REal-World Analyses of Stroke - Thrombus Occlusion REtrieval

Stroke Clinical Trial

— "RESTORE"  

Official title:

REal-World Analyses of Stroke - Thrombus Occlusion REtrieval

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04451525
• Other study ID #: CL11012
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemia
• Ischemic
• Ischemic Stroke
• Stroke

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