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Trial record 1 of 1 for:    NCT01852227
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ADAPT A Direct Aspiration, First Pass Technique for the Endovascular Treatment of Stroke

This study has been completed.
Sponsor:
Collaborators:
State University of New York - Downstate Medical Center
Stony Brook University
Swedish Medical Center
Vanderbilt University
West Virginia University
Information provided by (Responsible Party):
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01852227
First received: April 23, 2013
Last updated: December 14, 2015
Last verified: April 2013
  Purpose

In collaboration with the Neurointerventional programs at state university of new york Buffalo, state university of new york Stonybrook, Swedish Medical Center, Erlanger Health System, Vanderbilt University, and West Virginia University School of Medicine, the investigators aim to prospectively collect experiences where direct aspiration as a first pass technique is used for thrombectomy procedures.

The investigators also want to compare specific characteristics from these cases to other stroke cases where traditional thrombectomy devices were used.


Condition
Stroke Technique

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: ADAPT A Direct Aspiration, First Pass Technique for the Endovascular Treatment of Stroke

Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • Discharge national institutes of health stroke scale (NIHSS) [ Time Frame: approximately 7 days after index stroke ]
    a national institutes of health stroke scale (NIHSS) will be obtained at the time of the each patient's discharge or approximately 7 days


Secondary Outcome Measures:
  • 90 day modified Rankin Score (mRS) [ Time Frame: 90 days after procedure ]
    90 days after procedure each patient's modified Rankin Score will be obtained.


Estimated Enrollment: 500
Study Start Date: June 2013
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Detailed Description:

Traditionally, at a physician's discretion, first pass attempts at thrombectomy procedures are performed with any number of FDA cleared catheters, guide wires, and devices designed for efficient removal of clot within an intracranial vessel. Among institutions involved in this case study, the latest devices are readily available and fully support standard treatment paradigms.

However, several cases, recently completed, using only large bore catheter and aspiration have anecdotally demonstrated a superior ability to remove clot from vessels, restoring blood flow to the affected vessel and brain tissue. In these limited number of cases, full restoration of blood flow has been achieved. While this combination of approved devices is minimalistic, the efficiency of the procedure, rapid technical success, and relative simplicity of the approach is unique and should be thoroughly reviewed and possibly prepared for publication.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This is a chart review of clinical data for patients who have been treated for stroke with either direct aspiration or stent retrievers. This review will be conducted at MUSC and SUNY Buffalo, SUNY Stonybrook, Swedish Medical Center, Vanderbilt University, Erlanger Health System, and West Virginia University School of Medicine. Each participating group will submit for approval at their individual institution.
Criteria

Inclusion Criteria:

  • All patients who were treated with direct aspiration as a first pass choice or treated with a stent retriever will be included.

Exclusion Criteria:

  • Patients not treated with either direct aspiration as a first pass, or stent retriever will not be included.
  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: NCT01852227

Locations
United States, South Carolina
MUSC
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
State University of New York - Downstate Medical Center
Stony Brook University
Swedish Medical Center
Vanderbilt University
West Virginia University
Investigators
Principal Investigator: Aquilla Turk, DO Medical University of South Carolina
  More Information

Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01852227     History of Changes
Other Study ID Numbers: PRO23524
Study First Received: April 23, 2013
Last Updated: December 14, 2015

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on March 24, 2017