NCT07323368

Advancing Reperfusion Therapy for Ischemic Stroke: Perfusion-guided Endovascular Intervention for Medium Vessel Occlusion Therapy

Advancing Reperfusion Therapy for Ischemic Stroke (ARTS): Perfusion-guided Endovascular Intervention for Medium Vessel Occlusion Therapy (PIVOT)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 568 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators initiated a multicenter, prospective, randomized, open label, blinded-endpoint (PROBE) controlled trial to evaluate the efficacy and safety of perfusion-guided endovascular treatment (EVT) compared to standard medical care for patients with acute ischemic stroke due to medium vessel occlusion (MeVO) within 24 hours from symptom onset.

Detailed description

Adult acute ischemic stroke patients due to primary medium vessel occlusions (non-dominant proximal M2 or mid-distal M2/M3 segments of the middle cerebral artery, A1/A2/A3 segments of the anterior cerebral artery, and P1/P2/P3 segments of the posterior cerebral artery) confirmed by CTA/MRA and responsible for the signs and symptoms of acute ischemic stroke with baseline National Institutes of Health Stroke Scale (NIHSS) ≥8 will be enrolled in this trial. The investigators use perfusion imaging to select subjects and the enrolled patients have target mismatch profile on CTP or MRI+PWI (ischemic core volume \<70mL, mismatch ratio\>1.2, mismatch volume \>10mL). The eligible patients will be randomly assigned to receive endovascular treatment (EVT) +best medical treatment or best medical treatment within 24 hours after the time that the patient was last known to be well (including after stroke on awakening and unwitnessed stroke). The primary outcome is the proportion of patients with an mRS score ≤ 1 at 90 days.

Conditions

• Stroke Ischemic
• Medium Vessel Occlusions

Interventions

Type	Name	Description
PROCEDURE	Endovascular treatment	EVT included thrombectomy with stent retrievers, thromboaspiration, intraarterial thrombolysis, balloon angioplasty, stenting, or a combination of these approaches at the discretion of the interventional team.
DRUG	Best medical treatment (BMT)	Administration of BMT should be done according to routine clinical practice and current international guidelines. Administration of BMT must not be delayed by randomisation and should be done independently from participation in this trial.

Timeline

• Start date: 2026-02-08
• Primary completion: 2027-09-30
• Completion: 2028-09-30
• First posted: 2026-01-07
• Last updated: 2026-02-10

Locations

6 sites across 1 country: China