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Trial record 1 of 1 for:    NCT01437774
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ReStore Thrombectomy Trial for Flow Restoration in Acute Ischemic Stroke Patients

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ClinicalTrials.gov Identifier: NCT01437774
Recruitment Status : Suspended (DSMB recommendation to suspend trial due to control device)
First Posted : September 21, 2011
Last Update Posted : September 6, 2012
Sponsor:
Information provided by (Responsible Party):
Reverse Medical Corporation

Tracking Information
First Submitted Date  ICMJE September 19, 2011
First Posted Date  ICMJE September 21, 2011
Last Update Posted Date September 6, 2012
Study Start Date  ICMJE October 2011
Estimated Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 20, 2011)
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 ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01437774 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 20, 2011)
mortality [ Time Frame: 30 and 90 days ]
The mortality rate for patients whose intracranial vessels are opened by the ReStore device will be compared to those whose vessels are not.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE ReStore Thrombectomy Trial for Flow Restoration in Acute Ischemic Stroke Patients
Official Title  ICMJE Prospective Mult-center Randomized Study of the Reverse Medial ReStore Device for Flow Restoration in Arteries of Patients Experiencing Acute Ischemic Stroke
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.
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  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Ischemic Stroke
Intervention  ICMJE Device: thrombectomy (ReStore or Merci)
Each arm will use either ReStore or Merci as the primary thrombectomy device
Other Name: Mechanical Thrombectomy
Study Arms
  • Active Comparator: Concentric Thrombectomy Catheter
    Control Arm
    Intervention: Device: thrombectomy (ReStore or Merci)
  • Experimental: Reverse ReStore mechanical thrombectomy
    Reverse ReStore Device mechanical thrombectomy Each arm will use either ReStore or Merci as the primary thrombectomy device
    Intervention: Device: thrombectomy (ReStore or Merci)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: September 20, 2011)
210
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date October 2013
Estimated Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 22 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01437774
Other Study ID Numbers  ICMJE 112310
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Reverse Medical Corporation
Study Sponsor  ICMJE Reverse Medical Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marilyn M Rymer, MD Mid America Brain and Stroke Institute, St Lukes Hospital, Kansas City MO
PRS Account Reverse Medical Corporation
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP