ReStore Thrombectomy Trial for Flow Restoration in Acute Ischemic Stroke Patients

Prospective Mult-center Randomized Study of the Reverse Medial ReStore Device for Flow Restoration in Arteries of Patients Experiencing Acute Ischemic Stroke

The ReStore™ Thrombectomy device restores blood flow in the neurovascular by removing thrombus in patients experiencing ischemic stroke. Patients enrolled in the ReStore Trial will be randomized to treatment with the ReStore™ Thrombectomy Device (investigational treatment) or to treatment with a commercially available thrombectomy device It is expected that the investigational treatment safety profile in terms of clinically significant procedural adverse events will be comparable to the control group.

Study Overview

• Status: Suspended
• Conditions: Ischemic Stroke
• Intervention / Treatment: Device: thrombectomy (ReStore or Merci)

Detailed Description

The objective of this study is to demonstrate substantial equivalence of the ReStore™ Thrombectomy Device with the legally marketed MERCI Retrieval System. The study will evaluate safety and efficacy of the ReStore™ Thrombectomy Device in subjects diagnosed with acute ischemic stroke who require mechanical thrombectomy. All eligible patients will be enrolled and randomized to treatment with either the investigational therapy or the control therapy.

• Study Type: Interventional
• Enrollment (Anticipated): 210
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush Medical Center
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • St Luke's Hospital of Kansas City
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • Tennessee Interventional Associates, Erlanger Medical Ctr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age ≥ 22 and ≤ 85 years
• Clinical signs consistent with the diagnosis of acute ischemic stroke
• Pre-stroke Modified Rankin Score ≤2
• National Institute of Health Stroke Scale (NIHSS) assessment score ≥8 and <30
• Patient presents between 0 and 8 hours of onset of stroke symptoms
• Contraindicated for IV t-PA treatment (as specified by drug manufacturer's IFU) OR Acute ischemic stroke treated with intravenous thrombolytic therapy where vascular imaging (TCD, CTA, MRA, or angiography) shows a persistent occlusion after the end of the infusion treatment. NOTE:
• Treatment initiated within 8 hours after symptom onset (first retrieval pass made within 8 hours)
• Neurologic signs that are NOT rapidly improving (NIHSS score has NOT decreased by 4 or more points as determined prior to or at the time of treatment as compared to the initial screen;
• TIMI 0 or 1 flow in internal carotid, middle cerebral M1/M2 segments, basilar, or vertebral arteries confirmed by angiography which are accessible to the retrieval devices.
• Patient/patient legal authorized representative willing to comply with protocol requirements and return to the treatment center for all required clinical evaluations
• Patient or legally authorized representative has given informed consent, and consent is documented.

Exclusion Criteria:

• NIHSS ≥30 or comatose
• Known to be pregnant
• Serum glucose level <50 mg/dL
• Excessive cervical arterial tortuousity that prevents placement of the retrieval devices
• Known hemorrhagic diathesis
• Patients exhibiting signs suggestive of or angiographic evidence of bilateral stroke
• Coagulation factor deficiency (or oral anticoagulation therapy with INR>3.0)
• In receipt of heparin within 48 hours with a PTT > 2x the lab normal
• Baseline platelets <30,000 mm3
• Known serious sensitivity to intra-arterial radiographic contrast agents
• Severe sustained hypertension (systolic blood pressure > 185 mmHg or diastolic >110 mmHg)
• Baseline CT or MRI revealed significant mass effect with midline shift or greater than 1/3 of the MCA region with hypodensity (sulcal effacement and/or loss of gray-white differentiation is allowed)
• Neurologic signs that are rapidly improving at the time of treatment as measured by a decrease in NIHSS score of 4 or more points as determined prior to or at the time of treatment as compared to the initial screen
• CT or MRI evidence of hemorrhage on presentation
• CT or MRI evidence of mass effect or intracranial tumor (except small meningioma)
• Life expectancy < 3 months
• Angiographic evidence of carotid dissection, or high grade stenosis (> 50% stenosis of the artery proximal to the target vessel) that will prevent access to the clot, or vasculitis
• At the discretion of the investigator, patients with co-morbidities associated with a life expectancy of less than 3 months or co-morbidities that could influence the study results or make clinical follow-up difficult will be excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Concentric Thrombectomy Catheter; Control Arm	Device: thrombectomy (ReStore or Merci); Each arm will use either ReStore or Merci as the primary thrombectomy device; Other Names: Mechanical Thrombectomy
EXPERIMENTAL: Reverse ReStore mechanical thrombectomy; Reverse ReStore Device mechanical thrombectomy Each arm will use either ReStore or Merci as the primary thrombectomy device	Device: thrombectomy (ReStore or Merci); Each arm will use either ReStore or Merci as the primary thrombectomy device; Other Names: Mechanical Thrombectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Primary efficacy endpoint is the achievement of revascularization in the targeted region post-procedure. The primary safety endpoint is the observed rate of clinically significant procedural complications occurring within 24 hours.	Primary Efficacy: The Primary efficacy endpoint is the achievement of revascularization (TIMI grade II or III flow in the targeted region post-procedure. This region is defined as all treatable vessels have to be TIMI II or III These data will be compared to the control group. Primary Safety: The primary safety endpoint is the observed rate of clinically significant procedural complications occurring within 24 hours compared to the control group	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality	The mortality rate for patients whose intracranial vessels are opened by the ReStore device will be compared to those whose vessels are not.	30 and 90 days

Collaborators and Investigators

• Sponsor: Reverse Medical Corporation
• Investigators: Principal Investigator: Marilyn M Rymer, MD, Mid America Brain and Stroke Institute, St Lukes Hospital, Kansas City MO

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (ANTICIPATED): September 1, 2013
• Study Completion (ANTICIPATED): October 1, 2013

Study Registration Dates

• First Submitted: September 19, 2011
• First Submitted That Met QC Criteria: September 20, 2011
• First Posted (ESTIMATE): September 21, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): September 6, 2012
• Last Update Submitted That Met QC Criteria: September 4, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: Acute ischemic stroke
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction
• Other Study ID Numbers: 112310