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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Beijing Daxing District People's Hospital
RECRUITING
Beijing
Beijing tiantan hospital
RECRUITING
Beijing
Changle People's Hospital
RECRUITING
Changle
Xingtang County People's Hospital
RECRUITING
Longzhou
Luoyang Yiluo Hospital
RECRUITING
Luoyang
People's Hospital of Queshan
RECRUITING
Panlong
Contact Information
Primary
Yunyun Xiong, professor
xiongyunyun@bjtth.org
86-10-59978350
Time Frame
Start Date: 2026-02-08
Estimated Completion Date: 2028-09-30
Participants
Target number of participants: 568
Treatments
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.
Other: Best medical treatment (BMT)
Administration of BMT should be done according to routine clinical practice and current guidelines.
Related Therapeutic Areas
Sponsors
Leads: Beijing Tiantan Hospital

This content was sourced from clinicaltrials.gov