Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04451525
Other study ID # CL11012
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 15, 2020
Est. completion date December 2025

Study information

Verified date November 2023
Source Microvention-Terumo, Inc.
Contact Michelle Wetherby
Phone 714.920.3815
Email michelle.wetherby@microvention.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Intervention

Device:
MicroVention Mechanical Thrombectomy Devices as first-line treatment
Patient will be treated with mechanical thrombectomy at the direction of the treating physician

Locations

Country Name City State
United States Augusta University Augusta Georgia
United States University of Maryland Baltimore Maryland
United States Brigham and Women's hospital Boston Massachusetts
United States SSM Health Bridgeton Missouri
United States Montefiore Bronx New York
United States Pacific Neuroscience Institute (Providence) Burbank California
United States Goodman Campbell Brain and Spine Carmel Indiana
United States Mercy San Juan - Dignity Health Research Institute Carmichael California
United States University of Cincinnati Cincinnati Ohio
United States Cleveland Clinic Cleveland Ohio
United States UCHealth Memorial Colorado Springs Colorado
United States University of Missouri Columbia Missouri
United States Geisinger Danville Pennsylvania
United States INOVA Falls Church Virginia
United States Prisma Health Upstate Greenville South Carolina
United States Memorial Healthcare System Hollywood Florida
United States Ascension Borgess Kalamazoo Michigan
United States Northshore University Hospital - Northwell Manhasset New York
United States Allina Health (Abbott Northwestern Hospital) Minneapolis Minnesota
United States HMH Jersey Shore University Medical Center Neptune New Jersey
United States University of Oklahoma Health Science Center Oklahoma City Oklahoma
United States University of Nebraska Medical Center Omaha Nebraska
United States University of Pennsylvania Health Systems Philadelphia Pennsylvania
United States Kaiser Permanente, Northern California Redwood City California
United States Javon Bea Hospital Rockford Illinois
United States Washington University Saint Louis Missouri
United States Swedish Health Services Seattle Washington
United States Sanford Medical Center Sioux Falls South Dakota
United States Baystate Medical Center Springfield Massachusetts
United States Stony Brook Medicine Stony Brook New York
United States Tampa General Hospital Tampa Florida
United States ProMedica Toledo Toledo Ohio
United States Munson Medical Center Traverse City Michigan
United States University of Michigan Health West Wyoming Michigan

Sponsors (1)

Lead Sponsor Collaborator
Microvention-Terumo, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cohort I: Proportion of subjects achieving mTICI = 2b revascularization based on independent core lab assessment During the procedure
Secondary Proportion of subjects with good functional outcome defined as mRS = 2 90 days
Secondary Occurrence of procedure related serious adverse events During the procedure through study completion at 90 days
Secondary Occurrence of sICH within 24 hours 24 hours post-operative
Secondary Occurrence of embolization to new territories (ENT) During the procedure
Secondary Presence of vasospasm involving the accessed vascular tree During the procedure through 24 hours post-operative
Secondary Mortality at day 90 90 days post-procedure
Secondary Proportion of subjects achieving mTICI = 2b revascularization after first line aspiration treatment During the procedure
Secondary Number of passes to achieve mTICI = 2b revascularization with first line aspiration treatment During the procedure
Secondary Proportion of subjects achieving mTICI = 2b revascularization after first aspiration pass During the procedure
Secondary Time from groin puncture to initial contact of clot with aspiration catheter During the procedure
Secondary Time from groin puncture to achieve mTICI = 2b using first line aspiration treatment During the procedure
Secondary Technical success using the MicroVention BOBBY Balloon Guide Catheter based on successful placement at the target location and successful balloon inflation During the procedure
See also
  Status Clinical Trial Phase
Recruiting NCT04043052 - Mobile Technologies and Post-stroke Depression N/A
Recruiting NCT03869138 - Alternative Therapies for Improving Physical Function in Individuals With Stroke N/A
Completed NCT04034069 - Effects of Priming Intermittent Theta Burst Stimulation on Upper Limb Motor Recovery After Stroke: A Randomized Controlled Trial N/A
Completed NCT04101695 - Hemodynamic Response of Anodal Transcranial Direct Current Stimulation Over the Cerebellar Hemisphere in Healthy Subjects N/A
Terminated NCT03052712 - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies N/A
Completed NCT00391378 - Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS) N/A
Recruiting NCT06204744 - Home-based Arm and Hand Exercise Program for Stroke: A Multisite Trial N/A
Active, not recruiting NCT06043167 - Clinimetric Application of FOUR Scale as in Treatment and Rehabilitation of Patients With Acute Cerebral Injury
Active, not recruiting NCT04535479 - Dry Needling for Spasticity in Stroke N/A
Completed NCT03985761 - Utilizing Gaming Mechanics to Optimize Telerehabilitation Adherence in Persons With Stroke N/A
Recruiting NCT00859885 - International PFO Consortium N/A
Recruiting NCT06034119 - Effects of Voluntary Adjustments During Walking in Participants Post-stroke N/A
Completed NCT03622411 - Tablet-based Aphasia Therapy in the Chronic Phase N/A
Completed NCT01662960 - Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke N/A
Recruiting NCT05854485 - Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke N/A
Active, not recruiting NCT05520528 - Impact of Group Participation on Adults With Aphasia N/A
Completed NCT03366129 - Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
Completed NCT03281590 - Stroke and Cerebrovascular Diseases Registry
Completed NCT05805748 - Serious Game Therapy in Neglect Patients N/A
Recruiting NCT05621980 - Finger Movement Training After Stroke N/A