Endovascular ThrombectomyPhase 2MATRISS-IINCT06700824
A Trial to Assess the Efficacy and Safety of OTR4132-MD in Patients With Acute Ischemic Stroke
A Phase 2 study testing OTR4132 in people with Endovascular Thrombectomy and Ischemic Cerebrovascular Accident, run by Organ, Tissue, Regeneration, Repair and Replacement at 15 sites in France.
Trial summary
The MaTRISS 2 study is a phase 2 randomized, double-blinded and placebo-controlled trial aimed at recruiting 60 subjects (30 placebo and 30 active) from 15 stroke centers in France. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Endovascular Thrombectomy, Ischemic Cerebrovascular Accident
- What is being tested?
- OTR4132
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 15 sitesFrance
- Study dates
- 14 Mar 2025to 26 Mar 2026
- Phase
- Phase 2
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 85 years
- Acute ischemic stroke in anterior circulation territory, identified by magnetic resonance imaging (MRI).
- Occlusion of anterior circulation i.e. carotid artery (ICA) or proximal middle cerebral artery (MCA) (M1 and/or M2 segment)
- Endovascular thrombectomy (with or without previous intravenous thrombolysis)
- Recanalization confirmed by angiography after endovascular treatment: TICI grade 2b - 3
- NIHSS (National Institute of Health Stroke Scale/Score) ≥ 11
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- Pre-stroke modified Rankin Score (mRS): 0 or 1
- Patient* or legally authorized representative (family member or trusted person if patient unable to give consent) or independent physician (if patient unable to give consent and if an authorized representative cannot be reached) has signed informed consent.
- Patients unable to give consent at baseline will go through a deferred consent procedure to continue the study
Who cannot join
- Previous symptomatic stroke with permanent sequelae
- Pre-existing medical, neurological, or psychiatric disease that would confound the neurological evaluation
- Contraindication to MRI
- Stroke lesion not visible on MRI
- History of allergy or anaphylactic reactions to any of the ingredients of OTR4132-MD or heparinoids
- History of hypersensitivity or anaphylactic reactions to iodinated contrast media
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- Intracranial tumor at inclusion
- Pregnant or breastfeeding women
- Severe renal failure with glomerular filtration rate (GFR) < 30 mL/min
- Severe uncontrolled arterial hypertension e.g. systolic blood pressure > 185 mmHg or diastolic blood pressure > 110 mmHg, or intravenous medication necessary to reduce blood pressure
- Life expectancy of less than 3 months or co-morbidities that could influence the study results or would complicate assessment of outcomes (e.g. dementia, psychiatric disease) or would make clinical follow-up difficult
- Increased risk of hemorrhage (for instance medical history of significant bleeding disorders, major surgery or significant trauma in the past 3 months, any history of suspected intracranial hemorrhage, symptoms suggestive of subarachnoid hemorrhage, even if the MRI is normal, international normalized ratio (INR)>1.3 or activated partial thromboplastin time (aPTT)>ULN (upper limit of normal)
- Suspected cerebral vasculitis based on medical history and imaging
- Occlusions in multiple vascular territories
- Evidence of any prior intracranial intervention (i.e. neurosurgery, endovascular intervention)
- Worsening of medical or neurological conditions or per-procedures complications
- Any other serious, advanced, or terminal illness (investigator judgment)
- Current participation in another therapeutic investigation (drug or device)
- The patient is not a member or beneficiary of the French social security system
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
France15 sites
Centre Hospitalier Universi-taire de Bordeaux-Hôpital Pellegrin
Bordeaux, 33076
Centre hospitalier universi-taire de Brest (Cavale Blanche)
Brest, 29609
CHU Henri-Mondor
Créteil, 94000
Centre Hospitalier Universitaire de Martinique
Fort de France, 97261
Centre Hospitalier Universitaire Grenoble Alpes
Grenoble, 38043
Centre Hospitalier Régional Universitaire de Lille- Hôpital Roger Salengro
Lille, 59000
Hôpitaux Universitaires De Marseille Timone-AP-HM
Marseille, 13385
Centre Hospitalier Régional Universitaire de Nancy
Nancy, 54000
UIC Imagerie et Neurovasculaire CHU de Nantes
Nantes, 44093
Hôpital de la Pitié Salpêtrière - AP-HP
Paris, 75013
Hôpital Fondation Adolphe de Rothschild Service de neuro-vasculaire
Paris, 75019
GHU Paris Psychiatrie & Neurosciences
Paris, France
Centre Hospitalier Universitaire de la Guadeloupe
Pointe à Pitre, 97159
Hôpital de Hautepierre
Strasbourg, 67200
Hôpital Foch
Suresnes, 92150
About this study
Official title: MATRISS-II. Matrix Therapy to Reduce Ischemic Stroke Sequelae-II. A Randomized-double Blinded- Placebo Controlled Trial to Assess the Efficacy and Safety of OTR4132-MD in Patients With Acute Ischemic Stroke
The MaTRISS 2 study is a phase 2 randomized, double-blinded and placebo-controlled trial aimed at recruiting 60 subjects (30 placebo and 30 active) from 15 stroke centers in France. The main objective will be to assess the efficacy of OTR4132-MD in patients with anterior ischemic stroke after endovascular thrombectomy. One dose will be tested (2 mg) against placebo. The main outcomes will be NIHSS (neurological score) at 24 hours, rate of intracranial hemorrhages at 24 hours, MRI lesion volume at 3 months and neurological scores at 3 months.
Read the detailed description
- The aim of the study is to confirm previous safety and encouraging efficacy data obtained from the MATRISS first-in man study and animal studies. . This is a prospective double-blinded placebo-controlled trial. The trial will recruit 60 subjects (30 per group) with anterior circulation acute ischemic stroke (AIS) re-vascularized (TICI score 2b - 3) by endovascular thrombectomy. Subjects will be followed for 3 months after a single administration of OTR4132-MD or placebo.
- The study is double blinded and there is no way to distinguish the active product from the placebo. Neither the treating nor evaluating physicians, nor the patients, will be informed of the allocation of the treatment before database lock and the end of the trial.
- The use of a placebo is justified by the absence of any neuroprotector approved in France in this indication so there is no comparator. The administration of OTR4132-MD or Placebo will be done in addition to the best standard of care and does not result in any additional po-tentially harmful procedure.
- The study will include 60 patients (30 in the active group and 30 in the placebo group) which is considered sufficient to demonstrate superiority of treatment over placebo with a 5% risk two-sided level (see sample size calculation).
- The study will evaluate a single dose of OTR4132-MD (2 mg) over Placebo. This dose has been selected as the highest and safest dose tested in the previous MATRISS dose-escalation study.
- A 3 months-follow-up period is estimated sufficient to evaluate the residual disability and is recommended in the guideline "Points to consider on clinical investigation of medicinal products for the treatment of acute stroke" (EMA, 2001, CPMP/EWP/560/98).
- A Data Safety Monitoring Board (DSMB) will be set up. It will consist of three medical experts in neurology and stroke trials. Other relevant expertise will be consulted if deemed neces-sary. The members of the committee will review interim blinded safety and efficacy study da-ta. Unblinding procedures will be set up in individual cases if deemed necessary.
- Being tested
- OTR4132, Placebo
- Keywords
- OTR4132, RGTA, neuroprotective agents, randomized controlled trial, ischemic stroke, endovacular thrombectomy
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OTR4132Device
OTR4132 is a new ReGeneraTing Agent (RGTA®) which is a polymer of glucose (α-1,6 bounds, i.e. dextran backbone) engineered to mimic heparan sulphate (HS) in all three mechanical functions (extracellular matrix scaffold element, protector of matrix pro-teins and cellular communication peptides storage sites) but differ from HS by their resistance to glycanases. OTR4132 allows a restoration of the matrix architecture which secondarily facilitates cell survival and recovery at the site of injury.
PlaceboDevice
saline solution
| Study group | Role | What they receive |
|---|---|---|
| OTR4132 | Experimental | OTR4132 is a new ReGeneraTing Agent (RGTA®) which is a polymer of glucose (α-1,6 bounds, i.e. dextran backbone) engineered to mimic heparan sulphate (HS) in all three mechanical functions (extracellular matrix scaffold element, protector of matrix pro-teins and cellular communication peptides storage sites) but differ from HS by their resistance to glycanases. OTR4132 allows a restoration of the matrix architecture which secondarily facilitates cell survival and recovery at the site of injury. Receives: Device: OTR4132 |
| Placebo | Placebo comparator | Saline solution Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline-Adjusted 24-Hour NIHSS
The NIH Stroke Scale (NIHSS) is based on the collection of 15 clinical neurological items. It allows for an accurate and rapid assessment of observed deficits. A large number of publications have shown that the NIHSS score at 24 hours is the best prognostic factor for long-term functional disability and is closely correlated with disability scores at 3 months. An NIHSS score between 1 and 4 means a minor stroke, between 5 and 15, a moderate stroke, above 15 points, a severe stroke. The maximum score is 42
Measured: 24 hours
Secondary outcomes (4)
Change in modified Rankin scale (mRS) at 3 months
The Modified Rankin Score (mRS) is a 6 point disability scale with possible scores ranging from 0 to 5. A separate category of 6 is usually added for patients who expire. The Modified Rankin Score (mRS) is the most widely used outcome measure in stroke clinical trials. Standardized interviews to obtain a mRS score are recommended at 3 months (90 days) following hospital discharge. The mRS will be used as a continuous endpoint (change in mRS at 3 months and in a responder analysis (mRS 0-2 at 3 months).
Measured: 3 months
Changes in total lesion volume from baseline to 3 months (MRI)
Follow-up infarct volume is a more direct measure of biological effect of treatment. Infarct volume is less likely to be confounded by intervening comorbid illness, rehabilitation therapy, or non-stroke related pathology.
volumetric analyses will be analyzed by an independent core laboratory
Measured: 3 months
The rate of Intracranial hemorrhage at 24-hour
The rate of Intracranial hemorrhage at 24-hour based on Heidelberg classification is considered an important endpoint to assess the potential performance of OTR4132-MD in the repair of the blood brain barrier
Measured: 24 hours
Barthel Index at 3-months
Modified Barthel Index (from 0 to 20) is a measure of physical disability used widely to assess behaviour relating to activities of daily living. It measures what patients do in practice. Assessment is made by anyone who knows the patient well.
100: normal <99 represents slight dependency <90 represents moderate disability <60 represents severe disability >20 represents total dependency
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start14 Mar 2025
- Primary completion18 Nov 2025
- Study completion26 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endovascular ThrombectomyStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organ, Tissue, Regeneration, Repair and Replacement
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Euraxi Pharma
- Responsible party
- Sponsor
- Investigators
- Olivier Detante, MD, Principal investigator, Centre Hospitalier Universitaire Grenoble Alpes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06700824
- Sponsor's protocol ID
- MATRISS-II
- Other IDs
- 2024-A01526-41
- Acronym
- MATRISS-II
- Status last verified
- Jun 2026
- First submitted
- 20 Nov 2024
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MATRISS-II. Matrix Therapy to Reduce Ischemic Stroke Sequelae-II. A Randomized-double Blinded- Placebo Controlled Trial to Assess the Efficacy and Safety of OTR4132-MD in Patients With Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT06700824
- Acronym / sponsor ID
- MATRISS-II / MATRISS-II
- Keywords
- OTR4132, RGTA, neuroprotective agents, randomized controlled trial, ischemic stroke, endovacular thrombectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Organ, Tissue, Regeneration, Repair and ReplacementIndustry (pharma, biotech, devices)
- Collaborators
- Euraxi Pharma
- Study start
- 14 Mar 2025 (actual)
- Primary completion
- 18 Nov 2025 (actual)
- Study completion
- 26 Mar 2026 (actual)
- First posted
- 22 Nov 2024 (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.
The MaTRISS 2 study is a phase 2 randomized, double-blinded and placebo-controlled trial aimed at recruiting 60 subjects (30 placebo and 30 active) from 15 stroke centers in France. The main objective will be to assess the efficacy of OTR4132-MD in patients with anterior ischemic stroke after endovascular thrombectomy. One dose will be tested (2 mg) against placebo. The main outcomes will be NIHSS (neurological score) at 24 hours, rate of intracranial hemorrhages at 24 hours, MRI lesion volume at 3 months and neurological scores at 3 months.
Detailed description
- The aim of the study is to confirm previous safety and encouraging efficacy data obtained from the MATRISS first-in man study and animal studies. . This is a prospective double-blinded placebo-controlled trial. The trial will recruit 60 subjects (30 per group) with anterior circulation acute ischemic stroke (AIS) re-vascularized (TICI score 2b - 3) by endovascular thrombectomy. Subjects will be followed for 3 months after a single administration of OTR4132-MD or placebo.
- The study is double blinded and there is no way to distinguish the active product from the placebo. Neither the treating nor evaluating physicians, nor the patients, will be informed of the allocation of the treatment before database lock and the end of the trial.
- The use of a placebo is justified by the absence of any neuroprotector approved in France in this indication so there is no comparator. The administration of OTR4132-MD or Placebo will be done in addition to the best standard of care and does not result in any additional po-tentially harmful procedure.
- The study will include 60 patients (30 in the active group and 30 in the placebo group) which is considered sufficient to demonstrate superiority of treatment over placebo with a 5% risk two-sided level (see sample size calculation).
- The study will evaluate a single dose of OTR4132-MD (2 mg) over Placebo. This dose has been selected as the highest and safest dose tested in the previous MATRISS dose-escalation study.
- A 3 months-follow-up period is estimated sufficient to evaluate the residual disability and is recommended in the guideline "Points to consider on clinical investigation of medicinal products for the treatment of acute stroke" (EMA, 2001, CPMP/EWP/560/98).
- A Data Safety Monitoring Board (DSMB) will be set up. It will consist of three medical experts in neurology and stroke trials. Other relevant expertise will be consulted if deemed neces-sary. The members of the committee will review interim blinded safety and efficacy study da-ta. Unblinding procedures will be set up in individual cases if deemed necessary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OTR4132 | Experimental | Device: OTR4132OTR4132 is a new ReGeneraTing Agent (RGTA®) which is a polymer of glucose (α-1,6 bounds, i.e. dextran backbone) engineered to mimic heparan sulphate (HS) in all three mechanical functions (extracellular matrix scaffold element, protector of matrix pro-teins and cellular communication peptides storage sites) but differ from HS by their resistance to glycanases. OTR4132 allows a restoration of the matrix architecture which secondarily facilitates cell survival and recovery at the site of injury. |
| Placebo | Placebo comparator | Device: PlaceboSaline solution |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age between 18 and 85 years
- Acute ischemic stroke in anterior circulation territory, identified by magnetic resonance imaging (MRI).
- Occlusion of anterior circulation i.e. carotid artery (ICA) or proximal middle cerebral artery (MCA) (M1 and/or M2 segment)
- Endovascular thrombectomy (with or without previous intravenous thrombolysis)
- Recanalization confirmed by angiography after endovascular treatment: TICI grade 2b - 3
Key exclusion criteria (19 listed)
- Previous symptomatic stroke with permanent sequelae
- Pre-existing medical, neurological, or psychiatric disease that would confound the neurological evaluation
- Contraindication to MRI
- Stroke lesion not visible on MRI
- History of allergy or anaphylactic reactions to any of the ingredients of OTR4132-MD or heparinoids
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 |
|---|---|---|
| OTR4132OTR4132 is a new ReGeneraTing Agent (RGTA®) which is a polymer of glucose (α-1,6 bounds, i.e. dextran backbone) engineered to mimic heparan sulphate (HS) in all three mechanical functions (extracellular matrix scaffold element, protector of matrix pro-teins and cellular communication peptides storage sites) but differ from HS by their resistance to glycanases. OTR4132 allows a restoration of the matrix architecture which secondarily facilitates cell survival and recovery at the site of injury. | Device | OTR4132 |
| Placebosaline solution | Device | Placebo |
Primary outcome
Baseline-Adjusted 24-Hour NIHSS
Time frame: 24 hours
The NIH Stroke Scale (NIHSS) is based on the collection of 15 clinical neurological items. It allows for an accurate and rapid assessment of observed deficits. A large number of publications have shown that the NIHSS score at 24 hours is the best prognostic factor for long-term functional disability and is closely correlated with disability scores at 3 months. An NIHSS score between 1 and 4 means a minor stroke, between 5 and 15, a moderate stroke, above 15 points, a severe stroke. The maximum score is 42
4 secondary outcomes
Change in modified Rankin scale (mRS) at 3 months
Time frame: 3 months
Changes in total lesion volume from baseline to 3 months (MRI)
Time frame: 3 months
The rate of Intracranial hemorrhage at 24-hour
Time frame: 24 hours
Barthel Index at 3-months
Time frame: 3 months
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 26 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
Olivier Detante, MD principal investigator
Centre Hospitalier Universitaire Grenoble Alpes
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OTR4132 in people with Endovascular Thrombectomy and Ischemic Cerebrovascular Accident, run by Organ, Tissue, Regeneration, Repair and Replacement at 15 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 9 inclusion and 19 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 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Baseline-Adjusted 24-Hour NIHSS (time frame: 24 hours). 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 26 Jun 2026.