ReStore Thrombectomy Trial for Flow Restoration in Acute Ischemic Stroke Patients

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01437774
• Other study ID #: 112310
• Status: Suspended
• Phase: N/A
• First received: September 19, 2011
• Last updated: September 4, 2012
• Start date: October 2011
• Est. completion date: October 2013

Study information

• Verified date: September 2012
• Source: Reverse Medical Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 210
• Est. completion date: October 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 22 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Device:
• thrombectomy (ReStore or Merci)
Each arm will use either ReStore or Merci as the primary thrombectomy device

Locations

Country	Name	City	State
United States	Tennessee Interventional Associates, Erlanger Medical Ctr	Chattanooga	Tennessee
United States	Rush Medical Center	Chicago	Illinois
United States	St Luke's Hospital of Kansas City	Kansas City	Missouri
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Reverse Medical Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes