REal-World Analyses of Stroke - Thrombus Occlusion REtrieval ("RESTORE")

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Acute Ischemic Stroke; Ischemic; Vessel Occlusion
• Intervention / Treatment: Device: MicroVention Mechanical Thrombectomy Devices as first-line treatment

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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Michelle Wetherby; Phone Number: 714.920.3815; Email: michelle.wetherby@microvention.com
• Study Contact Backup: Name: Ophelia Selam, PhD; Phone Number: 503-880-6899; Email: ophelia.selam@microvention.com

Study Locations

• United States
  • California
    • Burbank, California, United States, 91423
      • Recruiting
      • Pacific Neuroscience Institute (Providence)
      • Contact: Michael Okafor
      • Principal Investigator: Sandra Narayanan, MD
    • Carmichael, California, United States, 95608
      • Recruiting
      • Mercy San Juan - Dignity Health Research Institute
      • Principal Investigator: Lucian Maidan, MD
      • Contact: Danielle Hornbuckle
    • Redwood City, California, United States, 94063
      • Recruiting
      • Kaiser Permanente, Northern California
      • Contact: Nancy Mendelssohn
      • Principal Investigator: Robert Darflinger, MD
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
      • Recruiting
      • UCHealth Memorial
      • Contact: Kelsey Hartle
      • Principal Investigator: Ricky Medel, MD
  • Florida
    • Hollywood, Florida, United States, 33021
      • Recruiting
      • Memorial Healthcare System
      • Contact: Pamela Shaw
      • Principal Investigator: Norman Ajiboye, MD
    • Tampa, Florida, United States, 33606
      • Recruiting
      • Tampa General Hospital
      • Principal Investigator: Maxim Mokin, MD
      • Contact: Kilaun Robinson
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Recruiting
      • Augusta University
      • Contact: Patty Ray
      • Principal Investigator: Scott Rahimi, MD
  • Illinois
    • Rockford, Illinois, United States, 61114
      • Recruiting
      • Javon Bea Hospital
      • Contact: Nicole Morud
      • Principal Investigator: Vbhav Bansal, MD
  • Indiana
    • Carmel, Indiana, United States, 46032
      • Recruiting
      • Goodman Campbell Brain and Spine
      • Contact: Emily Vance
      • Principal Investigator: Daniel Sahlein, MD
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Recruiting
      • University of Maryland
      • Contact: Charlesa Plummer
      • Principal Investigator: Timothy Miller, MD
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham and Women's Hospital
      • Contact: Anni Jiaying Schwab Bell
      • Principal Investigator: Mohammad A Aziz-Sultan, MD
    • Springfield, Massachusetts, United States, 01199
      • Recruiting
      • Baystate Medical Center
      • Contact: Andres Santana
      • Principal Investigator: Varun Naragum, MD
  • Michigan
    • Kalamazoo, Michigan, United States, 49048
      • Recruiting
      • Ascension Borgess
      • Contact: Kali Barrow
      • Principal Investigator: Kenneth Kreitel, MD
    • Traverse City, Michigan, United States, 49684
      • Recruiting
      • Munson Medical Center
      • Contact: DeAnn Mosher
      • Principal Investigator: Gary Rajah, MD
    • Wyoming, Michigan, United States, 49519
      • Recruiting
      • University of Michigan Health West
      • Contact: Cindy Karl
      • Principal Investigator: Fazeel Siddiqui, MD
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Recruiting
      • Allina Health (Abbott Northwestern Hospital)
      • Principal Investigator: Josser Delgado, MD
      • Contact: Max Klaiman
  • Missouri
    • Bridgeton, Missouri, United States, 63044
      • Recruiting
      • SSM Health
      • Contact: Makenzie Woodford
      • Principal Investigator: Amer Alshekhlee, MD
    • Columbia, Missouri, United States, 65212
      • Recruiting
      • University of Missouri
      • Contact: Jennifer Randolph
      • Principal Investigator: Farhan Siddiq, MD
    • Saint Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University
      • Contact: Rachel Reed
      • Principal Investigator: Rano Chatterjee, MD
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • Recruiting
      • University of Nebraska Medical Center
      • Contact: Dulce Maroni Veiga
      • Principal Investigator: Daniel Surdell, MD
  • New Jersey
    • Neptune, New Jersey, United States, 07753
      • Recruiting
      • HMH Jersey Shore University Medical Center
      • Contact: Kiro Hannah
      • Principal Investigator: Ghasan Ahmad, MD
  • New York
    • Bronx, New York, United States, 10467
      • Recruiting
      • Montefiore
      • Principal Investigator: Neil Haranhalli, MD
      • Contact: Lavinia Williams
    • Manhasset, New York, United States, 11030
      • Recruiting
      • Northshore University Hospital - Northwell
      • Contact: Patricia Kozikowski
      • Principal Investigator: Henry Woo, MD
    • Stony Brook, New York, United States, 11794
      • Recruiting
      • Stony Brook Medicine
      • Contact: Dawn Madigan
      • Principal Investigator: David Fiorella, MD
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • Recruiting
      • University of Cincinnati
      • Contact: Emily Sayles
      • Principal Investigator: Charles Prestigiacomo, MD
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic
      • Contact: Lauren Todd
      • Principal Investigator: Gabor Toth, MD
    • Toledo, Ohio, United States, 43606
      • Recruiting
      • ProMedica Toledo
      • Contact: Stacy Parlette
      • Principal Investigator: Syed Zaidi, MD
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Recruiting
      • University of Oklahoma Health Science Center
      • Principal Investigator: Hakeem Shakir, MD
      • Contact: Sanaa Hameed
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Recruiting
      • Geisinger
      • Principal Investigator: Clemens Schirmer, MD
      • Contact: Chelsie Derr
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania Health Systems
      • Contact: Yvonne Tsang
      • Principal Investigator: Jan-Karl Burkhardt, MD
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Recruiting
      • Prisma Health Upstate
      • Contact: Sean Mcdermott
      • Principal Investigator: Imran Chaudry, MD
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57104
      • Recruiting
      • Sanford Medical Center
      • Contact: Karla Reilly
      • Principal Investigator: Divyajot Sandhu, MD
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Recruiting
      • Inova
      • Contact: Karlie Smith
      • Principal Investigator: Manuel Fortes, MD
  • Washington
    • Seattle, Washington, United States, 98122
      • Recruiting
      • Swedish Health Services
      • Contact: Janae Rahiman
      • Principal Investigator: Yince Loh, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Cohort I:

Inclusion Criteria:

1. Patient is ≥ 21 and ≤ 85 years of age.
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.

Exclusion Criteria:

1. Inability to obtain written informed consent.
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.

16. 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:

Inclusion Criteria:

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:

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.	Device: MicroVention Mechanical Thrombectomy Devices as first-line treatment; Patient will be treated with mechanical thrombectomy at the direction of the treating physician

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cohort I: Proportion of subjects achieving mTICI ≥ 2b revascularization based on independent core lab assessment	During the procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Mortality at day 90	90 days post-procedure
Proportion of subjects achieving mTICI ≥ 2b revascularization after first line aspiration treatment	During the procedure
Number of passes to achieve mTICI ≥ 2b revascularization with first line aspiration treatment	During the procedure
Proportion of subjects achieving mTICI ≥ 2b revascularization after first aspiration pass	During the procedure
Time from groin puncture to initial contact of clot with aspiration catheter	During the procedure
Time from groin puncture to achieve mTICI ≥ 2b using first line aspiration treatment	During the procedure
Technical success using the MicroVention BOBBY Balloon Guide Catheter based on successful placement at the target location and successful balloon inflation	During the procedure

Collaborators and Investigators

• Sponsor: Microvention-Terumo, Inc.
• Investigators: Principal Investigator: Dheeraj Gandhi, MBBS, MD, University of Maryland, Baltimore; Principal Investigator: Syed Zaidi, MD, ProMedica Toledo

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2020
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: June 24, 2020
• First Submitted That Met QC Criteria: June 26, 2020
• First Posted (Actual): June 30, 2020

Study Record Updates

• Last Update Posted (Estimated): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Mechanical Thrombectomy, Aspiration, SOFIA®, Direct Aspiration, ERIC®
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Ischemia
• Other Study ID Numbers: CL11012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes