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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke Ischemic; Medium Vessel Occlusions
• Intervention / Treatment: Procedure: Endovascular treatment; Drug: Best medical treatment (BMT)

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 Type: Interventional
• Enrollment (Estimated): 568
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yunyun Xiong, professor; Phone Number: 86-10-59978350; Email: xiongyunyun@bjtth.org

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100070
      • Recruiting
      • Beijing Tiantan Hospital
      • Contact: Yunyun Xiong, professor; Phone Number: 86-10-59978350; Email: xiongyunyun@bjtth.org
    • Beijing, Beijing Municipality, China
      • Recruiting
      • Beijing Daxing District People'S Hospital
      • Contact: Chunmiao Duan; Phone Number: 010-60283006; Email: miao3252003@163.com
  • Hebei
    • Longzhou, Hebei, China
      • Recruiting
      • Xingtang County People's Hospital
      • Contact: Yanxin Wang; Phone Number: 0311-82981231; Email: bdaczfg@163.COM
  • Henan
    • Luoyang, Henan, China
      • Recruiting
      • Luoyang Yiluo Hospital
      • Contact: Yajun Yang; Phone Number: 0379-82888808; Email: sqyyj7119@163.com
    • Panlong, Henan, China
      • Recruiting
      • People's Hospital of Queshan
      • Contact: Jianxin Xu; Phone Number: 0396-7068021; Email: 249957242@qq.com
  • Shandong
    • Changle, Shandong, China
      • Recruiting
      • Changle People's Hospital
      • Contact: Ruiguang Liu; Phone Number: 0536-6222822; Email: lrgys@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Endovascular treatment (EVT) +Best medical treatment; 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; 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.
Other: Best medical treatment (BMT); Administration of BMT should be done according to routine clinical practice and current guidelines.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ordinal distribution of modified Rankin Scale (mRS) at 90 days	Ordinal distribution of mRS at 90 days (shift analysis). 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
The proportion of patients with an modified Rankin Scale (mRS) score of 0-2 at 90 days	The proportion of patients with an mRS score of 0-2 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
The rate of early neurological improvement at 24 hours	The rate of early neurological improvement at 24 hours after randomization (defined as a National Institute of Health Stroke Scale [NIHSS] score ≤1 or ≥4 points compared with the baseline)	24 hours
The proportion of patients with an modified Rankin Scale (mRS) score of 5-6 at 90 days	The proportion of patients with an mRS score of 0-2 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
The median value of EuroQol 5-Dimension (EQ-5D) index	EuroQol 5-Dimension (EQ-5D) index at 90 days and 1 year. The EuroQol Group 5-Dimension Self-Report Questionnaire (EQ-5D) is a standardized instrument for the measurement of health status. The domains mobility, self-care, everyday activity, pain or physical discomfort, and fear or depression are assessed on a five-point scale, with 1 indicating no problem in this domain and 3 indicating extreme problems. The visual analogue scale ranges from 0 to 100, with 0 indicating the worst health imaginable and 100 the best health imaginable.	90 days and 1 year
Ordinal distribution of modified Rankin Scale (mRS) at 1 year	Ordinal distribution of modified Rankin Scale (mRS) 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.	1 year
The proportion of symptomatic intracranial hemorrhage	Symptomatic intracranial hemorrhage within 24 hours (as defined by Heidelberg criteria)	24 hours
The proportion of all-cause mortality	All-cause mortality at 90 days and 1 year	90 days and 1 year
The proportion of systematic bleeding	Moderate or severe systemic bleeding is defined according to the criteria established in the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO) trial	90 days
The proportion of serious adverse events (SAEs)	serious adverse events within 90 days	90 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of successful recanalization	The proportion of successful recanalization(eTICI 2b50-3) following EVT	immediately after the intervention
The proportion of improvement on reperfusion at 24 hours after randomization	Improvement on reperfusion is defined as >90% reduction in Tmax > 6s lesion volume	24 hours
The proportion of complete recanalization at 24 hours after randomization	Complete recanalization is defined as an Arterial Occlusion Lesion scale [AOL] score of 3 (scale range, 0 [no recanalization] to 3 [complete recanalization]).	24 hours

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Investigators: Principal Investigator: Yunyun Xiong, professor, Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2028

Study Registration Dates

• First Submitted: December 10, 2025
• First Submitted That Met QC Criteria: December 23, 2025
• First Posted (Actual): January 7, 2026

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 8, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: endovascular treatment; ischemic stroke; perfusion imaging; medium vessel occlusions
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: SQ2024QB01857

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No