StrokeREVIVE SENCT02971826
Use of the Thrombectomy Device ReVive™ SE in the Acute Treatment of Stroke
A study testing REVIVETM SE thrombectomy in people with Stroke, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The last marketed thrombectomy devices, named stentretriever, permit a better and faster recanalization in patient with a stroke. The REVIVETM SE is a device designed to restore the brain perfusion in patient with an intracranial artery occlusion. The REVIVETM Se device is not widely use in Europe and in France. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- REVIVETM SE thrombectomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- 30 Nov 2018to 1 Jun 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with an ischemic stroke detected by Computed Tomography (CT) or Magnetic Resonance Image (MRI)
- Large proximal arterial occlusion : M1 segment of the Middle cerebral artery (MCA), Internal Carotid Artery (ICA) or Basilar Artery (BA)
- Last known well (without neurological symptoms) ≤ 8 hours of treatment initiation
- Score NIHSS ≥4
- Eligibility on an endovascular procedure using REVIVETM SE device
- No opposition of the patient to participate at the study
Who cannot join
- Diagnostic cerebral imaging impossible
- Distal occlusion
- Tortuous vessel or other specificity preventing the access of device
- Vessel diameter < 1.5 mm
- Known hypersensibility or allergy to nitinol
- Subjects not covered by or having the right to social security
- Deprivation of civil rights (guardianship, safeguard justice)
Trial locations and contacts
1 site in 1 country.
About this study
The last marketed thrombectomy devices, named stentretriever, permit a better and faster recanalization in patient with a stroke. The REVIVETM SE is a device designed to restore the brain perfusion in patient with an intracranial artery occlusion. The REVIVETM Se device is not widely use in Europe and in France. The objective of this study is to assess the interest of using this device in the standard care of ischemic stroke in the radiology unit of the hospital Pierre Wertheimer, Lyon. The medical care will not be modified but data will be collected in order to determine whether or not this device is useful for the practice of the radiology unit.
- Conditions
- Stroke
- Being tested
- REVIVETM SE thrombectomy
- Keywords
- Stroke, thrombectomy, REVIVETM SE, MRI, Computed Tomography
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REVIVETM SE thrombectomyDevice
Mechanical thrombectomy using the REVIVETM SE device in patient with an ischemic stroke due to an intracranial arterial occlusion
| Study group | Role | What they receive |
|---|---|---|
| Thrombectomy using the REVIVETM SE device | Experimental | Thrombectomy using the REVIVETM SE device in patient with an ischemic stroke Receives: Device: REVIVETM SE thrombectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients with a TICI score of 2b or 3 just after the thrombectomy
The TICI score is a grading system which evaluate the degree of reperfusion as seen on arteriography
Measured: up to 2 days
Secondary outcomes (3)
Number of the other devices use during the thrombectomy (Gidewire, catheter, etc.)
Review of the medical report which collected the devices used
Measured: up to 2 days
Number of other procedures to treat the patient (thrombolysis, thromboaspiration, etc)
Review of the medical report which collected the acute treatments
Measured: Day 0
Time to obtain the appropriate recanalization (TICI 2b or 3)
Time of recanalization reported by the investigator on the medical report
Measured: At the end of the procedure - Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2016 (estimated)
- Study start30 Nov 2018
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
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.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Françis TURJMAN, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02971826
- Sponsor's protocol ID
- 69HCL16_0571
- Other IDs
- 2016-A01470-51
- Acronym
- REVIVE SE
- Status last verified
- Dec 2025
- First submitted
- 16 Nov 2016
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the Thrombectomy Device ReVive™ SE in the Acute Treatment of Stroke
- ClinicalTrials.gov ID
- NCT02971826
- Acronym / sponsor ID
- REVIVE SE / 69HCL16_0571
- Conditions
- Stroke
- Keywords
- Stroke, thrombectomy, REVIVETM SE, MRI, Computed Tomography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 30 Nov 2018 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 23 Nov 2016 (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 last marketed thrombectomy devices, named stentretriever, permit a better and faster recanalization in patient with a stroke. The REVIVETM SE is a device designed to restore the brain perfusion in patient with an intracranial artery occlusion. The REVIVETM Se device is not widely use in Europe and in France. The objective of this study is to assess the interest of using this device in the standard care of ischemic stroke in the radiology unit of the hospital Pierre Wertheimer, Lyon. The medical care will not be modified but data will be collected in order to determine whether or not this device is useful for the practice of the radiology unit.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thrombectomy using the REVIVETM SE device | Experimental | Device: REVIVETM SE thrombectomyThrombectomy using the REVIVETM SE device in patient with an ischemic stroke |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient with an ischemic stroke detected by Computed Tomography (CT) or Magnetic Resonance Image (MRI)
- Large proximal arterial occlusion : M1 segment of the Middle cerebral artery (MCA), Internal Carotid Artery (ICA) or Basilar Artery (BA)
- Last known well (without neurological symptoms) ≤ 8 hours of treatment initiation
- Score NIHSS ≥4
- Eligibility on an endovascular procedure using REVIVETM SE device
Key exclusion criteria (7 listed)
- Diagnostic cerebral imaging impossible
- Distal occlusion
- Tortuous vessel or other specificity preventing the access of device
- Vessel diameter < 1.5 mm
- Known hypersensibility or allergy to nitinol
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 |
|---|---|---|
| REVIVETM SE thrombectomyMechanical thrombectomy using the REVIVETM SE device in patient with an ischemic stroke due to an intracranial arterial occlusion | Device | Thrombectomy using the REVIVETM SE device |
Primary outcome
number of patients with a TICI score of 2b or 3 just after the thrombectomy
Time frame: up to 2 days
The TICI score is a grading system which evaluate the degree of reperfusion as seen on arteriography
3 secondary outcomes
Number of the other devices use during the thrombectomy (Gidewire, catheter, etc.)
Time frame: up to 2 days
Number of other procedures to treat the patient (thrombolysis, thromboaspiration, etc)
Time frame: Day 0
Time to obtain the appropriate recanalization (TICI 2b or 3)
Time frame: At the end of the procedure - Day 0
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 19 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Françis TURJMAN principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REVIVETM SE thrombectomy in people with Stroke, run by Hospices Civils de Lyon at 1 site 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 6 inclusion and 7 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 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
number of patients with a TICI score of 2b or 3 just after the thrombectomy (time frame: up to 2 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 19 Dec 2025.