Minor Stroke Therapy Evaluation

NCT03796468 | Unknown

• 1 other identifier: RECHMPL18_0172
• Study Type: interventional
• Target: 824
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke represents the fourth leading cause of death in industrialized nations, after heart disease, cancer, and chronic lower respiratory disease. Approximately one-quarter of the patients suffering a stroke die within one year after the initial event and stroke is a leading cause of serious long-term disability. Although mechanical thrombectomy (MT) has become the standard of care for acute ischemic stroke with proximal large vessel occlusion (LVO) in the anterior circulation, the management of patients harboring proximal occlusion but presenting minor-to-mild stroke symptoms, has not yet been determined by these recent randomized clinical trials. However, patients with proximal occlusions may present with a low NIHSS, a proximal intraarterial occlusion being present in up to 28% when considering patients with an NIHSS ≤ 4. The evidence of benefit from endovascular therapy (EVT) in large vessel occlusion stroke is demonstrated, STAIR IX (Stroke Treatment Academic Industry Roundtable) consensus recommendations were developed that outline priorities for future research in EVT.

Conditions

Stroke

Keywords

Mechanical thrombectomy; stroke; Proximal intracranial arterial occlusions; Large vessel occlusion

Outcome Measures

Primary Outcomes (1)

• Incidence of all-cause mortality at 90 days

  Evaluation of mortality at 90 days

  3 months

Secondary Outcomes (9)

• Incidence of symptomatic intracerebral hemorrhage

  1 day

• Deterioration of patient's condition

  3 months

• Incidence of procedure/device-related adverse events

  1 day

• Evaluation of functional outcome

  3 months

• Quality of life of the patient

  3 months

Study Arms (2)

Best Medical Therapy (BMT)

OTHER

Best treatment medical probably associated to the rescue endovascular treatment in case of neurological deterioration

Other: Best Medical Therapy

Mechanical Thrombectomy (MT)

OTHER

Endovascular treatment (thrombectomy) associated with the best treatment medical

Procedure: Mechanical Thrombectomy

Interventions

Best Medical Therapy OTHER

The administration of medications is at the treating physician's discretion (for example intravenous fibrinolysis, anticoagulants or antiplatelet) according to local standards of care but may NOT include any intra-arterial therapies. The rescue MT may be performed in case of deterioration within the 24 hours

Best Medical Therapy (BMT)

Mechanical Thrombectomy PROCEDURE

MT in the Experimental Arm can be performed with any thrombectomy (CE labeled) device usually used at study site. For the subjects randomized to the MT plus medical, the MT is performed immediately after the randomization

Mechanical Thrombectomy (MT)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical signs consistent with acute ischemic stroke with time last known well (TLKW) ≤ 23h at randomization (With the goal of remaining within 24 hours from TLKW til treatment)
• Patients NIHSS 0-5 at the time of randomization
• ASPECT ≥ 6 on non-contrast CT or Diffusion Weighted Imaging (DWI)-MRI
• Ischemic Stroke confirmed with cerebral imaging or normal imaging with suspected ischemic stroke
• Proved anterior circulation intracranial large vessel occlusion on CTA or Magnetic resonance angiography (MRA) (ICA, M1, M1-M2, with or without cervical lesion (Tandem))
• Patient or patient's representative has received information about the study and has signed and dated the appropriate Informed Consent Form, or fulfilling the criteria for emergent consent.
• Anticipated possibility to start the procedure (arterial access) within 60 minutes after randomization
• Pre stroke mRS ≤ 1

You may not qualify if:

• Anticipated impossibility to start the procedure (arterial access) within 60 minutes after randomization
• Known absence of vascular access
• Known contrast or endovascular product life-threatening allergy
• Female who is known to be pregnant or lactating at time of admission
• Patient presents severe or fatal co-morbidities or Life expectancy under 6 months that will likely prevent improvement or follow-up or that will render the procedure unlikely to benefit the patient.
• Patient unable to present or be available for follow-up
• Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations
• Evidence of vessel recanalization prior to randomization
• Seizures at stroke onset if it makes the diagnosis of stroke doubtful and precludes obtaining an accurate baseline NIHSS assessment.
• Current participation in another investigational drug study
• Suspicion of aortic dissection based on medical history, clinical evaluation or/and imaging
• Major patients under guardianship
• Evidence of intracranial hemorrhage on CT/MRI
• Excessive tortuosity of cervical vessels on CTA/MRA that would likely result in unstable access platform
• High Suspicion of underlying intracranial stenosis on CTA/MRA

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Hopital Gui De Chauliac

Montpellier, 34295, France

RECRUITING

Related Publications (2)

• Seners P, Cereda CW. Thrombectomy in Stroke With a Large Vessel Occlusion and Mild Symptoms: "Striving to Better, Oft We Mar What's Well?". Stroke. 2023 Sep;54(9):2276-2278. doi: 10.1161/STROKEAHA.123.044205. Epub 2023 Aug 1. No abstract available.

  PMID: 37526012 DERIVED

• Arquizan C, Lapergue B, Gory B, Labreuche J, Henon H, Albucher JF, Sibon I, Turc G, Richard S, Nouri N, Cognard C, Marnat G, Naggara O, Di Maria F, Duhamel A, Jovin T, Costalat V; MOSTE Trial Investigators. Evaluation of acute mechanical revascularization in minor stroke (NIHSS score ⩽ 5) and large vessel occlusion: The MOSTE multicenter, randomized, clinical trial protocol. Int J Stroke. 2023 Dec;18(10):1255-1259. doi: 10.1177/17474930231186039. Epub 2023 Jul 16.

  PMID: 37350574 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

• Vincent COSTALAT, PU-PH

  Hôpital Gui de Chauliac

  PRINCIPAL INVESTIGATOR

• Caroline ARQUIZAN, PH

  Hôpital Gui de Chauliac

  PRINCIPAL INVESTIGATOR

• Bertrand LAPERGUE, PH

  Hôpital Foch

  PRINCIPAL INVESTIGATOR

• Tudor JOVIN, PU-PH

  Cooper Neurological Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline ARQUIZAN, PH

CONTACT

4 67 33 75 32; c-arquizan@chu-montpellier.fr

Bertrand LAPERGUE, PH

CONTACT

1 46255973; bertrand.lapergue@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2019
• First Posted: January 8, 2019
• Study Start: April 10, 2019
• Primary Completion: July 1, 2025
• Study Completion: October 1, 2025
• Last Updated: August 31, 2023

Record last verified: 2023-08

Locations

FR (1)