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ARISE: After 8 Hours Reperfusion in Ischemic Stroke Embolization (ARISE)

Primary Purpose

Ischemic Stroke

Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
mechanical thrombectomy
Sponsored by
Abington Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Abington Memorial Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Interventional mechanical thrombectomy

Arm Description

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

Outcomes

Primary Outcome Measures

Thrombolysis in Cerebral Infarction (TICI) score

Secondary Outcome Measures

National Institutes of Health Stroke Scale (NIHSS) score
Montreal Cognitive Assessment (MoCA) tool
Modified Rankin Scale

Full Information

First Posted
July 14, 2015
Last Updated
July 31, 2017
Sponsor
Abington Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02533778
Brief Title
ARISE: After 8 Hours Reperfusion in Ischemic Stroke Embolization
Acronym
ARISE
Official Title
ARISE: After 8 Hours Reperfusion in Ischemic Stroke Embolization
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Suspended
Why Stopped
Similar large international competing trial with results of strong positive statistically benefit
Study Start Date
July 2015 (undefined)
Primary Completion Date
July 1, 2018 (Anticipated)
Study Completion Date
July 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Abington Memorial Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
with control group
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interventional mechanical thrombectomy
Arm Type
Experimental
Arm Description
Mechanical thrombectomy with either Penumbra system, TREVO, or Solitaire device for acute stroke symptom onset between 8 - 24 hours
Intervention Type
Device
Intervention Name(s)
mechanical thrombectomy
Other Intervention Name(s)
Penumbra system, TREVO, Solitaire
Intervention Description
Mechanical thrombectomy by either Penumbra system, TREVO, or Solitaire retrieval device
Primary Outcome Measure Information:
Title
Thrombolysis in Cerebral Infarction (TICI) score
Time Frame
6 months
Secondary Outcome Measure Information:
Title
National Institutes of Health Stroke Scale (NIHSS) score
Time Frame
6 months
Title
Montreal Cognitive Assessment (MoCA) tool
Time Frame
6 months
Title
Modified Rankin Scale
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qaisar Shah, MD
Organizational Affiliation
Abington Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abington Memorial Hospital
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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ARISE: After 8 Hours Reperfusion in Ischemic Stroke Embolization

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