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Trial record 3 of 332 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)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02533778
First Posted: August 27, 2015
Last Update Posted: August 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Patricia Bussinger, Abington Memorial Hospital
  Purpose
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
  • TREVO
  • 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02533778


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

Responsible Party: Patricia Bussinger, MBA CRNP, Abington Memorial Hospital
ClinicalTrials.gov Identifier: NCT02533778     History of Changes
Other Study ID Numbers: G140041
First Submitted: July 14, 2015
First Posted: August 27, 2015
Last Update Posted: August 2, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Stroke
Ischemia
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia