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

Completed

• Conditions: Stroke Technique

• Registration Number: NCT01852227
• Lead Sponsor: Medical University of South Carolina

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.

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 Timeline

• Study First Submitted: 2013-04-23
• Study First Submitted QC: 2013-05-08
• Study First Posted: 2013-05-13
• Study Start: 2013-06
• Primary Completion: 2014-03
• Study Completion: 2016-05
• Status Verified: 2017-08
• Last Update Submitted: 2017-09-29
• Last Update Posted: 2017-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Discharge national institutes of health stroke scale (NIHSS)	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

Name	Time	Method
90 day modified Rankin Score (mRS)	90 days after procedure	90 days after procedure each patient's modified Rankin Score will be obtained.

Trial Locations

Locations (1)

MUSC; 🇺🇸 Charleston, South Carolina, United States