Acute Ischemic StrokeNCT05518240
Comparison of Solitaire to Embotrap to Treat Large Vessel Occlusion in Acute Ischemic Stroke (SOLTRAP Study)
An observational study of Acute Ischemic Stroke, run by WellStar Health System at 2 sites in United States.
Trial summary
The primary aim of this study is to assess if there is a difference in first pass reperfusion between the two devices. This is a randomized prospective study to assess if there is a difference in first pass reperfusion at two centers with large mechanical thrombectomy volumes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Stent Retrievers and Stent Retriever
- Type of treatment
- Medical device
- How many people
- 418 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Aug 2022to 1 Jan 2025
- How long will I take part?
- 90 Days
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Subjects who experienced acute ischemic stroke (AIS), eligible for restoration of blood flow using a Solitaire or Embotrap device to remove thrombus from the neurovasculature
Who may be able to join
- Subjects who experienced acute ischemic stroke (AIS), eligible for restoration of blood flow using a Solitaire or Embotrap device to remove thrombus from the neurovasculature
- Occlusion of intracranial cerebral circulation vessel involving the M1, M2 MCA or ICA-T (Tandem occlusions will be enrolled)
- Subject or subject's legally authorized representative (LAR) has signed the informed consent form prior to or within 72 hours post-procedure
- Subject is willing to comply with the protocol follow-up requirements
- The intended technique and treated technique must be one of the following techniques for the first thrombectomy pass in the neurovasculature per Instructions for Use (IFU).
Who cannot join
- 1.The subject can participate in another clinical trial if the study does not impact the endpoints defined in this protocol given this is a data collection trial. Patients who are unable to comply wit the 90 day follow up in person or via telephone will be excluded from the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Wellstar Kennestone Hospital
Marietta, Georgia, 30060
Erica Ononiwu, 470-793-4554, Erica.ononiwu@wellstar.org
Wellstar Research Institute, research@wellstar.org
- Recruiting
Wellstar North Fulton Hospital
Roswell, Georgia, 30076
Erica Ononiwe, 470-793-7554, Erica.ononiwu@wellstar.org
Benjamin Zussman, MD
About this study
The primary aim of this study is to assess if there is a difference in first pass reperfusion between the two devices. This is a randomized prospective study to assess if there is a difference in first pass reperfusion at two centers with large mechanical thrombectomy volumes. Data will also be collected on time-to treatment, outcomes and hemorrhagic complications.
Read the detailed description
The SOLTRAP Study is an investigator initiated two hospital study designed to assess the procedural success and clinical outcomes associated with mechanical thrombectomy using the Medtronic Solitaire Device and the Cerenovous Embotrap device. Both devices are FDA approved for this indication of removal of a thrombus for patients suffering from stroke secondary to a large vessel occlusion.
Data collected will include device used during the procedure, mechanical thrombectomy techniques, time from onset to imaging, imaging to puncture, and overall time from onset to reperfusion as well as quality of life at 90 days post stroke.
The study will enroll up to 418 subjects and will be conducted at Wellstar North Fulton Hospital and Wellstar Kennestone Hospital. The devices will have regulatory authorization to be on the market in the geographic location of both sites.
The duration of the Registry protocol is approximately 24 months
- Conditions
- Acute Ischemic Stroke
- Being tested
- Stent Retrievers, Stent Retriever
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stent RetrieversDevice
Procedure: Embotrap device
Stent RetrieverDevice
Procedure: Solitaire device
| Study group | Role | What they receive |
|---|---|---|
| Acute ischemic stroke (AIS) | Patients who experienced acute ischemic stroke (AIS), eligible for restoration of blood flow using a Solitaire or Embotrap device to remove thrombus from the neurovasculature Receives: Device: Stent Retrievers; Device: Stent Retriever |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of Disability
assessed by mRS with a good functional outcome defined as mRS of 0-2 for each technique
Measured: Day 90 (+14)
Secondary outcomes (1)
Excellent functional outcome
defined as mRS 0-1 at Day 90
Measured: Day 90 (+14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start24 Aug 2022 (estimated)
- Primary completion7 Aug 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 418 participants (estimated)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- WellStar Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Zussman, MD, WellStar Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05518240
- Sponsor's protocol ID
- Sol9058
- Status last verified
- Aug 2022
- First submitted
- 24 Aug 2022
- Last updated
- 26 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Solitaire to Embotrap to Treat Large Vessel Occlusion in Acute Ischemic Stroke (SOLTRAP Study)
- ClinicalTrials.gov ID
- NCT05518240
- Acronym / sponsor ID
- Sol9058
- Conditions
- Acute Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 418 participants (estimated)
- Lead sponsor
- WellStar Health SystemUniversity, hospital or other
- Study start
- 24 Aug 2022 (estimated)
- Primary completion
- 7 Aug 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 26 Aug 2022 (actual)
- 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.
The primary aim of this study is to assess if there is a difference in first pass reperfusion between the two devices. This is a randomized prospective study to assess if there is a difference in first pass reperfusion at two centers with large mechanical thrombectomy volumes. Data will also be collected on time-to treatment, outcomes and hemorrhagic complications.
Detailed description
The SOLTRAP Study is an investigator initiated two hospital study designed to assess the procedural success and clinical outcomes associated with mechanical thrombectomy using the Medtronic Solitaire Device and the Cerenovous Embotrap device. Both devices are FDA approved for this indication of removal of a thrombus for patients suffering from stroke secondary to a large vessel occlusion.
Data collected will include device used during the procedure, mechanical thrombectomy techniques, time from onset to imaging, imaging to puncture, and overall time from onset to reperfusion as well as quality of life at 90 days post stroke.
The study will enroll up to 418 subjects and will be conducted at Wellstar North Fulton Hospital and Wellstar Kennestone Hospital. The devices will have regulatory authorization to be on the market in the geographic location of both sites.
The duration of the Registry protocol is approximately 24 months
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute ischemic stroke (AIS) | – | Device: Stent Retrievers, Device: Stent RetrieverPatients who experienced acute ischemic stroke (AIS), eligible for restoration of blood flow using a Solitaire or Embotrap device to remove thrombus from the neurovasculature |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects who experienced acute ischemic stroke (AIS), eligible for restoration of blood flow using a Solitaire or Embotrap device to remove thrombus from the neurovasculature
Key inclusion criteria (5 listed)
- Subjects who experienced acute ischemic stroke (AIS), eligible for restoration of blood flow using a Solitaire or Embotrap device to remove thrombus from the neurovasculature
- Occlusion of intracranial cerebral circulation vessel involving the M1, M2 MCA or ICA-T (Tandem occlusions will be enrolled)
- Subject or subject's legally authorized representative (LAR) has signed the informed consent form prior to or within 72 hours post-procedure
- Subject is willing to comply with the protocol follow-up requirements
- The intended technique and treated technique must be one of the following techniques for the first thrombectomy pass in the neurovasculature per Instructions for Use (IFU).
Key exclusion criteria (1 listed)
- 1.The subject can participate in another clinical trial if the study does not impact the endpoints defined in this protocol given this is a data collection trial. Patients who are unable to comply wit the 90 day follow up in person or via telephone will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stent RetrieversProcedure: Embotrap device | Device | Acute ischemic stroke (AIS) |
| Stent RetrieverProcedure: Solitaire device | Device | Acute ischemic stroke (AIS) |
Primary outcome
Severity of Disability
Time frame: Day 90 (+14)
assessed by mRS with a good functional outcome defined as mRS of 0-2 for each technique
1 secondary outcome
Excellent functional outcome
Time frame: Day 90 (+14)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke, run by WellStar Health System at 2 sites 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 5 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: status not confirmed, as of the sponsor's last update on 26 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of Disability (time frame: Day 90 (+14)). 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 26 Aug 2022.