Perfusion-guided endovascular treatment for medium-vessel ischemic stroke

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

This trial will test whether using perfusion imaging to guide endovascular treatment helps adults with medium-vessel ischemic stroke (within 24 hours of last-known-well) recover better than standard medical care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 568 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beijing Tiantan Hospital (Academic / other)
• Locations: 6 sites (Beijing, Beijing Municipality and 5 other locations)
• Trial ID: NCT07323368 on ClinicalTrials.gov

What this trial studies

This is a multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) trial comparing endovascular treatment plus best medical care versus best medical care alone for acute ischemic stroke caused by medium-vessel occlusions. Eligible adults have confirmed MeVO on CTA/MRA, NIHSS ≥8, pre-stroke mRS ≤1, and a perfusion target mismatch on CTP or MR perfusion (ischemic core <70 mL, mismatch ratio >1.2, mismatch volume >10 mL). Patients are randomized within 24 hours of last-known-well and outcomes are measured with a blinded assessment of functional independence (mRS ≤1) at 90 days. The trial aims to determine if perfusion-guided selection can identify MeVO patients who benefit from endovascular therapy beyond standard care.

Who should consider this trial

Good fit: Adults aged 18 or older with acute ischemic stroke due to a primary medium-vessel occlusion, baseline NIHSS ≥8, pre-stroke mRS ≤1, and a perfusion target mismatch on CTP or MR perfusion within 24 hours of last-known-well are eligible.

Not a fit: Patients with intracranial hemorrhage, a large ischemic core (≥70 mL), insufficient perfusion mismatch, significant pre-stroke disability, or who cannot present to a participating site within the 24-hour window are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, this approach could increase the number of MeVO patients who regain independence after stroke by identifying those most likely to benefit from endovascular treatment.

How similar studies have performed: Endovascular therapy is well established for large-vessel occlusions, but randomized evidence for perfusion-guided EVT specifically in medium-vessel occlusions is limited, with mostly smaller observational studies and pilot data suggesting potential benefit.

Eligibility criteria

Inclusion Criteria:

* Age≥18 years old;
* Acute ischemic stroke symptom onset within 24 hours; including wake-up stroke and unwitnessed stroke, onset time refers to "last-seen normal time";
* Primary medium vessel occlusions confirmed by CTA/MRA, including non-dominant proximal M2 or mid-distal M2/M3 segments of the middle cerebral artery (MCA), A1/A2/A3 segments of the anterior cerebral artery (ACA), and P1/P2/P3 segments of the posterior cerebral artery (PCA) and responsible for the signs and symptoms of acute ischemic stroke;
* Pre-stroke modified Rankin scale (mRS) score ≤1;
* Baseline National Institutes of Health Stroke Scale (NIHSS) ≥8;
* Neuroimaging criteria: Target mismatch profile on CT perfusion or MRI+MR perfusion (ischemic core volume \<70 mL, mismatch rate \>1.2, mismatch volume \>10 mL);
* Written informed consent from patients or their legally authorized representatives.

Exclusion Criteria:

* Any evidence of intracranial hemorrhage on qualifying imaging;
* Known (serious) sensitivity to radiographic contrast agents, nickel, titanium metals or their alloys and unable to complete CTP/PWI;
* Known history of arterial tortuosity, pre-existing stent, other arterial disease and/or known disease at the arterial access site that would prevent the device from reaching the target vessel and/or preclude safe recovery after EVT;
* Radiological confirmed evidence of mass effect or intracranial tumour (except small meningioma);
* Clinical diagnosis of cerebral vasculitis;
* Evidence of vessel recanalization prior to randomisation;
* Severe comorbidities, which will likely prevent improvement or follow-up;
* Any terminal illness such that the patient would not be expected to survive more than 1 year;
* Hypodensity in \>1/3 MCA territory on non-contrast CT or significant hypodensity outside the current perfusion lesion suggesting distal clot migration (secondary MeVO);
* Multiple arterial occlusion;
* Pregnant women, nursing mothers, or reluctance to use effective contraceptive measures during the period of the trial;
* Unlikely to adhere to the trial protocol or follow-up;
* Participation in other interventional clinical trials within the previous 3 months.

Where this trial is running

Beijing, Beijing Municipality and 5 other locations

• Beijing tiantan hospital — Beijing, Beijing Municipality, China (Recruiting)
• Beijing Daxing District People's Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Xingtang County People's Hospital — Longzhou, Hebei, China (Recruiting)
• Luoyang Yiluo Hospital — Luoyang, Henan, China (Recruiting)
• People's Hospital of Queshan — Panlong, Henan, China (Recruiting)
• Changle People's Hospital — Changle, Shandong, China (Recruiting)

Study contacts

• Principal investigator: Yunyun Xiong, professor — Beijing Tiantan Hospital
• Study coordinator: Yunyun Xiong, professor

Conditions Stroke Ischemic; Medium Vessel Occlusions; ischemic stroke; medium vessel occlusions; endovascular treatment; perfusion imaging