Stroke IschemicARTS-PIVOTNCT07323368
Advancing Reperfusion Therapy for Ischemic Stroke: Perfusion-guided Endovascular Intervention for Medium Vessel Occlusion Therapy
A study testing Endovascular treatment and Best medical treatment (BMT) in people with Stroke Ischemic and Medium Vessel Occlusions, run by Beijing Tiantan Hospital at 6 sites in China.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke Ischemic, Medium Vessel Occlusions
- What is being tested?
- Endovascular treatment and Best medical treatment (BMT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 568 participants
- Where
- 6 sitesChina
- Study dates
- 8 Feb 2026to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Beijing tiantan hospital
Beijing, Beijing Municipality, 100070
Yunyun Xiong, professor, 86-10-59978350, xiongyunyun@bjtth.org
- Recruiting
Beijing Daxing District People's Hospital
Beijing, Beijing Municipality
Chunmiao Duan, 010-60283006, miao3252003@163.com
- Recruiting
Changle People's Hospital
Changle, Shandong
Ruiguang Liu, 0536-6222822, lrgys@126.com
- Recruiting
Xingtang County People's Hospital
Longzhou, Hebei
Yanxin Wang, 0311-82981231, bdaczfg@163.COM
- Recruiting
Luoyang Yiluo Hospital
Luoyang, Henan
Yajun Yang, 0379-82888808, sqyyj7119@163.com
- Recruiting
People's Hospital of Queshan
Panlong, Henan
Jianxin Xu, 0396-7068021, 249957242@qq.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke Ischemic, Medium Vessel Occlusions
- Being tested
- Endovascular treatment, Best medical treatment (BMT)
- Keywords
- ischemic stroke, medium vessel occlusions, endovascular treatment, perfusion imaging
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular treatmentProcedure or surgery
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Endovascular treatment |
| Best medical treatment (BMT) | Other | Administration of BMT should be done according to routine clinical practice and current guidelines. Receives: Drug: Best medical treatment (BMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year
The proportion of symptomatic intracranial hemorrhage
Symptomatic intracranial hemorrhage within 24 hours (as defined by Heidelberg criteria)
Measured: 24 hours
The proportion of all-cause mortality
All-cause mortality at 90 days and 1 year
Measured: 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
Measured: 90 days
The proportion of serious adverse events (SAEs)
serious adverse events within 90 days
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start8 Feb 2026
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke IschemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 568 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunyun Xiong, Beijing Tiantan Hospital
- Investigators
- Yunyun Xiong, professor, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07323368
- Sponsor's protocol ID
- SQ2024QB01857
- Acronym
- ARTS-PIVOT
- Status last verified
- Feb 2026
- First submitted
- 10 Dec 2025
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing Reperfusion Therapy for Ischemic Stroke (ARTS): Perfusion-guided Endovascular Intervention for Medium Vessel Occlusion Therapy (PIVOT)
- ClinicalTrials.gov ID
- NCT07323368
- Acronym / sponsor ID
- ARTS-PIVOT / SQ2024QB01857
- Conditions
- Stroke Ischemic, Medium Vessel Occlusions
- Keywords
- ischemic stroke, medium vessel occlusions, endovascular treatment, perfusion imaging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 568 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 8 Feb 2026 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endovascular treatment (EVT) +Best medical treatment | Experimental | Procedure: Endovascular treatmentThe 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. |
| Best medical treatment (BMT) | Other | Drug: Best medical treatment (BMT)Administration of BMT should be done according to routine clinical practice and current guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endovascular treatmentEVT included thrombectomy with stent retrievers, thromboaspiration, intraarterial thrombolysis, balloon angioplasty, stenting, or a combination of these approaches at the discretion of the interventional team. | Procedure or surgery | Endovascular treatment (EVT) +Best medical treatment |
| 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. | Drug | Best medical treatment (BMT) |
Primary outcome
The proportion of patients who have a score of 0 or 1 on the modified Rankin Scale (mRS) at 90 days
Time frame: 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.
10 secondary outcomes
Ordinal distribution of modified Rankin Scale (mRS) at 90 days
Time frame: 90 days
The proportion of patients with an modified Rankin Scale (mRS) score of 0-2 at 90 days
Time frame: 90 days
The rate of early neurological improvement at 24 hours
Time frame: 24 hours
The proportion of patients with an modified Rankin Scale (mRS) score of 5-6 at 90 days
Time frame: 90 days
The median value of EuroQol 5-Dimension (EQ-5D) index
Time frame: 90 days and 1 year
Ordinal distribution of modified Rankin Scale (mRS) at 1 year
Time frame: 1 year
The proportion of symptomatic intracranial hemorrhage
Time frame: 24 hours
The proportion of all-cause mortality
Time frame: 90 days and 1 year
The proportion of systematic bleeding
Time frame: 90 days
The proportion of serious adverse events (SAEs)
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yunyun Xiong, professor principal investigator
Beijing Tiantan Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endovascular treatment and Best medical treatment (BMT) in people with Stroke Ischemic and Medium Vessel Occlusions, run by Beijing Tiantan Hospital at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yunyun Xiong, professor (86-10-59978350, xiongyunyun@bjtth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients who have a score of 0 or 1 on the modified Rankin Scale (mRS) at 90 days (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.