DISTAL Trial: EVT for Medium/Distal Vessel Occlusion Stroke
In patients with medium or distal vessel occlusion (M2, M3, M4, ACA, or PCA), does endovascular thrombectomy plus best medical treatment improve 90-day functional outcome compared with best medical treatment alone?
Psychogios M, Brehm A, et al. N Engl J Med. 2025;392(14):1374-1384 · 543 patients
Population
Included
- Medium or distal vessel occlusion (M2, M3, M4, ACA, or PCA segment)
- Age 18 or older
- NIHSS 4 or higher
- Pre-morbid mRS 2 or lower
- Last known well within 24 hours
- Acute ischemic stroke
- Isolated medium vessel occlusion: nondominant or codominant M2, or M3/M4 segment of the MCA; A1, A2, or A3 segment of the ACA; or P1, P2, or P3 segment of the PCA
- NIHSS score ≥4 points, OR symptoms deemed clearly disabling at lower NIHSS
- Treatment (arterial puncture) initiable within 6 hours of last-seen-well, OR within 6–24 hours of last-seen-well with neuroimaging evidence of salvageable tissue (perfusion–diffusion mismatch on CT or MRI)
- Agreement of treating physician to perform the endovascular procedure
- Informed consent by signature, or fulfilling criteria for emergency/deferred consent
Excluded
- Large vessel occlusion (ICA, M1, or basilar artery)
- ASPECTS below 4 on CT or DWI-ASPECTS below 4 on MRI
- Severe comorbidity
- Acute intracranial haemorrhage
- Evidence of vessel recanalization prior to randomisation
- Patient bedridden or presenting from a nursing home
- In-hospital stroke
- Severe comorbidities likely to prevent improvement or follow-up
- Known serious sensitivity to radiographic contrast agents, nickel, titanium metals or their alloys
- Contraindication to arterial access
- Intracranial mass or tumor (excluding small meningioma)
- Radiologically confirmed cerebral vasculitis
- Pregnancy or lactating women
- Geographic factors precluding follow-up
- Participation in another interventional trial
Source: ClinicalTrials.gov NCT05029414 (DISTAL)· Retrieved 2026-06-08
Primary Outcome — mRS Distribution at 90 Days
All randomized patients (medium/distal vessel occlusion)
Study Arms
- Agent
- Endovascular thrombectomy (operator-chosen technique) + best medical treatment
- Route
- Endovascular (intra-arterial)
- Co-interventions
- EVT technique at operator discretion; any commercially available device (combined first-line 64.6%, stent-retriever only 15.7%, aspiration only 15.7%). Best medical treatment per current local/European guidelines. IV thrombolysis given in 62.0% of this arm when eligible. Stroke-unit/ICU admission.
EVT performed in 229/271 (84.5%); final mTICI ≥2b 71.7%; median imaging-to-puncture 70 min (Psychogios NEJM 2025 p.1377,1379).
- Agent
- Best medical treatment alone (no endovascular thrombectomy)
- Route
- Systemic / supportive
- Co-interventions
- Best medical treatment per current local/European guidelines, including IV thrombolysis where eligible (given in 68.8% of this arm). Stroke-unit/ICU admission.
2/272 (0.7%) crossed over to EVT (Psychogios NEJM 2025 Fig.1 p.1377).
Trial Design
Type
- International, multicenter, assessor-blinded RCT
- 1:1 randomization: EVT + BMT vs BMT alone
- Pragmatic design - any EVT technique allowed
- Treated within 24 hours of last seen well
Timeline
Dec 2021 – Jul 2024, 55 sites, 11 countries (mostly Europe)
N
543
Enrollment
Randomized December 2021 to July 2024 at 55 sites across 11 countries (predominantly Europe). International, assessor-blinded RCT. Any EVT technique allowed; treated within 24 hours of last known well.
ClinicalTrials.gov
NCT05029414Bedside Pearl
DISTAL and ESCAPE-MeVO together provide strong evidence against routine EVT for unselected medium or distal vessel occlusions. The 71.7% reperfusion rate, well below the 85-90% seen in large-vessel trials, reflects the technical challenge of accessing M3-M4 and ACA/PCA segments. Symptomatic ICH was more than doubled with EVT (5.9% vs 2.6%) without mortality benefit. Current evidence does not support routine EVT for MeVO outside of highly selected cases or ongoing trials.
See also
Trial lineage
Endovascular therapy for medium-vessel and distal occlusions
ESCAPE-MeVO and DISTAL, both published in 2024, were the first RCTs in medium-vessel and distal occlusions (M2/M3, ACA, PCA). Neither met its primary functional endpoint. Together they define the negative boundary of LVO-EVT — the closer a patient is to a non-large-vessel target, the less benefit EVT confers. Practice has shifted toward selective EVT for MeVOs only with severe deficit and accessible anatomy.
- 2025DISTAL Trial· this pageNEGATIVE
EVT for medium and distal vessel occlusions; negative trial (NEJM 2025).
- 2025ESCAPE-MeVO TrialNEGATIVE
EVT for medium vessel occlusion (MeVO); no functional benefit, higher sICH and mortality (NEJM 2025).