ARISE: After 8 Hours Reperfusion in Ischemic Stroke Embolization

Ischemic Stroke Clinical Trial

— ARISE  

Official title:

ARISE: After 8 Hours Reperfusion in Ischemic Stroke Embolization

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02533778
• Other study ID #: G140041
• Status: Suspended
• Phase: N/A
• First received: July 14, 2015
• Last updated: July 31, 2017
• Start date: July 2015
• Est. completion date: July 1, 2018

Study information

• Verified date: July 2017
• Source: Abington Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 25
• Est. completion date: July 1, 2018
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Device:
• mechanical thrombectomy
Mechanical thrombectomy by either Penumbra system, TREVO, or Solitaire retrieval device

Locations

Country	Name	City	State
United States	Abington Memorial Hospital	Abington	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abington Memorial Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thrombolysis in Cerebral Infarction (TICI) score		6 months
Secondary	National Institutes of Health Stroke Scale (NIHSS) score		6 months
Secondary	Montreal Cognitive Assessment (MoCA) tool		6 months
Secondary	Modified Rankin Scale		6 months