ReStore Thrombectomy Trial for Flow Restoration in Acute Ischemic Stroke Patients

NCT01437774 | Suspended DMC

• 1 other identifier: 112310
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Ischemic Stroke

Keywords

Acute ischemic stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• mortality

  30 and 90 days

Study Arms (2)

Concentric Thrombectomy Catheter

ACTIVE COMPARATOR

Control Arm

Device: thrombectomy (ReStore or Merci)

Reverse ReStore mechanical thrombectomy

EXPERIMENTAL

Reverse ReStore Device mechanical thrombectomy Each arm will use either ReStore or Merci as the primary thrombectomy device

Device: thrombectomy (ReStore or Merci)

Interventions

thrombectomy (ReStore or Merci) DEVICE

Each arm will use either ReStore or Merci as the primary thrombectomy device

Also known as: Mechanical Thrombectomy

Concentric Thrombectomy Catheter; Reverse ReStore mechanical thrombectomy

Eligibility Criteria

• Age: 22 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Reverse Medical Corporation: lead

Study Sites (4)

Rush Medical Center

Chicago, Illinois, 60612, United States

Location

St Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Tennessee Interventional Associates, Erlanger Medical Ctr

Chattanooga, Tennessee, 37403, United States

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Thrombectomy

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Marilyn M Rymer, MD

  Mid America Brain and Stroke Institute, St Lukes Hospital, Kansas City MO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2011
• First Posted: September 21, 2011
• Study Start: October 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: October 1, 2013
• Last Updated: September 6, 2012

Record last verified: 2012-09

Locations

US (4)