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

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.

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • MUSC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Discharge national institutes of health stroke scale (NIHSS)	a national institutes of health stroke scale (NIHSS) will be obtained at the time of the each patient's discharge or approximately 7 days	approximately 7 days after index stroke

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
90 day modified Rankin Score (mRS)	90 days after procedure each patient's modified Rankin Score will be obtained.	90 days after procedure

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: Stony Brook University; Vanderbilt University; State University of New York - Downstate Medical Center; West Virginia University; Swedish Medical Center
• Investigators: Principal Investigator: Aquilla Turk, DO, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: April 23, 2013
• First Submitted That Met QC Criteria: May 8, 2013
• First Posted (Estimate): May 13, 2013

Study Record Updates

• Last Update Posted (Actual): October 3, 2017
• Last Update Submitted That Met QC Criteria: September 29, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: PRO23524