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Trial record 3 of 283 for:    (ARISE)

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Abington Memorial Hospital
Sponsor:
Information provided by (Responsible Party):
Patricia Bussinger, Abington Memorial Hospital
ClinicalTrials.gov Identifier:
NCT02533778
First received: July 14, 2015
Last updated: July 14, 2016
Last verified: July 2016
  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 Phase
Ischemic Stroke
Device: mechanical thrombectomy
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: ARISE: After 8 Hours Reperfusion in Ischemic Stroke Embolization

Further study details as provided by Abington Memorial Hospital:

Primary Outcome Measures:
  • Thrombolysis in Cerebral Infarction (TICI) score [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

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

Estimated Enrollment: 25
Study Start Date: July 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02533778

Contacts
Contact: Patricia Bussinger, MBA CRNP 215-481-3145 pbussinger@amh.org

Locations
United States, Pennsylvania
Abington Memorial Hospital Recruiting
Abington, Pennsylvania, United States, 19001
Contact: Patricia Bussinger, MBA CRNP    215-481-3145    Patricia.Bussinger@Jefferson.edu   
Principal Investigator: Qaisar Shah, MD         
Principal Investigator: Patricia Bussinger, MBA CRNP         
Sub-Investigator: Larami MacKenzie, MD         
Sub-Investigator: Hana Choe, MD         
Sub-Investigator: Kozak Osman, MD         
Sub-Investigator: Karin Jonczak, CRNP         
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 
Study First Received: July 14, 2015
Last Updated: July 14, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
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

ClinicalTrials.gov processed this record on September 27, 2016