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Trial record 3 of 311 for:    (ARISE)

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

This study has suspended participant recruitment.
(Similar large international competing trial with results of strong positive statistically benefit)
Information provided by (Responsible Party):
Patricia Bussinger, Abington Memorial Hospital Identifier:
First received: July 14, 2015
Last updated: July 31, 2017
Last verified: July 2017
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.

Condition Intervention
Ischemic Stroke Device: mechanical thrombectomy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description:
with control group
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ARISE: After 8 Hours Reperfusion in Ischemic Stroke Embolization

Further study details as provided by Patricia Bussinger, Abington Memorial Hospital:

Primary Outcome Measures:
  • Thrombolysis in Cerebral Infarction (TICI) score [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • National Institutes of Health Stroke Scale (NIHSS) score [ Time Frame: 6 months ]
  • Montreal Cognitive Assessment (MoCA) tool [ Time Frame: 6 months ]
  • Modified Rankin Scale [ Time Frame: 6 months ]

Estimated Enrollment: 25
Study Start Date: July 2015
Estimated Study Completion Date: July 1, 2018
Estimated Primary Completion Date: July 1, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Interventional mechanical thrombectomy
Mechanical thrombectomy with either Penumbra system, TREVO, or Solitaire device for acute stroke symptom onset between 8 - 24 hours
Device: mechanical thrombectomy
Mechanical thrombectomy by either Penumbra system, TREVO, or Solitaire retrieval device
Other Names:
  • Penumbra system
  • Solitaire

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  • 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT02533778

United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Sponsors and Collaborators
Abington Memorial Hospital
Principal Investigator: Qaisar Shah, MD Abington Memorial Hospital
  More Information

Responsible Party: Patricia Bussinger, MBA CRNP, Abington Memorial Hospital Identifier: NCT02533778     History of Changes
Other Study ID Numbers: G140041
Study First Received: July 14, 2015
Last Updated: July 31, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia processed this record on August 18, 2017