Large Stroke Therapy Evaluation

NCT03811769 | Terminated

• 1 other identifier: RECHMPL18_0173
• Study Type: interventional
• Target: 335
• 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. The overall burden of stroke will rise dramatically in the next 20 years due to an ageing population. 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. Acute ischemic stroke (AIS) due to large vessel occlusion (LVO) is a potentially devastating event, with a poor prognosis in the absence of timely revascularization. Whether in patients with large anterior circulation stroke, direct mechanical intervention is equally effective, superior or inferior to bridging thrombolysis remains a matter of debate. Thus, this procedure, is now the recommended standard of care for selective patients with LVO in the anterior circulation. When performed with newer generation devices (mainly stent retrievers), more stringent imaging selection criteria and more efficient workflow than in previous trials, significantly reduces disability rates after AIS caused by LVO in the anterior circulation. The STAIR (Stroke Treatment Academic Industry Roundtable) meeting aims to advance acute stroke therapy development through collaboration between academia, industry, and regulatory institutions. In pursuit of this goal and building on the available level I evidence of benefit from endovascular therapy (EVT) in large vessel occlusion stroke, STAIR IX 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)

• Evaluation of patient's condition

  Shift on the mRS at 90 days in experimental group vs the control group

  3 months

Secondary Outcomes (8)

• Evaluation of patient's condition

  6 months

• Evaluation of good functional outcome

  3 and 6 months

• Evaluation of functional outcome

  3 and 6 months

• Evaluation of treatment effect

  3 and 6 months

• Evaluation of quality of life

  3 and 6 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 medical treatment

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.

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 BMT arm start of treatment is defined as the date and time of groin puncture (arterial access).

Mechanical Thrombectomy (MT)

Eligibility Criteria

• Age: 18 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 symptoms onset or TLKW ≤ 6.5 hours from randomization, or with negative FLAIR on MRI if TLSW is unknown, with treatment started within 7 hours.
• Proven Large Ischemic Core defined as: ASPECT Score ≤ 5 on non-contrast CT or DWI-MRI, and in patients ≥ 80 years: ASPECT = 3 to 5 on non-contrast CT or DWI-MRI
• Proved anterior circulation intracranial large vessel occlusion on CTA or MRA (intracranial ICA, M1, M1-M2). The MCA - M1 segment is defined as the first branch of the intracranial ICA which courses horizontally from its branching point off the ICA through the Sylvian fissure up to the first bifurcation distal to the lenticulo-striate arteries, in the Sylvian fissure. M2 is defined as the portions of the MCA distal to the first bifurcation or trifurcation, but prior to the second bifurcation.
• Patient or patient's representative has received information about the study and has signed and dated the appropriate Informed Consent Form
• Selection imaging performed ≤ 3 hours before randomization
• Anticipated possibility to start the procedure (arterial access) within 30 minutes after randomization
• Pre stroke mRS ≤ 1
• Subjects receiving antiaggregant and/or anticoagulant agents (at any mode of administration) within the last 24 hours from screening are eligible for participation.
• NIHSS \> 6
• For patients for whom thrombolytic therapy, such as IV t-PA, is indicated, such treatment is initiated as soon as possible and within the accepted clinical guidelines as measured from stroke symptom onset.

You may not qualify if:

• 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 interfere with the 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.
• Blood glucose \< 50 mg/dL or \> 400 mg/dL
• Cr \> 4.0 mg/dL, unless the patient is on dialysis
• Platelet count \< 50000/uL
• INR \> 3.0 or PTT \> 3 times upper limit of normal (ULN)

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Hopital Gui De Chauliac

Montpellier, 34295, France

Location

Related Publications (3)

• Costalat V, Jovin TG, Albucher JF, Cognard C, Henon H, Nouri N, Gory B, Richard S, Marnat G, Sibon I, Di Maria F, Annan M, Boulouis G, Cardona P, Obadia M, Piotin M, Bourcier R, Guillon B, Godard S, Pasco-Papon A, Eker OF, Cho TH, Turc G, Naggara O, Velasco S, Lamy M, Clarencon F, Alamowitch S, Renu A, Suissa L, Brunel H, Gentric JC, Timsit S, Lamy C, Chivot C, Macian-Montoro F, Mounayer C, Ozkul-Wermester O, Papagiannaki C, Wolff V, Pop R, Ferrier A, Chabert E, Ricolfi F, Bejot Y, Lopez-Cancio E, Vega P, Spelle L, Denier C, Millan M, Arenillas JF, Mazighi M, Houdart E, Del Mar Freijo M, Duhamel A, Sanossian N, Liebeskind DS, Labreuche J, Lapergue B, Arquizan C; LASTE Trial Investigators. Trial of Thrombectomy for Stroke with a Large Infarct of Unrestricted Size. N Engl J Med. 2024 May 9;390(18):1677-1689. doi: 10.1056/NEJMoa2314063.

  PMID: 38718358 BACKGROUND

• Cody JT. Cross-reactivity of amphetamine analogues with Roche Abuscreen radioimmunoassay reagents. J Anal Toxicol. 1990 Jan-Feb;14(1):50-3. doi: 10.1093/jat/14.1.50.

  PMID: 2314063 BACKGROUND

• Costalat V, Lapergue B, Albucher JF, Labreuche J, Henon H, Gory B, Sibon I, Boulouis G, Cognard C, Nouri N, Richard S, Marnat G, Di Maria F, Annan M, Duhamel A, Cagnazzo F, Jovin T, Arquizan C; LASTE Trial Investigators. Evaluation of acute mechanical revascularization in large stroke (ASPECTS ⩽5) and large vessel occlusion within 7 h of last-seen-well: The LASTE multicenter, randomized, clinical trial protocol. Int J Stroke. 2024 Jan;19(1):114-119. doi: 10.1177/17474930231191033. Epub 2023 Jul 31.

  PMID: 37462028 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

  Hôpital Foch

  PRINCIPAL INVESTIGATOR

• Tudor JOVIN, PU-PH

  Cooper Neurological Institute

  PRINCIPAL INVESTIGATOR

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 10, 2019
• First Posted: January 22, 2019
• Study Start: April 7, 2019
• Primary Completion: April 26, 2023
• Study Completion: August 24, 2023
• Last Updated: September 29, 2025

Record last verified: 2025-09

Locations

FR (1)