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

NCT07323368 | Recruiting DMC

• 1 other identifier: SQ2024QB01857
• Study Type: interventional
• Target: 568
• Locations: 1 country
• Sites: 6

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.

Conditions

Stroke Ischemic; Medium Vessel Occlusions

Keywords

ischemic stroke; medium vessel occlusions; endovascular treatment; perfusion imaging

Outcome Measures

Primary Outcomes (1)

• The proportion of patients who have a score of 0 or 1 on the modified Rankin Scale (mRS) at 90 days

  The proportion of patients with an mRS score ≤ 1 at 90 days. The mRS score is a seven-point ordered categorical scale from 0 to 6 for functional neurological outcome, with 0 indicating no neurological symptoms and 6 indicating death.

  90 days

Secondary Outcomes (10)

• Ordinal distribution of modified Rankin Scale (mRS) at 90 days

  90 days

• The proportion of patients with an modified Rankin Scale (mRS) score of 0-2 at 90 days

  90 days

• The rate of early neurological improvement at 24 hours

  24 hours

• The proportion of patients with an modified Rankin Scale (mRS) score of 5-6 at 90 days

  90 days

• The median value of EuroQol 5-Dimension (EQ-5D) index

  90 days and 1 year

Other Outcomes (3)

• The proportion of successful recanalization

  immediately after the intervention

• The proportion of improvement on reperfusion at 24 hours after randomization

  24 hours

• The proportion of complete recanalization at 24 hours after randomization

  24 hours

Study Arms (2)

Endovascular treatment (EVT) +Best medical treatment

EXPERIMENTAL

The treating physician should attempt to perform EVT with the goal to restore blood flow to the affected vascular territory immediately after randomisation. 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. All decisions regarding the performance of EVT are made by the treating physician, based on his/her own judgement, and using local standards for endovascular treatment technique and devices and/or medications used for EVT. All other treatments (especially after-care and best medical treatment) will not differ between the intervention and control group.

Procedure: Endovascular treatment

Best medical treatment (BMT)

OTHER

Administration of BMT should be done according to routine clinical practice and current guidelines.

Drug: Best medical treatment (BMT)

Interventions

Endovascular treatment PROCEDURE

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.

Endovascular treatment (EVT) +Best medical treatment

Best medical treatment (BMT) DRUG

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.

Best medical treatment (BMT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (6)

Beijing tiantan hospital

Beijing, Beijing Municipality, 100070, 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

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yunyun Xiong, professor

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yunyun Xiong, professor

CONTACT

86-10-59978350; xiongyunyun@bjtth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: January 7, 2026
• Study Start: February 8, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2028
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

CN (6)