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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

This study has suspended participant recruitment.
(DSMB recommendation to suspend trial due to control device)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01437774
First Posted: September 21, 2011
Last Update Posted: September 6, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Reverse Medical Corporation
September 19, 2011
September 21, 2011
September 6, 2012
October 2011
September 2013   (Final data collection date for primary outcome measure)
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

Same as current
Complete list of historical versions of study NCT01437774 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
ReStore Thrombectomy Trial for Flow Restoration in Acute Ischemic Stroke Patients
Prospective Mult-center Randomized Study of the Reverse Medial ReStore Device for Flow Restoration in Arteries of Patients Experiencing Acute Ischemic Stroke
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Ischemic Stroke
Device: thrombectomy (ReStore or Merci)
Each arm will use either ReStore or Merci as the primary thrombectomy device
Other Name: Mechanical Thrombectomy
  • 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
210
October 2013
September 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
22 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01437774
112310
Yes
Not Provided
Not Provided
Reverse Medical Corporation
Reverse Medical Corporation
Not Provided
Principal Investigator: Marilyn M Rymer, MD Mid America Brain and Stroke Institute, St Lukes Hospital, Kansas City MO
Reverse Medical Corporation
September 2012

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