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

NCT04083001 | Completed DMC

• 1 other identifier: 2018-A03117-48
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Stroke, Acute

Keywords

Stroke; FIM; OTR3

Outcome Measures

Primary Outcomes (1)

• Rate of severe adverse events device related and dose limiting

  Severe adverse events

  7 Days

Secondary Outcomes (8)

• Survival rates

  24 hours, 7 Days, 30 Days, 90 Days

• All cause death

  24 hours, 7 Days, 30 Days, 90 Days

• Stroke related death

  24 hours, 7 Days, 30 Days, 90 Days

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

  24 hours, 7 Days, 30 Days, 90 Days

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

  24 hours, 7 Days, 30 Days, 90 Days

Other Outcomes (1)

• Revascularization on 24-hour follow-up imaging

  24 Hours

Study Arms (1)

OTR4132MD

EXPERIMENTAL

One 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.

Device: OTR4132MD

Interventions

OTR4132MD DEVICE

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.

OTR4132MD

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \*.
• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Organ, Tissue, Regeneration, Repair and Replacement: lead
• European Commission: collaborator
• Euraxi Pharma: collaborator

Study Sites (3)

CHU Grenoble Alpes

Grenoble, Auvergne-Rhône-Alpes, 38000, France

Location

CHU Nancy

Nancy, Grand Est, 54000, France

Location

CHU Bordeaux Pellegrin

Bordeaux, Nouvelle-Aquitaine, 33000, France

Location

Related Publications (1)

• 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.

  PMID: 41037228 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Olivier Detante

  CHU Grenoble Alpes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: open study

Study Record Dates

• First Submitted: September 3, 2019
• First Posted: September 10, 2019
• Study Start: March 3, 2022
• Primary Completion: June 19, 2024
• Study Completion: June 19, 2024
• Last Updated: August 2, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)