NCT07906275Not yet recruitingPhase 3
INTRA-ARTERIAL MeVO TREATMENT (IMP-ACT) Within the ACT-GLOBAL Adaptive Platform Trial-NCT06352632
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
Source: ClinicalTrials.gov · Last updated 30 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 800 (estimated)
- First submitted
- 19 Oct 2026
- Start date
- 15 Dec 2026
- Primary completion date
- 31 Dec 2030
- Lead sponsor
- University of Calgary
- Diseases
- Stroke
- NCT number
- NCT07906275
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 800
- From 15 Dec 2026 to the primary completion date, 31 Dec 2030
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Calgary- Foothills Medical Centre Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| University of Alberta Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| University of British Columbia Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| University of Manitoba - Winnipeg Health Science Centre Coordinator of this site? Confirm its status | Winnipeg | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.