ARISE: After 8 Hours Reperfusion in Ischemic Stroke Embolization

Abington Memorial Hospital

Status: Suspended

Conditions: Ischemic Stroke

Treatments: Device: mechanical thrombectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02533778

G140041

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Interventional mechanical thrombectomy

Experimental group

Description:

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

Treatment:

Device: mechanical thrombectomy