Ischemic StrokeIMPRESSNCT04663399
IMMunological resPonse Assessment afteR Acute iSchemic Stroke Treated With Endovascular Therapy (IMPRESS)
An observational study of Ischemic Stroke and Thrombectomy, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
IMPRESS study aims to describe the immuno-inflammatory and thrombo-inflammatory profiles during the first 24/36 hours of treatment of patients suffering from AIC treated with TM, and to study the possible impact of these profiles on the functional prognosis at 3 and 12 months of AIC treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Thrombectomy
- What is being tested?
- Prospective patient
- How many people
- 1,200 participants
- Where
- 1 siteFrance
- Study dates
- 23 Feb 2023to 23 May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients referred for a mechanical thrombectomy as part of an acute ischemic stroke will be able to participate in the study.
Who may be able to join
- Patient with an acute ischemic stroke for which treatment with mechanical thrombectomy is indicated, whether or not thrombectomy is performed,
- Having received informed information about the study and having signed a consent to participate in the study (if this is not possible: information and consent of the trusted support person or family member if present; emergency inclusion if absent);
- Affiliated or beneficiary of a social security scheme or equivalent.
- Non inclusion Criteria:
- Pregnant or breast-feeding women
- Patient benefiting from a legal protection measure
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Fondation Adolphe de Rothschild
Paris, Paris, 75019
Amélie YAVCHITZ, MD, PhD, +33 1 48 03 64 54, ayavchitz@for.paris
About this study
Official title: IMMunological resPonse Assessment afteR Acute iSchemic Stroke Treated With Endovascular Therapy
IMPRESS study aims to describe the immuno-inflammatory and thrombo-inflammatory profiles during the first 24/36 hours of treatment of patients suffering from AIC treated with TM, and to study the possible impact of these profiles on the functional prognosis at 3 and 12 months of AIC treatment.
Read the detailed description
Stroke is the second leading cause of death worldwide, the leading cause of acquired disability and the second leading cause of dementia. Ischaemic strokes account for 80% of strokes, 40% of which are caused by occlusion of a large-calibre artery in the polygon of Willis. In 2020, the treatment focuses on recanalisation, as quickly as possible. This is achieved medically by intravenous thrombolysis (IVT) and, since 2015, by mechanical thrombectomy (MT) in cases of proximal anterior artery occlusion. Thrombectomy has revolutionised the management of AIC, as it results in over 90% recanalisation at the end of treatment. However, more than half of patients managed between 3 and 6 hours, and recanalised with TM, remain dependent at 3 months.
In recent years, numerous studies (mainly preclinical) have highlighted the impact of the systemic and cerebral inflammatory reaction following AIC. Interestingly, this immuno-inflammatory reaction seems to follow a precise chronology and involves various immune players. Several preclinical studies in rodents have shown that this immunoinflammatory response appears to be strongly associated with prognosis (final stroke volume, disability and post-stroke dementia).
The absence of reliable biomarkers in humans to better describe and assess the chronology of the immuno-inflammatory profile after stroke appears to be a fundamental limitation to the introduction of innovative treatments. These biomarkers would make it possible to select and accurately assess the time required to introduce treatments such as immunomodulatory therapies (Natalizumab, Fingolimod, Copaxone, cell therapy, etc.). New studies seem necessary to identify peripheral biomarkers of the immuno-inflammatory state (cytokines, precise cell typing), and of thrombo-inflammation (NETose markers, neutrophil markers) and their consequences on disability after an ACI.
The aim of the IMPRESS study is therefore to describe the immuno-inflammatory and thrombo-inflammatory profiles during the first 24 +/-12 hours of the management of patients suffering from AIC treated with TM, and to study the possible impact of these profiles on the functional prognosis 3 and 12 months after the AIC has been managed.
- Conditions
- Ischemic Stroke, Thrombectomy
- Being tested
- Prospective patient
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prospective patientOther
The immuno-inflammatory and thrombo-inflammatory profiles will be evaluated at inclusion, and at 24 hours +/- 12 hours of the reperfusion treatment.
| Study group | Role | What they receive |
|---|---|---|
| Patient with MT | Patients indicated for mechanical thrombectomy and benefiting from the procedure Receives: Other: Prospective patient | |
| Patient without MT | Patients indicated for mechanical thrombectomy but not benefiting from the intervention due to clinical improvement (patients responding to thrombolysis) Receives: Other: Prospective patient |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immuno-inflammatory and thrombo-inflammatory profiles in patients suffering from AIC and treated with mechanical Thrombectomie.
Blood plasma collected from patients at inclusion, and at 24 hours +/- 12 hours of the reperfusion treatment will be used to discover and validate panels of inflammatory biomarkers that are predictive of therapeutic response. The biomarkers will be measured using a multiplex preconfigured panels for inflammatory biomarkers.
Measured: 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start23 Feb 2023
- Primary completion23 May 2028 (estimated)
- Study completion23 May 2028 (estimated)
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.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Benjamin Maier, MD, Principal investigator, Fondation Ophtalmologique Adolphe de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04663399
- Sponsor's protocol ID
- BMR_2020_32
- Acronym
- IMPRESS
- Status last verified
- Jan 2026
- First submitted
- 25 Nov 2020
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMMunological resPonse Assessment afteR Acute iSchemic Stroke Treated With Endovascular Therapy
- ClinicalTrials.gov ID
- NCT04663399
- Acronym / sponsor ID
- IMPRESS / BMR_2020_32
- Conditions
- Ischemic Stroke, Thrombectomy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 23 Feb 2023 (actual)
- Primary completion
- 23 May 2028 (estimated)
- Study completion
- 23 May 2028 (estimated)
- First posted
- 11 Dec 2020 (actual)
- 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.
IMPRESS study aims to describe the immuno-inflammatory and thrombo-inflammatory profiles during the first 24/36 hours of treatment of patients suffering from AIC treated with TM, and to study the possible impact of these profiles on the functional prognosis at 3 and 12 months of AIC treatment.
Detailed description
Stroke is the second leading cause of death worldwide, the leading cause of acquired disability and the second leading cause of dementia. Ischaemic strokes account for 80% of strokes, 40% of which are caused by occlusion of a large-calibre artery in the polygon of Willis. In 2020, the treatment focuses on recanalisation, as quickly as possible. This is achieved medically by intravenous thrombolysis (IVT) and, since 2015, by mechanical thrombectomy (MT) in cases of proximal anterior artery occlusion. Thrombectomy has revolutionised the management of AIC, as it results in over 90% recanalisation at the end of treatment. However, more than half of patients managed between 3 and 6 hours, and recanalised with TM, remain dependent at 3 months.
In recent years, numerous studies (mainly preclinical) have highlighted the impact of the systemic and cerebral inflammatory reaction following AIC. Interestingly, this immuno-inflammatory reaction seems to follow a precise chronology and involves various immune players. Several preclinical studies in rodents have shown that this immunoinflammatory response appears to be strongly associated with prognosis (final stroke volume, disability and post-stroke dementia).
The absence of reliable biomarkers in humans to better describe and assess the chronology of the immuno-inflammatory profile after stroke appears to be a fundamental limitation to the introduction of innovative treatments. These biomarkers would make it possible to select and accurately assess the time required to introduce treatments such as immunomodulatory therapies (Natalizumab, Fingolimod, Copaxone, cell therapy, etc.). New studies seem necessary to identify peripheral biomarkers of the immuno-inflammatory state (cytokines, precise cell typing), and of thrombo-inflammation (NETose markers, neutrophil markers) and their consequences on disability after an ACI.
The aim of the IMPRESS study is therefore to describe the immuno-inflammatory and thrombo-inflammatory profiles during the first 24 +/-12 hours of the management of patients suffering from AIC treated with TM, and to study the possible impact of these profiles on the functional prognosis 3 and 12 months after the AIC has been managed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient with MT | – | Other: Prospective patientPatients indicated for mechanical thrombectomy and benefiting from the procedure |
| Patient without MT | – | Other: Prospective patientPatients indicated for mechanical thrombectomy but not benefiting from the intervention due to clinical improvement (patients responding to thrombolysis) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred for a mechanical thrombectomy as part of an acute ischemic stroke will be able to participate in the study.
Key inclusion criteria (6 listed)
- Patient with an acute ischemic stroke for which treatment with mechanical thrombectomy is indicated, whether or not thrombectomy is performed,
- Having received informed information about the study and having signed a consent to participate in the study (if this is not possible: information and consent of the trusted support person or family member if present; emergency inclusion if absent);
- Affiliated or beneficiary of a social security scheme or equivalent.
- Pregnant or breast-feeding women
- Patient benefiting from a legal protection measure
Key exclusion criteria (1 listed)
- None.
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 |
|---|---|---|
| Prospective patientThe immuno-inflammatory and thrombo-inflammatory profiles will be evaluated at inclusion, and at 24 hours +/- 12 hours of the reperfusion treatment. | Other | Patient with MT, Patient without MT |
Primary outcome
Immuno-inflammatory and thrombo-inflammatory profiles in patients suffering from AIC and treated with mechanical Thrombectomie.
Time frame: 21 months
Blood plasma collected from patients at inclusion, and at 24 hours +/- 12 hours of the reperfusion treatment will be used to discover and validate panels of inflammatory biomarkers that are predictive of therapeutic response. The biomarkers will be measured using a multiplex preconfigured panels for inflammatory biomarkers.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
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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.
Benjamin Maier, MD principal investigator
Fondation Ophtalmologique Adolphe de Rothschild
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke and Thrombectomy, run by Fondation Ophtalmologique Adolphe de Rothschild 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 1 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: looking for participants now, as of the sponsor's last update on 23 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Maier, MD (0148036556, bmaier@for.paris), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immuno-inflammatory and thrombo-inflammatory profiles in patients suffering from AIC and treated with mechanical Thrombectomie. (time frame: 21 months). 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 23 Jan 2026.