REal-World Analyses of Stroke - Thrombus Occlusion REtrieval
NCT ID: NCT04451525
Last Updated: 2025-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
710 participants
OBSERVATIONAL
2020-07-15
2025-06-09
Brief Summary
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Detailed Description
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The primary objective of Cohort I of the RESTORE study is to determine the proportion of subjects achieving successful revascularization (mTICI ≥ 2b) with the SOFIA® Flow Plus 6F Aspiration Catheter when used in conjunction with the direct aspiration as first line treatment technique for patients with acute ischemic stroke in the anterior circulation based on collection of real-world evidence data. Secondary objectives include the evaluation of good functional outcome (defined as mRS ≤ 2 at day 90), revascularization time, and procedure related major neurological complications, all based on real-world evidence data collected.
The objective of Cohort II of the study is to evaluate standard outcomes such as successful revascularization (mTICI ≥ 2b), good functional outcome (defined as mRS ≤ 2 at day 90), revascularization time, and procedure related major neurological complications based on real-world evidence data. Additional outcomes may be defined and research questions generated based on review of the collected data.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort I
Cohort I will focus on data collection on the SOFIA® Flow Plus 6F Aspiration Catheter used with the direct aspiration as first line treatment technique with the intent to evaluate per prespecified endpoints.
MicroVention Mechanical Thrombectomy Devices as first-line treatment
Patient will be treated with mechanical thrombectomy at the direction of the treating physician
Cohort II
Cohort II will focus on data collection on MicroVention devices used for acute ischemic stroke treatment with the intent to evaluate standard outcomes while also generating additional research questions for analysis based on data collected.
MicroVention Mechanical Thrombectomy Devices as first-line treatment
Patient will be treated with mechanical thrombectomy at the direction of the treating physician
Interventions
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MicroVention Mechanical Thrombectomy Devices as first-line treatment
Patient will be treated with mechanical thrombectomy at the direction of the treating physician
Eligibility Criteria
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Inclusion Criteria
2. Patient has a pre-morbid mRS ≤ 1.
3. Neuroimaging (CT/CTA and/or MR/MRA collected at no more than 90 minutes prior to groin puncture) demonstrates large vessel proximal occlusion (distal ICA through MCA bifurcation).
4. Patient has an NIHSS score ≥ 5 at time of intervention.
5. Symptom onset is within 8 hours of when groin puncture can be achieved.
6. Patient will undergo treatment via femoral access and the decision to use femoral access has been made by the treating physician outside the context of the RESTORE study and prior to study enrollment.
7. Patient will be treated using the direct aspiration as first line treatment technique and the decision to use this technique and the study device has been made by the treating physician outside the context of the RESTORE study and prior to study enrollment.
8. Patient or patient's legally authorized representative (LAR) has provided written informed consent.
9. Patient is considered by the treating physician to be available for and able to complete all follow-up visits with a trained site investigator.
1. Neuroimaging (CT/CTA and/or MR/MRA) demonstrates intracranial vessel occlusion.
2. Symptom onset is within 24 hours of when arterial access puncture can be achieved.
3. Patient will be treated using an FDA-cleared/approved and market-released MicroVention mechanical thrombectomy device as the initial, primary treatment device and the decision to use this device has been made by the treating physician outside the context of the RESTORE study and prior to study enrollment.
Note: For the purposes of this protocol, ancillary/accessory devices such as balloon guide catheters and other access devices are not considered primary treatment devices. Further, devices used for rescue following attempt of a different primary treatment device are not considered initial primary treatment devices.
4. Patient or patient's legally authorized representative (LAR) has provided written informed consent within 48 hours of procedure.
Exclusion Criteria
2. Patient is \< 21 or \> 85 years of age.
3. Patient has a pre-morbid mRS ≥ 2.
4. More than 8 hours have passed since symptom onset.
5. Severe unilateral or bilateral carotid artery stenosis or dissection requiring stent treatment.
6. Presence of a pre-existing large territory infarction.
7. Absent femoral pulses or other condition preventing femoral access.
8. Patient has vascular anatomy/tortuosity or other vascular disease preventing access to the target occlusion or that will likely result in unstable access.
9. Patient is pregnant.
10. Known or suspected pre-existing/chronic large vessel occlusion in the symptomatic territory.
11. Patient has known, untreatable hypersensitivity to contrast dye, iodine or any component of the treatment device that cannot be medically controlled.
12. The intracranial occlusion is suspected to be chronic based on past imaging, clinical history, or clinical judgment.
13. Patient has a severe or life-threatening comorbidity that could confound study results, or that will render the procedure unlikely to benefit the patient.
14. Patient is unable to complete scheduled follow-up assessments due to comorbidities, geographical limitations, or a life expectancy of less than 3 months.
15. Patient is enrolled in another device or drug study in which participation could confound study results.
* Presence of intracerebral hemorrhage as evidenced on initial imaging
* Ischemic changes in the posterior circulation territories (including the vertebra-basilar and posterior cerebral arteries)
* Significant mass effect with midline shift
* Evidence of intracranial tumor
* Baseline ischemic core lesion \>50 cc
* Involvement of \> 1/3 of the middle cerebral artery territory
* ASPECTS \<6 (hemispheric sulcal effacement and/or loss of grey-white differentiation alone are not contraindications for treatment)
Cohort II:
1. Inability to obtain written informed consent within 48 hours of procedure.
2. Patient is enrolled in another device or drug study in which participation could confound study results.
ALL
No
Sponsors
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Microvention-Terumo, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Dheeraj Gandhi, MBBS, MD
Role: PRINCIPAL_INVESTIGATOR
University of Maryland, Baltimore
Syed Zaidi, MD
Role: PRINCIPAL_INVESTIGATOR
ProMedica Toledo
Locations
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Pacific Neuroscience Institute (Providence)
Burbank, California, United States
Mercy San Juan - Dignity Health Research Institute
Carmichael, California, United States
Kaiser Permanente, Northern California
Redwood City, California, United States
UCHealth Memorial
Colorado Springs, Colorado, United States
Memorial Healthcare System
Hollywood, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Augusta University
Augusta, Georgia, United States
The Queen's Medical Center
Honolulu, Hawaii, United States
Javon Bea Hospital
Rockford, Illinois, United States
Goodman Campbell Brain and Spine
Carmel, Indiana, United States
University of Maryland
Baltimore, Maryland, United States
Brigham and Women's hospital
Boston, Massachusetts, United States
Baystate Medical Center
Springfield, Massachusetts, United States
Ascension Borgess
Kalamazoo, Michigan, United States
Munson Medical Center
Traverse City, Michigan, United States
University of Michigan Health West
Wyoming, Michigan, United States
Allina Health (Abbott Northwestern Hospital)
Minneapolis, Minnesota, United States
SSM Health
Bridgeton, Missouri, United States
University of Missouri
Columbia, Missouri, United States
Washington University
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
HMH Jersey Shore University Medical Center
Neptune City, New Jersey, United States
Northshore University Hospital - Northwell
Manhasset, New York, United States
Mt. Sinai Health System
New York, New York, United States
Stony Brook Medicine
Stony Brook, New York, United States
Montefiore
The Bronx, New York, United States
University of Cincinnati
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
ProMedica Toledo
Toledo, Ohio, United States
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, United States
Geisinger
Danville, Pennsylvania, United States
University of Pennsylvania Health Systems
Philadelphia, Pennsylvania, United States
Prisma Health Upstate
Greenville, South Carolina, United States
Sanford Medical Center
Sioux Falls, South Dakota, United States
Semmes Murphy Clinic
Memphis, Tennessee, United States
INOVA
Falls Church, Virginia, United States
Swedish Health Services
Seattle, Washington, United States
Countries
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Other Identifiers
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CL11012
Identifier Type: -
Identifier Source: org_study_id
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