ADAPT A Direct Aspiration, First Pass Technique for the Endovascular Treatment of Stroke

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease
Stroke Technique

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.

Study Design

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Study Type :	Observational
Actual Enrollment :	500 participants
Observational Model:	Case-Only
Time Perspective:	Retrospective
Official Title:	ADAPT A Direct Aspiration, First Pass Technique for the Endovascular Treatment of Stroke
Study Start Date :	June 2013
Actual Primary Completion Date :	March 2014
Actual Study Completion Date :	May 2016

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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 :

1. 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.

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Medical University of South Carolina
ClinicalTrials.gov Identifier:	NCT01852227 History of Changes
Other Study ID Numbers:	PRO23524
First Posted:	May 13, 2013
Last Update Posted:	October 3, 2017
Last Verified:	August 2017

Additional relevant MeSH terms:

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases	Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases