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Acute Ischemic Stroke"RESTORE"NCT04451525

REal-World Analyses of Stroke - Thrombus Occlusion REtrieval

An observational study of Acute Ischemic Stroke and Vessel Occlusion, run by Microvention-Terumo, Inc. at 37 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To collect real-world evidence allowing assessment of functional, imaging, and safety outcomes of MicroVention market-released acute ischemic stroke devices when used at the direction of the treating physician. Read more about this study

Who is it for?
Any age
Conditions the study is for
Acute Ischemic Stroke, Vessel Occlusion, Stroke
What is being tested?
MicroVention Mechanical Thrombectomy Devices as first-line treatment
Type of treatment
Medical device
How many people
710 participants
Where
37 sitesUnited States
Study dates
15 Jul 2020to 9 Jun 2025
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: Adults with acute ischemic stroke in the cerebral circulation who will be treated with mechanical thrombectomy at the direction of the treating physician.

Who may be able to join

  • Patient is ≥ 21 and ≤ 85 years of age.
  • Patient has a pre-morbid mRS ≤ 1.
  • 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).
  • Patient has an NIHSS score ≥ 5 at time of intervention.
  • Symptom onset is within 8 hours of when groin puncture can be achieved.
  • 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.
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  • 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.
  • Patient or patient's legally authorized representative (LAR) has provided written informed consent.
  • Patient is considered by the treating physician to be available for and able to complete all follow-up visits with a trained site investigator.
  • Neuroimaging (CT/CTA and/or MR/MRA) demonstrates intracranial vessel occlusion.
  • Symptom onset is within 24 hours of when arterial access puncture can be achieved.
  • 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.
  • Patient or patient's legally authorized representative (LAR) has provided written informed consent within 48 hours of procedure.

Who cannot join

  • Inability to obtain written informed consent.
  • Patient is < 21 or > 85 years of age.
  • Patient has a pre-morbid mRS ≥ 2.
  • More than 8 hours have passed since symptom onset.
  • Severe unilateral or bilateral carotid artery stenosis or dissection requiring stent treatment.
  • Presence of a pre-existing large territory infarction.
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  • Absent femoral pulses or other condition preventing femoral access.
  • Patient has vascular anatomy/tortuosity or other vascular disease preventing access to the target occlusion or that will likely result in unstable access.
  • Patient is pregnant.
  • Known or suspected pre-existing/chronic large vessel occlusion in the symptomatic territory.
  • Patient has known, untreatable hypersensitivity to contrast dye, iodine or any component of the treatment device that cannot be medically controlled.
  • The intracranial occlusion is suspected to be chronic based on past imaging, clinical history, or clinical judgment.
  • Patient has a severe or life-threatening comorbidity that could confound study results, or that will render the procedure unlikely to benefit the patient.
  • Patient is unable to complete scheduled follow-up assessments due to comorbidities, geographical limitations, or a life expectancy of less than 3 months.
  • Patient is enrolled in another device or drug study in which participation could confound study results.
  • Imaging (CT or MR) exclusion criteria:
  • 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:
  • Inability to obtain written informed consent within 48 hours of procedure.
  • Patient is enrolled in another device or drug study in which participation could confound study results.

Trial locations and contacts

37 sites in 1 country.

37 sites in 1 country

United States37 sites

  • Augusta University

    Augusta, Georgia, 30912

  • University of Maryland

    Baltimore, Maryland, 21201

  • Brigham and Women's hospital

    Boston, Massachusetts, 02115

  • SSM Health

    Bridgeton, Missouri, 63044

  • Pacific Neuroscience Institute (Providence)

    Burbank, California, 91423

  • Goodman Campbell Brain and Spine

    Carmel, Indiana, 46032

  • Mercy San Juan - Dignity Health Research Institute

    Carmichael, California, 95608

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • UCHealth Memorial

    Colorado Springs, Colorado, 80909

  • University of Missouri

    Columbia, Missouri, 65212

  • Geisinger

    Danville, Pennsylvania, 17822

  • INOVA

    Falls Church, Virginia, 22042

  • Prisma Health Upstate

    Greenville, South Carolina, 29605

  • Memorial Healthcare System

    Hollywood, Florida, 33021

  • The Queen's Medical Center

    Honolulu, Hawaii, 96813

  • Ascension Borgess

    Kalamazoo, Michigan, 49048

  • Northshore University Hospital - Northwell

    Manhasset, New York, 11030

  • Semmes Murphy Clinic

    Memphis, Tennessee, 38120

  • Allina Health (Abbott Northwestern Hospital)

    Minneapolis, Minnesota, 55407

  • HMH Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753

  • Mt. Sinai Health System

    New York, New York, 10029

  • University of Oklahoma Health Science Center

    Oklahoma City, Oklahoma, 73104

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • University of Pennsylvania Health Systems

    Philadelphia, Pennsylvania, 19104

  • Kaiser Permanente, Northern California

    Redwood City, California, 94063

  • Javon Bea Hospital

    Rockford, Illinois, 61114

  • Swedish Health Services

    Seattle, Washington, 98122

  • Sanford Medical Center

    Sioux Falls, South Dakota, 57104

  • Baystate Medical Center

    Springfield, Massachusetts, 01199

  • Washington University

    St Louis, Missouri, 63110

  • Stony Brook Medicine

    Stony Brook, New York, 11794

  • Tampa General Hospital

    Tampa, Florida, 33606

  • Montefiore

    The Bronx, New York, 10467

  • ProMedica Toledo

    Toledo, Ohio, 43606

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • University of Michigan Health West

    Wyoming, Michigan, 49519

Other trials in United States

About this study

To collect real-world evidence allowing assessment of functional, imaging, and safety outcomes of MicroVention market-released acute ischemic stroke devices when used at the direction of the treating physician.

Read the detailed description

This is a prospective, multi-center, single arm, observational, Real World Evidence (RWE) post-market study with two cohorts.

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.

Being tested
MicroVention Mechanical Thrombectomy Devices as first-line treatment
Keywords
Mechanical Thrombectomy, Aspiration, SOFIA®, Direct Aspiration, ERIC®
Medical subject headings
Ischemic Stroke, Stroke, Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MicroVention Mechanical Thrombectomy Devices as first-line treatmentDevice

    Patient will be treated with mechanical thrombectomy at the direction of the treating physician

Study groups in NCT04451525
Study groupRoleWhat they receive
Cohort ICohort 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.
Receives: Device: MicroVention Mechanical Thrombectomy Devices as first-line treatment
Cohort IICohort 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.
Receives: Device: MicroVention Mechanical Thrombectomy Devices as first-line treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cohort I: Proportion of subjects achieving mTICI ≥ 2b revascularization based on independent core lab assessment

    Measured: During the procedure

Secondary outcomes (12)

  1. Proportion of subjects with good functional outcome defined as mRS ≤ 2

    Measured: 90 days

  2. Occurrence of procedure related serious adverse events

    Measured: During the procedure through study completion at 90 days

  3. Occurrence of sICH within 24 hours

    Measured: 24 hours post-operative

  4. Occurrence of embolization to new territories (ENT)

    Measured: During the procedure

  5. Presence of vasospasm involving the accessed vascular tree

    Measured: During the procedure through 24 hours post-operative

  6. Mortality at day 90

    Measured: 90 days post-procedure

  7. Proportion of subjects achieving mTICI ≥ 2b revascularization after first line aspiration treatment

    Measured: During the procedure

  8. Number of passes to achieve mTICI ≥ 2b revascularization with first line aspiration treatment

    Measured: During the procedure

  9. Proportion of subjects achieving mTICI ≥ 2b revascularization after first aspiration pass

    Measured: During the procedure

  10. Time from groin puncture to initial contact of clot with aspiration catheter

    Measured: During the procedure

  11. Time from groin puncture to achieve mTICI ≥ 2b using first line aspiration treatment

    Measured: During the procedure

  12. Technical success using the MicroVention BOBBY Balloon Guide Catheter based on successful placement at the target location and successful balloon inflation

    Measured: During the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2020
  2. Study start15 Jul 2020
  3. Primary completion29 May 2025
  4. Study completion9 Jun 2025

Resources

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
Cohort
Time perspective
Prospective
Enrolment
710 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04451525
Sponsor's protocol ID
CL11012
Acronym
"RESTORE"
Status last verified
Jun 2025
First submitted
24 Jun 2020
Last updated
18 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Ischemic Stroke and Vessel Occlusion, run by Microvention-Terumo, Inc. at 37 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 14 inclusion and 26 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 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 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?

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?

Cohort I: Proportion of subjects achieving mTICI ≥ 2b revascularization based on independent core lab assessment (time frame: During the procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04451525.

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 18 Jun 2025.

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