Clinical trial NCT04451525: REal-World Analyses of Stroke - Thrombus Occlusion REtrieval
Official title: REal-World Analyses of Stroke - Thrombus Occlusion REtrieval
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Ischemic Stroke
Vessel Occlusion
Stroke
Ischemic
Keywords: Mechanical Thrombectomy, Aspiration, SOFIA®, Direct Aspiration, ERIC®
Lead sponsor: Microvention-Terumo, Inc.
Sponsor class: INDUSTRY
First posted: 2020-06-30
Enrollment: 710
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cohort I: Proportion of subjects achieving mTICI ≥ 2b revascularization based on independent core lab assessment
timeFrame: During the procedure
Secondary outcomes:
measure: Proportion of subjects with good functional outcome defined as mRS ≤ 2
timeFrame: 90 days
measure: Occurrence of procedure related serious adverse events
timeFrame: During the procedure through study completion at 90 days
measure: Occurrence of sICH within 24 hours
timeFrame: 24 hours post-operative
measure: Occurrence of embolization to new territories (ENT)
timeFrame: During the procedure
measure: Presence of vasospasm involving the accessed vascular tree
timeFrame: During the procedure through 24 hours post-operative
measure: Mortality at day 90
timeFrame: 90 days post-procedure
measure: Proportion of subjects achieving mTICI ≥ 2b revascularization after first line aspiration treatment
timeFrame: During the procedure
measure: Number of passes to achieve mTICI ≥ 2b revascularization with first line aspiration treatment
timeFrame: During the procedure
measure: Proportion of subjects achieving mTICI ≥ 2b revascularization after first aspiration pass
timeFrame: During the procedure
measure: Time from groin puncture to initial contact of clot with aspiration catheter
timeFrame: During the procedure
measure: Time from groin puncture to achieve mTICI ≥ 2b using first line aspiration treatment
timeFrame: During the procedure
measure: Technical success using the MicroVention BOBBY Balloon Guide Catheter based on successful placement at the target location and successful balloon inflation
timeFrame: During the procedure
Other outcomes:
Locations:
city: Burbank
country: United States
facility: Pacific Neuroscience Institute (Providence)
state: California
city: Carmichael
country: United States
facility: Mercy San Juan - Dignity Health Research Institute
state: California
city: Redwood City
country: United States
facility: Kaiser Permanente, Northern California
state: California
city: Colorado Springs
country: United States
facility: UCHealth Memorial
state: Colorado
city: Hollywood
country: United States
facility: Memorial Healthcare System
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Honolulu
country: United States
facility: The Queen's Medical Center
state: Hawaii
city: Rockford
country: United States
facility: Javon Bea Hospital
state: Illinois
city: Carmel
country: United States
facility: Goodman Campbell Brain and Spine
state: Indiana
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's hospital
state: Massachusetts
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Kalamazoo
country: United States
facility: Ascension Borgess
state: Michigan
city: Traverse City
country: United States
facility: Munson Medical Center
state: Michigan
city: Wyoming
country: United States
facility: University of Michigan Health West
state: Michigan
city: Minneapolis
country: United States
facility: Allina Health (Abbott Northwestern Hospital)
state: Minnesota
city: Bridgeton
country: United States
facility: SSM Health
state: Missouri
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Neptune City
country: United States
facility: HMH Jersey Shore University Medical Center
state: New Jersey
city: Bronx
country: United States
facility: Montefiore
state: New York
city: Manhasset
country: United States
facility: Northshore University Hospital - Northwell
state: New York
city: New York City
country: United States
facility: Mt. Sinai Health System
state: New York
city: Stony Brook
country: United States
facility: Stony Brook Medicine
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Toledo
country: United States
facility: ProMedica Toledo
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Science Center
state: Oklahoma
city: Danville
country: United States
facility: Geisinger
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania Health Systems
state: Pennsylvania
city: Greenville
country: United States
facility: Prisma Health Upstate
state: South Carolina
city: Sioux Falls
country: United States
facility: Sanford Medical Center
state: South Dakota
city: Memphis
country: United States
facility: Semmes Murphy Clinic
state: Tennessee
city: Falls Church
country: United States
facility: INOVA
state: Virginia
city: Seattle
country: United States
facility: Swedish Health Services
state: Washington
Study officials:
affiliation: University of Maryland, Baltimore
name: Dheeraj Gandhi, MBBS, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: ProMedica Toledo
name: Syed Zaidi, MD
role: PRINCIPAL_INVESTIGATOR
References: