a pre-stroke mRS score \>1
• Known severe allergy to contrast media
• Uncontrolled hypertension (defined as systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg)
• CT evidence of the following conditions before enrollment:
• Significant mass effect with midline shift
• Evidence of intracranial hemorrhage
• Treated with endovascular therapy for acute stroke
• Life expectancy was thought to be less than 90 days prior to stroke due to non-stroke illness
• Participation in another clinical investigation that could confound the evaluation of the study

Sponsors & Collaborators

• Penumbra Inc.: lead

Study Sites (1)

Acute Vascular Imaging Centre, John Radcliffe Hospital, University of Oxford

Oxford, OX3 9DU, United Kingdom

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

• Iris Q Grunwald, MD

  The John Radcliffe Hospital, Oxford, UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2010
• First Posted: September 2, 2010
• Study Start: September 1, 2010
• Primary Completion: December 22, 2016
• Study Completion: December 22, 2016
• Last Updated: April 12, 2018

Record last verified: 2018-04

Locations

GB (1)