Ischemic StrokeNCT01437774
ReStore Thrombectomy Trial for Flow Restoration in Acute Ischemic Stroke Patients
A study testing thrombectomy (ReStore or Merci) in people with Ischemic Stroke, run by Reverse Medical Corporation at 4 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 22 to 85 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- thrombectomy (ReStore or Merci)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2011to Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Tennessee Interventional Associates, Erlanger Medical Ctr
Chattanooga, Tennessee, 37403
Rush Medical Center
Chicago, Illinois, 60612
St Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: 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.
Read the 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.
- Conditions
- Ischemic Stroke
- Being tested
- thrombectomy (ReStore or Merci)
- Keywords
- Acute ischemic stroke
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thrombectomy (ReStore or Merci)Device
Also called Mechanical Thrombectomy
Each arm will use either ReStore or Merci as the primary thrombectomy device
| Study group | Role | What they receive |
|---|---|---|
| Concentric Thrombectomy Catheter | Active comparator | Control Arm Receives: 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 Receives: Device: thrombectomy (ReStore or Merci) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 90 days
Secondary outcomes (1)
mortality
The mortality rate for patients whose intracranial vessels are opened by the ReStore device will be compared to those whose vessels are not.
Measured: 30 and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2011 (estimated)
- Study startOct 2011
- Primary completionSep 2013 (estimated)
- Study completionOct 2013 (estimated)
Why it stopped: DSMB recommendation to suspend trial due to control device
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Reverse Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marilyn M Rymer, MD, Principal investigator, Mid America Brain and Stroke Institute, St Lukes Hospital, Kansas City MO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01437774
- Sponsor's protocol ID
- 112310
- Status last verified
- Sep 2012
- First submitted
- 19 Sep 2011
- Last updated
- 6 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Mult-center Randomized Study of the Reverse Medial ReStore Device for Flow Restoration in Arteries of Patients Experiencing Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT01437774
- Acronym / sponsor ID
- 112310
- Conditions
- Ischemic Stroke
- Keywords
- Acute ischemic stroke
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: DSMB recommendation to suspend trial due to control device
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Reverse Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Oct 2013 (estimated)
- First posted
- 21 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concentric Thrombectomy Catheter | Active comparator | Device: thrombectomy (ReStore or Merci)Control Arm |
| Reverse ReStore mechanical thrombectomy | Experimental | Device: thrombectomy (ReStore or Merci)Reverse ReStore Device mechanical thrombectomy Each arm will use either ReStore or Merci as the primary thrombectomy device |
Who may qualify
- Ages
- 22 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| thrombectomy (ReStore or Merci)Also: Mechanical ThrombectomyEach arm will use either ReStore or Merci as the primary thrombectomy device | Device | Concentric Thrombectomy Catheter, Reverse ReStore mechanical thrombectomy |
Primary outcome
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
1 secondary outcome
mortality
Time frame: 30 and 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marilyn M Rymer, MD principal investigator
Mid America Brain and Stroke Institute, St Lukes Hospital, Kansas City MO
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing thrombectomy (ReStore or Merci) in people with Ischemic Stroke, run by Reverse Medical Corporation at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 6 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2012.