ReStore Thrombectomy Trial for Flow Restoration in Acute Ischemic Stroke Patients

Reverse Medical

Status

Suspended

Conditions

Ischemic Stroke

Treatments

Device: thrombectomy (ReStore or Merci)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01437774

112310

Details and patient eligibility

About

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.

Full 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.

Enrollment

210 estimated patients

Sex

All

Ages

22 to 85 years old

Volunteers

No Healthy Volunteers

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.