AzTrials
AzTrials

Stroke, AcuteMATRISSNCT04083001

An Open, Study to Assess the Safety of RGTA® (OTR4132) in Patients With Acute Ischemic Stroke (AIS)

A study testing OTR4132MD in people with Stroke, Acute, run by Organ, Tissue, Regeneration, Repair and Replacement at 3 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

RGTA® (ReGeneraTing Agent) are synthetic polysaccharides mimicking extra-cellular matrix scaffold elements and protective agents called Heparan Sulphates (HSPGs). OTR4132-MD is provided as a sterile injectable medical device. Read more about this study

Who is it for?
Ages 45 to 80 years
Conditions the study is for
Stroke, Acute
What is being tested?
OTR4132MD
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
3 sitesFrance
Study dates
3 Mar 2022to 19 Jun 2024
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 45 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Eligible patients for this study will be included if all of the following conditions are met:
  • Age between 45 and 80 years
  • Acute ischemic stroke in anterior circulation territory, identified by magnetic resonance imaging (MRI)
  • Occlusion of anterior circulation i.e. internal carotid artery (ICA) or proximal middle cerebral artery (MCA) (M1 and/or M2 segment)
  • Volume of the infarcted lesion estimated below two thirds of the MCA territory (diffusion MRI sequence)
  • Endovascular thrombectomy initiated within 6 hours of stroke onset with known stroke onset time or Endovascular thrombectomy initiated within 6 to 16 hours of symptoms onset (last know well in case of unwitnessed onset) with a mismatch on brain MRI defined in *.
Show all 15Show fewer
  • Recanalization confirmed by angiography after endovascular treatment: TICI grade 2b - 3
  • NIHSS at pre-screening (National Institute of Health Stroke Scale/Score), including hand testing: between 11 and 25
  • No significant pre-stroke disability (pre-stroke modified Rankin Score (mRS): 0-1
  • Able to follow neuro-rehabilitation programme
  • 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).
  • Perfusion core/penumbra mismatch:
  • Infarct core volume <70 mL
  • and critically hypoperfused volume/infarct core volume >1.8
  • and mismatch volume >15mL ** Patients unable to give consent at baseline will go through a deferred consent procedure to continue the study

Who cannot join

  • Eligible patients for this study will not be included if any of the following conditions are present:
  • Previous symptomatic stroke
  • Pre-existing medical, neurological, or psychiatric disease that would confound the neurological evaluation
  • Contra-indication to MRI
  • Evidence of intracranial haemorrhage (ICH)
  • 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 would complicate assessment of outcomes (e.g. dementia, psychiatric disease) or would make clinical follow-up difficult
Show all 20Show fewer
  • 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
  • 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
  • Increased risk of haemorrhage (such as medical history of significant bleeding disorders, major surgery or significant trauma in the past 3 months, any history of central nervous damage or suspected intracranial haemorrhage, symptoms suggestive of subarachnoid haemorrhage, 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 intracranial tumour
  • 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)
  • Pregnant or breastfeeding or women without an adequate contraceptive method
  • Current participation in another investigation drug or device study
  • The patient is not a member or beneficiary of the French social security system

Trial locations and contacts

3 sites in 1 country.

France3 sites

  • CHU Bordeaux Pellegrin

    Bordeaux, New Aquitaine, 33000

  • CHU Grenoble Alpes

    Grenoble, Auvergne-Rhône-Alpes, 38000

  • CHU Nancy

    Nancy, Grand Est, 54000

Other trials in France

About this study

Official title: An Open, Multi-centre Study to Assess the Safety and Tolerability of RGTA® (OTR4132) in Patients With Acute Ischemic Stroke (AIS)

RGTA® (ReGeneraTing Agent) are synthetic polysaccharides mimicking extra-cellular matrix scaffold elements and protective agents called Heparan Sulphates (HSPGs).

OTR4132-MD is provided as a sterile injectable medical device. OTR4132-MD is indicated in anterior circulation acute ischemic stroke (AIS) patients re-vascularized (TICI score 2b - 3) by endovascular thrombectomy combined or not with thrombolysis.

Read the detailed description

The promising results of OTR4132-MD in the treatment of acute ischemic stroke in animal studies and the excellent results of biocompatibility tests reported in the Investigator's Brochure allowed to design a clinical investigation in humans named MATRISS. As this is a First-In-Man (FIM) study assessing OTR4132-MD, it is designed as a single ascending dose (SAD) to evaluate the safety, tolerability of a single intra-arterial injection of OTR4132-MD in AIS patients treated with thrombectomy combined or not with thrombolysis.

The FIM will include up to 19 patients in up to six dose groups. Each group will comprise 3 subjects. This FIM study will also monitor a dose response relationship in humans: lesion volume change throughout the study period. Patients will be given a single intra-arterial injection of OTR4132-MD with a predefined dose of OTR4132. In the first dose group, the OTR4132 dose is 0.20 mg.

The results of this study will serve as a groundwork for the design of a pivotal study in the intended patient population.

Conditions
Stroke, Acute
Being tested
OTR4132MD
Keywords
Stroke, FIM, OTR3
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OTR4132MDDevice

    According to Regulation (EU) 2017/745(MDR), OTR4132-MD is an implantable medical device, for short term use which is specifically intended for use in direct contact with systemic circulation system.

    OTR4132-MD is by definition intended to come into contact with the patient when being injected. It is administered through intra-arterial injection, in an one-shot dose and the majority of the product is eliminated within 24 hours.

Study groups in NCT04083001
Study groupRoleWhat they receive
OTR4132MDExperimentalOne medical device will be administrated as a one shot-dose to the patient. The respective total dose of OTR4132 received by a patient will be one of the following: 0,20 mg, 0,50 mg, 1 mg, 1,5 mg, 2 mg and 2,5 mg.
Receives: Device: OTR4132MD

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of severe adverse events device related and dose limiting

    Severe adverse events

    Measured: 7 Days

Secondary outcomes (8)

  1. Survival rates

    survival rates

    Measured: 24 hours, 7 Days, 30 Days, 90 Days

  2. All cause death

    All cause death

    Measured: 24 hours, 7 Days, 30 Days, 90 Days

  3. Stroke related death

    Stroke related death

    Measured: 24 hours, 7 Days, 30 Days, 90 Days

  4. Rate of device related adverse events (AEs) and serious adverse events (SAEs)

    rate of device related adverse events

    Measured: 24 hours, 7 Days, 30 Days, 90 Days

  5. Rate of adverse events (AEs) and serious adverse events (SAEs) procedure related

    Rate of AEs and SAEs propcedure related

    Measured: 24 hours, 7 Days, 30 Days, 90 Days

  6. Symptomatic intracranial haemorrhage

    Intracranial haemorrhage

    Measured: 24 hours, 7 Days, 30 Days, 90 Days

  7. Brain oedema on 24-hour follow-up imaging

    brain oedema

    Measured: 24 hours

  8. New ischaemic lesions

    Ischaemic lesions in new territories on 24-hours follow-up imaging

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2019
  2. Study start3 Mar 2022
  3. Primary completion19 Jun 2024
  4. Study completion19 Jun 2024

Resources

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
Not applicable
Intervention model
Single group
Model description
open study
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04083001
Sponsor's protocol ID
2018-A03117-48
Acronym
MATRISS
Status last verified
Jul 2024
First submitted
3 Sep 2019
Last updated
2 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Barreau X, Anxionnat R, Heck O, Sibon I, Rosso C, Oppenheim C, Moniche F, Sedel F, Chiappini F, Choppin A, Inizan M, Barritault D, Detante O. Intra-arterial Injection of OTR4132, a Novel Neuroprotector in Acute Ischemic Stroke: The MaTRISS Trial. Clin Drug Investig. 2025 Nov;45(11):877-887. doi: 10.1007/s40261-025-01487-y. Epub 2025 Oct 2.

    PubMed 41037228

Questions about this trial

What is this clinical trial studying?

A study testing OTR4132MD in people with Stroke, Acute, run by Organ, Tissue, Regeneration, Repair and Replacement at 3 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 15 inclusion and 20 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 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

Rate of severe adverse events device related and dose limiting (time frame: 7 Days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04083001, which also lists 1 linked publication.

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 2 Aug 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in