StrokeRe-ACTNCT02169492
Evaluation of the ReVive SE Device for Intra-Arterial Thrombectomy in Acute Ischemic Stroke
An observational study of Stroke, run by Codman & Shurtleff at 8 sites in France.
Trial summary
The main objective of this study is to assess the safety and effectiveness of the ReVive SE (Self- Expanding) Neurothrombectomy Device in subjects requiring mechanical thrombectomy when used according to its Instruction for use (IFU). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- How many people
- 103 participants
- Where
- 8 sitesFrance
- Study dates
- 1 Jan 2015to 31 May 2017
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: subjects requiring mechanical thrombectomy
Who may be able to join
- Age ≥ 18 years old
- Clinical signs consistent with acute ischemic stroke
- No pre-stroke functional dependence (pre-stroke Modified Rankin Score ≤ 1)
- NIHSS ≥ 6,, assessed within two hours before treatment with ReVive SE
- Large (≥ 1.5mm) and proximal vessel occlusion (presenting TICI score of 0 or 1) of MCA (M1-M2), dICA, or BA confirmed by CT/MR angiography that it is accessible to the ReVive SE.
- Treatment initiated within 8 hours after symptom onset (first ReVive SE pass made within 6 hours
- Subject or legally authorized representative has provided informed consent on data collection, and consent is documented
Who cannot join
- Life expectancy of less than 90 days
- Neurological signs that are rapidly improving prior to or at time of treatment (NIHSS improves at least 4 points between subject presentation and treatment initiation)
- Subject is either exhibiting clinical signs suggestive of, or there is angiographic evidence of bilateral stroke
- Prior use of any other mechanical device to treat this stroke (e.g., Merci Retriever, Penumbra, Solitaire, Trevo, Mindframe, Phenox, stent)
- Known bleeding diathesis:
- Current use of oral anticoagulants (eg, warfarin sodium) with International Normalized Ratio (INR) > 3;
Show all 17Show fewer
- Administration of heparin or Novel Oral AntiCoagulants (NOAC, eg Dabigatran, Rivaroxaban) within 48 hours preceding the onset of stroke and have an abnormal activated partial thromboplastin time (aPTT) at presentation; and/or
- Platelet count < 100,000/mm3
- Glucose <50 mg/dL (2.8 mmol, 2.6mM)
- Uncontrolled hypertension (SBP>185 or DBP>110) refractory to pharmacological management
- Known hypersensitivity or allergy to nitinol and/or radiographic contrast agents
- Pregnancy or lactating female
- Subject already enrolled in a clinical study involving experimental medication or device
- Imaging Exclusion criteria:
- CT scan or MRI with evidence of acute intracranial hemorrhage, mass effect and/or intracranial tumor.
- 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 cerebral vasculitis
- Blood vessel with extreme tortuosity or other conditions preventing the access of the device.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
CHU Bordeaux
Bordeaux
CHU Clermont Ferrand
Clermont-Ferrand
CHU de Colmar
Colmar
CHU Dijon
Dijon
CHU Lille
Lille
CHU La Timone
Marseille
CHU St Etienne
Saint-Etienne
Hôpital Bretonneau
Tours
About this study
Official title: Evaluation of the ReVive SE Device for Intra-Arterial Thrombectomy in Acute Ischemic Stroke: An Observational, Prospective and Multicenter Study
The main objective of this study is to assess the safety and effectiveness of the ReVive SE (Self- Expanding) Neurothrombectomy Device in subjects requiring mechanical thrombectomy when used according to its Instruction for use (IFU).
- Conditions
- Stroke
- Keywords
- Thrombectomy, Stroke, ReVive SE
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Rankin Scale
Functional Independence of subjects as defined by modified Rankin Scale (mRS) ≤2 at 90 days post-procedure.
Measured: 90 days
Secondary outcomes (1)
National Institute of Health Stroke Scale (NIHSS)
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study start1 Jan 2015
- Primary completion31 May 2017
- Study completion31 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 103 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Codman & Shurtleff
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Benjamin Hoehn, MD, Study director, Codman Neuro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02169492
- Sponsor's protocol ID
- NV-PMK-1203
- Acronym
- Re-ACT
- Status last verified
- Aug 2017
- First submitted
- 13 Jun 2014
- Last updated
- 7 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the ReVive SE Device for Intra-Arterial Thrombectomy in Acute Ischemic Stroke: An Observational, Prospective and Multicenter Study
- ClinicalTrials.gov ID
- NCT02169492
- Acronym / sponsor ID
- Re-ACT / NV-PMK-1203
- Conditions
- Stroke
- Keywords
- Thrombectomy, Stroke, ReVive SE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (estimated)
- Lead sponsor
- Codman & ShurtleffIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 23 Jun 2014 (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 main objective of this study is to assess the safety and effectiveness of the ReVive SE (Self- Expanding) Neurothrombectomy Device in subjects requiring mechanical thrombectomy when used according to its Instruction for use (IFU).
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- subjects requiring mechanical thrombectomy
Key inclusion criteria (7 listed)
- Age ≥ 18 years old
- Clinical signs consistent with acute ischemic stroke
- No pre-stroke functional dependence (pre-stroke Modified Rankin Score ≤ 1)
- NIHSS ≥ 6,, assessed within two hours before treatment with ReVive SE
- Large (≥ 1.5mm) and proximal vessel occlusion (presenting TICI score of 0 or 1) of MCA (M1-M2), dICA, or BA confirmed by CT/MR angiography that it is accessible to the ReVive SE.
Key exclusion criteria (17 listed)
- Life expectancy of less than 90 days
- Neurological signs that are rapidly improving prior to or at time of treatment (NIHSS improves at least 4 points between subject presentation and treatment initiation)
- Subject is either exhibiting clinical signs suggestive of, or there is angiographic evidence of bilateral stroke
- Prior use of any other mechanical device to treat this stroke (e.g., Merci Retriever, Penumbra, Solitaire, Trevo, Mindframe, Phenox, stent)
- Known bleeding diathesis:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
modified Rankin Scale
Time frame: 90 days
Functional Independence of subjects as defined by modified Rankin Scale (mRS) ≤2 at 90 days post-procedure.
1 secondary outcome
National Institute of Health Stroke Scale (NIHSS)
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2017.
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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.
Benjamin Hoehn, MD study director
Codman Neuro
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Codman & Shurtleff at 8 sites in France.
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 7 inclusion and 17 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: finished, as of the sponsor's last update on 7 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
modified Rankin Scale (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 7 Aug 2017; AzTrials last refreshed its copy on 7 Nov 2026.