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FRONTIER-AP-X: Randomized controlled trial of endovascular versus standard medical therapy for stroke with medium sized vessel occlusion

FRONTIER-AP-X: Randomized controlled trial of endovascular versus standard medical therapy or patients presenting with acute ischaemic stroke with medium sized vessel occlusion

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000590460
Acronym
FRONTIER-APX
Enrollment
240
Registered
2025-06-06
Start date
2025-07-01
Completion date
2027-06-28
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

FRONTIER-APX is an Australian led trial in the Asia-Pacific region (FRONTIER-AP) which seeks to answer an important clinical conundrum on the optimal treatment approach for patients with clot in medium sized vessels (MVO) in the brain. Following the results of multiple randomized clinical trials some states in Australia have structured clinical pathways for treatment of patients with large vessel occlusion (LVO). Such knowledge does not exist for MVO. In 2025, several trials on medium vessel occlusion reported no superiority of thrombectomy over standard care. The DISTAL trial recruited patients with occlusion of the second to fourth order branch of the middle cerebra artery, first to third order branch of the anterior cerebral artery and posterior cerebral artery. Analyses of the data suggest that equipoise remains for patients with occlusion of the second to third order branch of the middle cerebral artery (M2-3) but not for the anterior or posterior cerebral arteries. These lessons have been adapted into the FRONTIER-APX trial and is reflected in the inclusion and exclusion criteria.

Interventions

Patients randomised to the thrombectomy arm will have clot extraction by Stent retriever or aspiration catheter. This will be performed by certified interventional radiologist. In brief, it involves performing digital subtraction angiography, navigating the catheter to the site of the clot and performing the extraction. The procedure is anticipated to be around 1 hour but can take up to 2 hours on average. The standard care arm is alteplase or tenecteplase within 4.5 hours and between 4.5 - 9 hours, it’s alteplase or tenecteplase or best medical therapy according to the local guidelines. Post-intervention: A non-contrast Computed Tomography (CT) and CT Angiography will be performed 24 to 48 hr post intervention. At the investigator’s discretion, a repeat CT Perfusion or Magnetic Resonance Imaging (MRI) may be performed at 24 to 48 hr. For MRI (if used for baseline selection and at 24 to 48hrs), an initial scout view will be followed by isotropic Difiusion-weighted Imaging/DWI (created from DWI images obtained with diffusion sensitizing gradients applied in 3 orthogonal planes) using b values between 0 sec/mm2, equivalent to a T2-weighted image, and 1000 sec/mm2. Whole brain imaging will use 25 contiguous axial slices each 5 mm in thickness. The imaging time for DWI is approximately 3 minutes. Time of Flight MR Angiography will be obtained to determine the presence or absence of medium vessel occlusion (MVO). A T2*-weighted gradient echo sequence will be performed to assess for presence of intracerebral haemorrhage (ICH). A FLAIR sequence is also acquired. This protocol is identical between the acute and sub-acute (24 h) imaging.

Sponsors

Melbourne Health
Lead SponsorGovernment body

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Patients presenting with acute ischaemic stroke within 24 hours of stroke onset. 2. National Institute of Health Stroke Scale (NIHSS) greater or equal 8 and penumbra mismatch volume greater or equal 10 mL and penumbra ratio greater or equal to 1.2 3. Patient’s age is greater or equal to 18 years (or as per local requirements) 4. Endovascular therapy (arterial puncture) within 90 minutes of initial CT brain. 5. Arterial occlusion on CT Angiography (CTA) or MR Angiography (MRA) of the MeVO affecting M2/M3

Exclusion criteria

1. Patients presenting with acute ischaemic stroke >24 hours of stroke onset16. 2. Intracranial haemorrhage identified by CT or MRI 16. 3. Anterior Cerebral Artery (ACA) or Posterior Cerebral Artery (PCA) occlusion 4. Rapidly improving symptoms at the discretion of the investigator 5. Pre-stroke modified Rankin Score (mRS) score of >2 (indicating previous disability) 6. Hypodensity in >1/3 MCA territory on non-contrast CT. 7. ICA (large vessel) occlusion ipsilateral to the distal MCA or ACA clot 8. Contraindication to imaging with contrast agents (requirement for performing thrombectomy) 9. Any terminal illness such that the patient has life expectance less than 1 year. 10. Patients with active cancer and undergoing treatment for cancer are excluded. 11. Any condition that, in the judgment of the investigator, could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study. 12. Pregnancy

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026