Clinical trial NCT01852227: ADAPT A Direct Aspiration, First Pass Technique for the Endovascular Treatment of Stroke
Official title: ADAPT A Direct Aspiration, First Pass Technique for the Endovascular Treatment of Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke Technique
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: State University of New York - Downstate Medical Center
name: Stony Brook University
name: Swedish Medical Center
name: Vanderbilt University
name: West Virginia University
First posted: 2013-05-13
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
measure: Discharge national institutes of health stroke scale (NIHSS)
timeFrame: approximately 7 days after index stroke
Secondary outcomes:
measure: 90 day modified Rankin Score (mRS)
timeFrame: 90 days after procedure
Other outcomes:
Locations:
city: Charleston
country: United States
facility: MUSC
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Aquilla Turk, DO
role: PRINCIPAL_INVESTIGATOR
References: