ARISE: After 8 Hours Reperfusion in Ischemic Stroke Embolization

Not Applicable

Suspended

• Conditions: Ischemic Stroke
• Interventions: Device: mechanical thrombectomy

• Registration Number: NCT02533778
• Lead Sponsor: Abington Memorial Hospital

Brief Summary

A prospective pilot study to evaluate the recanalization and safety of mechanical thrombectomy through a cerebral angiogram in patients with stroke symptoms last seen normal between 8 - 24 hours.

Detailed Description

Ischemic stroke patients who are 8-24 hrs from symptom onset without prior mechanical or IV thrombolytic treatment and are screen with CT or MR perfusion imaging showing penumbra and infarction not \> 1/3rd the territory.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-14
• Study First Submitted QC: 2015-08-25
• Study First Posted: 2015-08-27
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-31
• Last Update Posted: 2017-08-02
• Primary Completion: 2018-07-01
• Study Completion: 2018-07-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Over 18 years last seen normal between 8 - 24 hours, without prior history of intravenous plasminogen activator (IV t-PA ) or
• mechanical thrombectomy Vessels - intracranial vertebral artery, basilar artery, intracranial ICA, ICA terminus bifurcation, MCA M1/M2, or
• ACA NIHSS ≥ 7 MRI DWI/PWI or
• CTA/P, which demonstrates an area of mismatch ≥ 2/3 rd
• Signed informed consent

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Exclusion Criteria

• creat >= 2
• NIHSS < 7
• Baseline mRS >= 2
• infarct > 1/3rd MCA territory
• competing trials
• prior IV or IA treatment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Interventional mechanical thrombectomy	mechanical thrombectomy	Mechanical thrombectomy with either Penumbra system, TREVO, or Solitaire device for acute stroke symptom onset between 8 - 24 hours

Primary Outcome Measures

Name	Time	Method
Thrombolysis in Cerebral Infarction (TICI) score	6 months

Secondary Outcome Measures

Name	Time	Method
Modified Rankin Scale	6 months
National Institutes of Health Stroke Scale (NIHSS) score	6 months
Montreal Cognitive Assessment (MoCA) tool	6 months

Trial Locations

Locations (1)

Abington Memorial Hospital; 🇺🇸 Abington, Pennsylvania, United States