Stroke TechniqueNCT01852227
ADAPT A Direct Aspiration, First Pass Technique for the Endovascular Treatment of Stroke
An observational study of Stroke Technique, run by Medical University of South Carolina at 1 site in United States.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke Technique
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- All patients who were treated with direct aspiration as a first pass choice or treated with a stent retriever will be included.
Who cannot join
- Patients not treated with either direct aspiration as a first pass, or stent retriever will not be included.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Stroke Technique
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: approximately 7 days after index stroke
Secondary outcomes (1)
90 day modified Rankin Score (mRS)
90 days after procedure each patient's modified Rankin Score will be obtained.
Measured: 90 days after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2013 (estimated)
- Study startJun 2013
- Primary completionMar 2014
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke TechniqueStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- State University of New York - Downstate Medical Center, Stony Brook University, Swedish Medical Center, Vanderbilt University, West Virginia University
- Responsible party
- Sponsor
- Investigators
- Aquilla Turk, DO, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01852227
- Sponsor's protocol ID
- PRO23524
- Status last verified
- Aug 2017
- First submitted
- 23 Apr 2013
- Last updated
- 3 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ADAPT A Direct Aspiration, First Pass Technique for the Endovascular Treatment of Stroke
- ClinicalTrials.gov ID
- NCT01852227
- Acronym / sponsor ID
- PRO23524
- Conditions
- Stroke Technique
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- State University of New York - Downstate Medical Center, Stony Brook University, Swedish Medical Center, Vanderbilt University, West Virginia University
- Study start
- Jun 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 13 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All patients who were treated with direct aspiration as a first pass choice or treated with a stent retriever will be included.
Key exclusion criteria (1 listed)
- Patients not treated with either direct aspiration as a first pass, or stent retriever will not be included.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
90 day modified Rankin Score (mRS)
Time frame: 90 days after procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aquilla Turk, DO principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke Technique, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discharge national institutes of health stroke scale (NIHSS) (time frame: approximately 7 days after index stroke). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2017.