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

Stroke Technique Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01852227
• Other study ID #: PRO23524
• Status: Completed
• Phase: N/A
• First received: April 23, 2013
• Last updated: September 29, 2017
• Start date: June 2013
• Est. completion date: May 2016

Study information

• Verified date: August 2017
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: May 2016
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke
• Stroke Technique

Locations

Country	Name	City	State
United States	MUSC	Charleston	South Carolina

Sponsors (6)

Lead Sponsor	Collaborator
Medical University of South Carolina	State University of New York - Downstate Medical Center, Stony Brook University, Swedish Medical Center, Vanderbilt University, West Virginia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	90 day modified Rankin Score (mRS)	90 days after procedure each patient's modified Rankin Score will be obtained.	90 days after procedure