ARISE: After 8 Hours Reperfusion in Ischemic Stroke Embolization

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2018-07-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Ischemic Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

with control group

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Interventional mechanical thrombectomy

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

Group Type EXPERIMENTAL

mechanical thrombectomy

Intervention Type DEVICE

Mechanical thrombectomy by either Penumbra system, TREVO, or Solitaire retrieval device

Interventions

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mechanical thrombectomy

Mechanical thrombectomy by either Penumbra system, TREVO, or Solitaire retrieval device

Intervention Type DEVICE

Other Intervention Names

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Penumbra system TREVO Solitaire

Eligibility Criteria

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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