Trial and Cost Effectiveness Evaluation of Intra-arterial Thrombectomy in Acute Ischemic Stroke

Conditions

Cerebral Stroke, Cerebrovascular Accident

Keywords

mechanical Thrombectomy, CVA (Cerebrovascular Accident), Cerebrovascular Accident, Acute

Brief summary

THRACE is a controled, multicenter and randomized trial. The primary objective of this study is to determine whether a combined approach intravenous thrombolysis (IV) + Mechanical thrombectomy is superior to the reference treatment with IV thrombolysis alone, in the 3 hours of onset of symptoms in patients with occlusion of proximal cerebral arteries and with a neurological impairment accident (National Institutes of Health Stroke Scale \[NIHSS\] ≥ 10). The second objective is to determine the cost-effectiveness of this procedure compared to the standard (IV thrombolysis). The assumption is that the combined approach, by improving the clinical outcome and speed recovery, allows for lower overall costs to the IV thrombolysis in 3 months and less than or at worst neutral to 1 year.

Agbonon R, Forestier G, Bricout N, Benhassen W, Turc G, Bretzner M, Pasi M, Benzakoun J, Seners P, Derraz I, Legrand L, Trystram D, Rodriguez-Regent C, Charidimou A, Rost NS, Bracard S, Cordonnier C, Eker OF, Oppenheim C, Naggara O, Henon H, Boulouis G.

2024-02-147 citations

10.1007/s00415-024-12205-7

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10.1212/wnl.0000000000008317

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Corentin Provost, Marc Soudant, Laurence Legrand, Wagih Ben Hassen, Yu Xie et al. (15 authors)

Stroke2019-02-12134 citations

10.1161/strokeaha.118.023882

Cost-Effectiveness of Thrombectomy in Patients With Acute Ischemic Stroke

Hamza Achit, Marc Soudant, Kossar Hosseini, Aurélie Bannay, Jonathan Epstein et al. (7 authors)

Stroke2017-09-1561 citations

10.1161/strokeaha.117.017856

Mechanical thrombectomy after intravenous alteplase versus alteplase alone after stroke (THRACE): a randomised controlled trial.

Bracard S, Ducrocq X, Mas JL, Soudant M, Oppenheim C, Moulin T, Guillemin F, THRACE investigators.

2016-08-23878 citations

10.1016/s1474-4422(16)30177-6

Interventions

DRUGAlteplase (rt-PA)/Actilyse

Injection of 0.9 mg/kg for 60min with an initial 10% bolus injection.

PROCEDUREMechanic thrombectomy (MERCI, PENUMBRA, CATCH, SOLITAIRE)

Mechanic thrombectomy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

No

Inclusion criteria

* 10\<=NIHSS Score=\<25 * Symptoms onset less than 4 hours * Occlusion of the intracranial carotid, the middle cerebral artery (M1) or the upper third of the basilar

Exclusion criteria

* Contraindications for intravenous thrombolysis * Occlusion or stenosis of the pre-occlusive cervical internal carotid artery ipsilateral to the lesion * Any cause local prohibiting femoral catheterization

Design outcomes

Primary

Measure	Time frame
Modified Rankin Score (mRs )	3 months after treatment

Secondary

Measure	Time frame
Quality of Life (Euroqol EQ-5D)	3 months after treatment
Barthel Score	3 months after treatment

Countries

France

Outcome results

None listed