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ADAPT A Direct Aspiration, First Pass Technique for the Endovascular Treatment of Stroke
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Purpose
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 |
|---|
| Stroke Technique |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Retrospective |
| Official Title: | ADAPT A Direct Aspiration, First Pass Technique for the Endovascular Treatment of Stroke |
- 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
- 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.
| Estimated Enrollment: | 500 |
| Study Start Date: | June 2013 |
| Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | Child, Adult, Senior |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01852227
| United States, South Carolina | |
| MUSC | |
| Charleston, South Carolina, United States, 29425 | |
| Principal Investigator: | Aquilla Turk, DO | Medical University of South Carolina |
More Information
| Responsible Party: | Medical University of South Carolina |
| ClinicalTrials.gov Identifier: | NCT01852227 History of Changes |
| Other Study ID Numbers: |
PRO23524 |
| Study First Received: | April 23, 2013 |
| Last Updated: | December 14, 2015 |
Additional relevant MeSH terms:
|
Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on June 27, 2017