Actively Recruiting
Advancing Reperfusion Therapy for Ischemic Stroke (ARTS): Perfusion-guided Endovascular Intervention for Medium Vessel Occlusion Therapy (PIVOT)
Led by Beijing Tiantan Hospital · Updated on 2026-02-10
568
Participants Needed
6
Research Sites
52 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of perfusion-guided endovascular treatment (EVT) compared to standard medical care for adults who have had an acute ischemic stroke caused by medium vessel occlusion within 24 hours of symptom onset. This study focuses on patients with specific artery blockages confirmed by imaging and a baseline stroke severity score of 8 or higher. The goal is to see how well patients recover by measuring their ability to function independently 90 days after treatment. Participants will be randomly assigned to one of two groups: one receiving endovascular treatment plus best medical treatment, and the other receiving best medical treatment alone. The endovascular treatment involves techniques such as thrombectomy, thromboaspiration, intraarterial thrombolysis, balloon angioplasty, stenting, or combinations of these, performed immediately after randomization. Best medical treatment follows current clinical guidelines and is administered independently of the study treatment. During the study, participants will undergo neuroimaging to confirm eligibility and will be monitored regularly for neurological improvement, safety events, and overall recovery using scales like the modified Rankin Scale at 90 days and one year. Researchers will collect data on stroke severity, quality of life, bleeding complications, and mortality. The study starts in February 2026 and continues until September 2028, with participant follow-up lasting at least one year after treatment.
CONDITIONS
Brief Title
Advancing Reperfusion Therapy for Ischemic Stroke: Perfusion-guided Endovascular Intervention for Medium Vessel Occlusion Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Acute ischemic stroke symptom onset within 24 hours, including wake-up and unwitnessed strokes
- Medium vessel occlusion confirmed by CTA or MRA affecting specified brain artery segments
- Pre-stroke modified Rankin Scale score of 1 or less
- Baseline National Institutes of Health Stroke Scale (NIHSS) score of 8 or higher
- Target mismatch profile on CT perfusion or MRI+MR perfusion (ischemic core volume less than 70 mL, mismatch ratio greater than 1.2, mismatch volume greater than 10 mL)
- Signed informed consent from patient or legal representative
You will not qualify if you...
- Any intracranial hemorrhage seen on imaging
- Known serious allergy to contrast agents, nickel, titanium, or inability to complete required imaging
- Arterial conditions preventing safe device access or recovery after EVT
- Presence of brain mass effect or tumor (except small meningioma)
- Diagnosis of cerebral vasculitis
- Vessel recanalization before randomization
- Severe other illnesses likely to prevent recovery or follow-up
- Terminal illness with expected survival less than one year
- Large hypodensity in more than one-third of the MCA territory or signs of distal clot migration
- Multiple arterial occlusions
- Pregnancy, breastfeeding, or unwillingness to use effective contraception during the trial
- Unlikely to follow trial protocol or attend follow-up
- Participation in other interventional trials within last 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 hours after symptom onset
Participants receive either endovascular treatment combined with best medical treatment or best medical treatment alone within 24 hours after symptom onset.
1 treatment visit (in-person)
Duration - Up to 1 year
Participants are monitored and assessed for recovery and safety outcomes up to 1 year after treatment.
Visits at 24 hours, 90 days, and 1 year (in-person or remote)
Trial Site Locations
Total: 6 locations
1
Beijing tiantan hospital
Beijing, Beijing Municipality, China, 100070
Actively Recruiting
2
Beijing Daxing District People's Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
3
Xingtang County People's Hospital
Longzhou, Hebei, China
Actively Recruiting
4
Luoyang Yiluo Hospital
Luoyang, Henan, China
Actively Recruiting
5
People's Hospital of Queshan
Panlong, Henan, China
Actively Recruiting
6
Changle People's Hospital
Changle, Shandong, China
Actively Recruiting
Research Team
Y
Yunyun Xiong, professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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