ReStore Thrombectomy Trial for Flow Restoration in Acute Ischemic Stroke Patients

This study has suspended participant recruitment.
(DSMB recommendation to suspend trial due to control device)
Sponsor:
Information provided by (Responsible Party):
Reverse Medical Corporation
ClinicalTrials.gov Identifier:
NCT01437774
First received: September 19, 2011
Last updated: September 4, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Ischemic Stroke
Device: thrombectomy (ReStore or Merci)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective Mult-center Randomized Study of the Reverse Medial ReStore Device for Flow Restoration in Arteries of Patients Experiencing Acute Ischemic Stroke

Resource links provided by NLM:


Further study details as provided by Reverse Medical Corporation:

Primary Outcome Measures:
  • 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. [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

    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



Secondary Outcome Measures:
  • mortality [ Time Frame: 30 and 90 days ] [ Designated as safety issue: Yes ]
    The mortality rate for patients whose intracranial vessels are opened by the ReStore device will be compared to those whose vessels are not.


Estimated Enrollment: 210
Study Start Date: October 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Mechanical Thrombectomy

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.

  Eligibility

Ages Eligible for Study:   22 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01437774

Locations
United States, Illinois
Rush Medical Center
Chicago, Illinois, United States, 60612
United States, Missouri
St Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64111
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Tennessee
Tennessee Interventional Associates, Erlanger Medical Ctr
Chattanooga, Tennessee, United States, 37403
Sponsors and Collaborators
Reverse Medical Corporation
Investigators
Principal Investigator: Marilyn M Rymer, MD Mid America Brain and Stroke Institute, St Lukes Hospital, Kansas City MO
  More Information

No publications provided

Responsible Party: Reverse Medical Corporation
ClinicalTrials.gov Identifier: NCT01437774     History of Changes
Other Study ID Numbers: 112310
Study First Received: September 19, 2011
Last Updated: September 4, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Reverse Medical Corporation:
Acute ischemic stroke

Additional relevant MeSH terms:
Ischemia
Stroke
Cerebral Infarction
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on July 23, 2014