Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 7:47 PM
Study NCT ID:
NCT07323368
Status:
RECRUITING
Last Update Posted:
2026-02-10
First Post:
2025-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Advancing Reperfusion Therapy for Ischemic Stroke: Perfusion-guided Endovascular Intervention for Medium Vessel Occlusion Therapy
Sponsor:
Beijing Tiantan Hospital
Organization:
Study Overview
Official Title:
Advancing Reperfusion Therapy for Ischemic Stroke (ARTS): Perfusion-guided Endovascular Intervention for Medium Vessel Occlusion Therapy (PIVOT)
Status:
RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ARTS-PIVOT
Brief 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: