REal-World Analyses of Stroke - Thrombus Occlusion REtrieval

NCT04451525 | Completed FDA Device

• 1 other identifier: CL11012
• Study Type: observational
• Target: 710
• Locations: 1 country
• Sites: 37

Brief 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.

Conditions

Acute Ischemic Stroke; Vessel Occlusion; Stroke; Ischemic

Keywords

Mechanical Thrombectomy, Aspiration, SOFIA®, Direct Aspiration, ERIC®

Outcome Measures

Primary Outcomes (1)

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

  During the procedure

Secondary Outcomes (12)

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

  90 days

• Occurrence of procedure related serious adverse events

  During the procedure through study completion at 90 days

• Occurrence of sICH within 24 hours

  24 hours post-operative

• Occurrence of embolization to new territories (ENT)

  During the procedure

• Presence of vasospasm involving the accessed vascular tree

  During the procedure through 24 hours post-operative

Study Arms (2)

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.

Device: MicroVention Mechanical Thrombectomy Devices as first-line treatment

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.

Device: MicroVention Mechanical Thrombectomy Devices as first-line treatment

Interventions

MicroVention Mechanical Thrombectomy Devices as first-line treatment DEVICE

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

Cohort I; Cohort II

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Microvention-Terumo, Inc.: lead

Study Sites (37)

Pacific Neuroscience Institute (Providence)

Burbank, California, 91423, United States

Location

Mercy San Juan - Dignity Health Research Institute

Carmichael, California, 95608, United States

Location

Kaiser Permanente, Northern California

Redwood City, California, 94063, United States

Location

UCHealth Memorial

Colorado Springs, Colorado, 80909, United States

Location

Memorial Healthcare System

Hollywood, Florida, 33021, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Augusta University

Augusta, Georgia, 30912, United States

Location

The Queen's Medical Center

Honolulu, Hawaii, 96813, United States

Location

Javon Bea Hospital

Rockford, Illinois, 61114, United States

Location

Goodman Campbell Brain and Spine

Carmel, Indiana, 46032, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Brigham and Women's hospital

Boston, Massachusetts, 02115, United States

Location

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

Ascension Borgess

Kalamazoo, Michigan, 49048, United States

Location

Munson Medical Center

Traverse City, Michigan, 49684, United States

Location

University of Michigan Health West

Wyoming, Michigan, 49519, United States

Location

Allina Health (Abbott Northwestern Hospital)

Minneapolis, Minnesota, 55407, United States

Location

SSM Health

Bridgeton, Missouri, 63044, United States

Location

University of Missouri

Columbia, Missouri, 65212, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

HMH Jersey Shore University Medical Center

Neptune City, New Jersey, 07753, United States

Location

Northshore University Hospital - Northwell

Manhasset, New York, 11030, United States

Location

Mt. Sinai Health System

New York, New York, 10029, United States

Location

Stony Brook Medicine

Stony Brook, New York, 11794, United States

Location

Montefiore

The Bronx, New York, 10467, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

ProMedica Toledo

Toledo, Ohio, 43606, United States

Location

University of Oklahoma Health Science Center

Oklahoma City, Oklahoma, 73104, United States

Location

Geisinger

Danville, Pennsylvania, 17822, United States

Location

University of Pennsylvania Health Systems

Philadelphia, Pennsylvania, 19104, United States

Location

Prisma Health Upstate

Greenville, South Carolina, 29605, United States

Location

Sanford Medical Center

Sioux Falls, South Dakota, 57104, United States

Location

Semmes Murphy Clinic

Memphis, Tennessee, 38120, United States

Location

INOVA

Falls Church, Virginia, 22042, United States

Location

Swedish Health Services

Seattle, Washington, 98122, United States

Location

MeSH Terms

Conditions

Ischemic Stroke; Stroke; Ischemia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dheeraj Gandhi, MBBS, MD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

• Syed Zaidi, MD

  ProMedica Toledo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2020
• First Posted: June 30, 2020
• Study Start: July 15, 2020
• Primary Completion: May 29, 2025
• Study Completion: June 9, 2025
• Last Updated: June 18, 2025

Record last verified: 2025-06

Locations

US (37)