Comparison of Solitaire to Embotrap to Treat Large Vessel Occlusion in Acute Ischemic Stroke (SOLTRAP Study)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Georgia
-
Marietta, Georgia, United States, 30060
- Recruiting
- Wellstar Kennestone Hospital
-
Contact:
- Erica Ononiwu
- Phone Number: 470-793-4554
- Email: Erica.ononiwu@wellstar.org
-
Contact:
- Wellstar Research Institute
- Email: research@wellstar.org
-
Principal Investigator:
- Benjamin Zussman, MD
-
Roswell, Georgia, United States, 30076
- Recruiting
- Wellstar North Fulton Hospital
-
Principal Investigator:
- Benjamin Zussman, MD
-
Contact:
- Erica Ononiwe
- Phone Number: 470-793-7554
- Email: Erica.ononiwu@wellstar.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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
|
Procedure: Embotrap device
Procedure: Solitaire device
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Day 90 (+14)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Excellent functional outcome
Time Frame: Day 90 (+14)
|
defined as mRS 0-1 at Day 90
|
Day 90 (+14)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Sol9058
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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