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NOT YET RECRUITING

NCT07906275

PHASE3

INTRA-ARTERIAL MeVO TREATMENT (IMP-ACT) Within the ACT-GLOBAL Adaptive Platform Trial-NCT06352632

Sponsor: University of Calgary

View on ClinicalTrials.gov

Summary

This domain will be conducted as part of ACT-GLOBAL platform trial and will have the nested domain name of IMP-ACT. Acute ischemic stroke (AIS) caused by intracranial arterial occlusion remains a major cause of disability and death. Medium vessel occlusion stroke (MeVO), involving distal medium-sized intracranial arteries, accounts for approximately 25-40% of all AIS cases. Despite best medical management, including intravenous thrombolysis, up to 40% of MeVO patients fail to regain functional independence, and mortality remains approximately 10%. These poor outcomes prompted several randomized trials evaluating endovascular thrombectomy (EVT) for MeVO stroke, including the CIHR-funded ESCAPE-MeVO trial. ESCAPE-MeVO, DISTAL, and DISCOUNT did not demonstrate overall benefit of EVT compared with best medical management, whereas ORIENTAL-MeVO reported benefit in an Asian population. These conflicting findings have resulted in uncertainty regarding optimal MeVO management and suggest that treatment benefit may depend on patient selection. A potential explanation for the neutral EVT trials is suboptimal reperfusion. In ESCAPE-MeVO, successful reperfusion was achieved in only 75% of patients, leaving substantial room for procedural improvement. At the same time, major procedural complications were infrequent, supporting the feasibility of exploring strategies to enhance reperfusion. Subgroup analyses from ESCAPE-MeVO suggested that treatment effect may vary according to time from symptom onset and collateral status. Patients treated early after stroke onset and those with favorable collaterals appeared to derive greater benefit from EVT than later presenters or patients with poor collateral circulation. These findings support a more targeted treatment approach in selected MeVO patients. Intra-arterial thrombolysis (IAT) has emerged as a promising adjunct to EVT. Local delivery of thrombolytic agents may dissolve residual distal thrombi that are inaccessible or unsafe to treat mechanically and may improve both macrovascular and microvascular reperfusion. Because thrombus burden is generally smaller in MeVO stroke, adjunctive IAT may be particularly effective in this population. However, no randomized trial has evaluated combined EVT and IAT for primary MeVO stroke. This study will address that evidence gap and determine whether adjunctive IAT can improve outcomes in carefully selected patients with MeVO stroke.

Official title: Intra-Arterial Treatment of Medium-sized Primary Vessel Occlusions: A Randomized Controlled Trial (IMP-ACT)Embedded in A Multi-faCtorial,mulTi-arm, Multi-staGe,Randomised,gLOBal Adaptive pLatform Trial for Stroke NCT06352632

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

800

Start Date

2026-12-15

Completion Date

2031-03-31

Last Updated

2026-10-30

Healthy Volunteers

Conditions

Stroke, Acute Ischemic Medium Vessel Occlusion

Interventions

PROCEDURE

Mechanical Endovascular Thrombectomy

Mechanical endovascular thrombectomy (EVT) is a minimally invasive endovascular procedure used to remove a blood clot from an intracranial artery causing acute ischemic stroke. A catheter is advanced through the arterial system to the site of occlusion, where specialized devices such as stent retrievers and aspiration catheters are used to restore blood flow by removing the clot. EVT is an established treatment for selected patients with acute ischemic stroke and is intended to improve neurological recovery by achieving rapid reperfusion of threatened brain tissue.

DRUG

Intravenous Thrombolysis

Tenecteplase IV may be administered, if eligible, as part of the Control Arm.

BIOLOGICAL

Tenecteplase/Alteplase- depending upon availability at each treating centre

The intervention group will receive local intra-arterial (IA) thrombolysis using either tenecteplase at a dose of 0.0625mg/kg "maximum dose of 6.25mg" or alteplase "0.225 mg/kg; maximum dose, 20mg.

Inclusion Criteria: Platform inclusion criteria: * Age ≥18 years. * Clinical diagnosis of stroke. Domain (IMP-ACT) inclusion criteria: * All patients with acute ischemic stroke caused by a medium vessel occlusion who are clinically eligible for immediate EVT and IAT. Patients with conditions described as relative contraindications for thrombolysis in national guidelines, where physician discretion is recommended, are eligible. Patients who received a direct-acting oral anticoagulant (DOAC) are eligible. * Time from onset (or last seen well) to randomization ≤4.5 hours. * Baseline National Institutes of Health Stroke Scale (NIHSS) score \>5 at the time of randomization. * Confirmed symptomatic and endovascularly treatable MeVO based on non-invasive neurovascular imaging (CTA or MRA) at one or more of the following locations: M2 or M3 segment, A2 or A3 segment, P2 or P3 segment. * Good or moderate collateral status on CT angiography or MRA. * Clinical deficit commensurate with the MeVO occlusion location. * Consent process completed as per national laws and regulations and the applicable ethics committee requirements. Exclusion Criteria: * There are no platform-level exclusion criteria. Domain (IMP-ACT) exclusion criteria: * ASPECTS \<9. * Well-demarcated hypodensity in the majority of the brain parenchyma supplied by the occluded vessel. * Poor or no collateral status on CTA. * Any evidence of intracranial hemorrhage on qualifying imaging. * Patient has a major co-morbid illness, such that they are unlikely to complete follow-up or achieve the primary outcome due to the underlying illness * Any absolute contraindication for thrombolysis per current national guidelines - for example active bleeding, recent (\<7 days) intracranial surgery, head trauma, acute intracranial or subarachnoid hemorrhage, or a bleeding diathesis. Adaptive enrichment: Adaptive enrichment rules will allow restriction of enrolment to patients presenting ≤3 hours and/or with NIHSS \>7 if interim data suggest lack of benefit among those presenting later or with baseline NIHSS ≤7.

Locations (4)

University of Calgary- Foothills Medical Centre

Calgary, Alberta, Canada

University of Alberta

Edmonton, Alberta, Canada

University of British Columbia

Vancouver, British Columbia, Canada

University of Manitoba - Winnipeg Health Science Centre

Winnipeg, Manitoba, Canada