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

July 31, 2017 updated by: Patricia Bussinger, Abington Memorial Hospital
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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Abington Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • Solitaire
  • Penumbra system
  • TREVO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Thrombolysis in Cerebral Infarction (TICI) score
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
National Institutes of Health Stroke Scale (NIHSS) score
Time Frame: 6 months
6 months
Montreal Cognitive Assessment (MoCA) tool
Time Frame: 6 months
6 months
Modified Rankin Scale
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abington Memorial Hospital

Investigators

  • Principal Investigator: Qaisar Shah, MD, Abington Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Anticipated)

July 1, 2018

Study Completion (Anticipated)

July 1, 2018

Study Registration Dates

First Submitted

July 14, 2015

First Submitted That Met QC Criteria

August 25, 2015

First Posted (Estimate)

August 27, 2015

Study Record Updates

Last Update Posted (Actual)

August 2, 2017

Last Update Submitted That Met QC Criteria

July 31, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G140041

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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