Acute Ischemic StrokeSUPERSTARNCT07555977
SUPERSTAR: Aspiration vs. Stent Retriever in Anterior Circulation LVO
A study testing Super Large Bore Catheter and Stent Retriever Thrombectomy in people with Acute Ischemic Stroke, run by Shanghai Jiao Tong University Affiliated Sixth People's Hospital at 1 site in China.
Trial summary
This is a multicenter, open-label, blinded-endpoint, randomized controlled trial comparing super large bore catheter aspiration versus stent retriever thrombectomy as the first-line technique for anterior circulation large vessel occlusion in acute ischemic stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Super Large Bore Catheter and Stent Retriever Thrombectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 708 participants
- Where
- 1 siteChina
- Study dates
- 17 Sep 2026to 30 Mar 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;
- Clinically diagnosed with acute ischemic stroke, and pre-procedure imaging confirms that the culprit vessel is occlusion of the intracranial segment of the internal carotid artery and/or the middle cerebral artery M1 segment;
- Pre-stroke modified Rankin Scale (mRS) score of 0-1;
- Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥ 6;
- Alberta Stroke Program Early CT Score (ASPECTS) ≥ 3;
- Time from symptom onset to initiation of endovascular treatment (arterial puncture) < 24 hours; symptom onset time is defined as the "last known well" time;
- Intravenous thrombolysis and/or mechanical thrombectomy are performed according to local guidelines, and intravenous thrombolysis does not delay mechanical thrombectomy;
- Written informed consent is obtained from the patient or a family member.
Who cannot join
- Imaging shows acute or subacute intracranial hemorrhage (excluding microbleeds);
- Imaging indicates an intracranial tumor (excluding meningiomas <2 cm in diameter) or mass effect caused by a tumor, such as midline shift;
- Cerebral embolism caused by infection or bacterial endocarditis;
- The culprit vessel lesion is considered to be chronic atherosclerotic stenosis and occlusion;
- Pre-procedure imaging suggests that the lesion is due to dissection;
- Previous intracranial aneurysm or vascular malformation in the culprit vessel;
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- Presence of a life-threatening illness within 6 months that would prevent 3-month follow-up;
- Pregnancy, psychiatric illness, severe hepatic or renal insufficiency, severe heart failure;
- Concurrent participation in another clinical drug or device study;
- Metastatic tumor;
- Systemic infection;
- Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, 200233
Jiangshan Deng, PhD, 02164369181, johnson120@126.com
About this study
Official title: Super Large Bore Catheter Aspiration Versus Stent Retriever Thrombectomy as First Line Technique for Anterior Circulation Large Vessel Occlusion in Acute Ischemic Stroke
This is a multicenter, open-label, blinded-endpoint, randomized controlled trial comparing super large bore catheter aspiration versus stent retriever thrombectomy as the first-line technique for anterior circulation large vessel occlusion in acute ischemic stroke. Eligible patients with acute ischemic stroke due to internal carotid artery intracranial segment and/or middle cerebral artery M1 occlusion will be randomized 1:1 to receive either aspiration using a super large bore catheter (inner diameter ≥0.080 inch) or stent retriever thrombectomy (allowing balloon guiding catheters or intermediate catheters with inner diameter <0.080 inch). The primary outcome is the ordinal modified Rankin Scale score at 90 days post-procedure. Key secondary outcomes include the proportion of patients with mRS 0-2 at 90 days, change in NIHSS at 24 hours and 7 days, and various angiographic and safety endpoints. The trial plans to enroll 708 patients across approximately 30 centers in China. The total study duration is 24-36 months, with each patient participating for 3 months.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Super Large Bore Catheter, Stent Retriever Thrombectomy
- Keywords
- Endovascular thrombectomy, Super Large Bore Catheter, Acute Ischemic Stroke
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Super Large Bore CatheterProcedure or surgery
Also called SLBC
The SLBC group may switch to different super large bore aspiration catheters. Once the aspiration catheter contacts the thrombus, continuous negative pressure aspiration is maintained for 1 minute. A total of at least three aspiration attempts should be performed using aspiration catheters of different inner diameters. If the catheter fails to contact the thrombus despite using different inner diameter catheters, or if complete recanalization is not achieved after three attempts, or if new embolization occurs in the M2 segment or other vascular territories, the investigator may decide, as deemed necessary, to continue attempting with the original device or to use other techniques and devices for recanalization. In cases where angiography shows that the thrombus has migrated forward and can no longer be aspirated using a super large bore catheter, and continued thrombectomy is judged necessary, other rescue techniques may be used.
Stent Retriever ThrombectomyProcedure or surgery
Also called SRT
Stent retriever thrombectomy is performed as the first line approach. Allowed to employ adjunctive technology during the stent retriever passes according to physician preference, which may be combined with an aspiration catheter (inner diameter < 0.080 inch). The use of a large-bore aspiration catheter (inner diameter > 0.080 inch) is prohibited in this arm.
| Study group | Role | What they receive |
|---|---|---|
| Super Large Bore Catheter Aspiration | Experimental | A super large bore aspiration catheter with an inner diameter (ID) ≥0.080 inch is preferred as the first-line device for simple aspiration thrombectomy. Receives: Procedure: Super Large Bore Catheter |
| Stent Retriever Thrombectomy | Active comparator | Stent retriever thrombectomy is preferred as the first-line technique. Receives: Procedure: Stent Retriever Thrombectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ordinal modified Rankin Scale score
The modified Rankin Scale (mRS) is a 7-level ordered categorical scale that measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.
0 - No symptoms.
- - No significant disability. Able to carry out all usual activities, despite some symptoms.
- - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- - Moderate disability. Requires some help, but able to walk unassisted.
- - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
- - Dead. The higher scores mean a worse outcome.
Measured: 90 days (±7 days) post-procedure
Secondary outcomes (4)
Proportion of patients with modified Rankin Scale score 0-2
The modified Rankin Scale (mRS) is a 7-level ordered categorical scale that measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.
0 - No symptoms.
- - No significant disability. Able to carry out all usual activities, despite some symptoms.
- - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- - Moderate disability. Requires some help, but able to walk unassisted.
- - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
- - Dead. The higher scores mean a worse outcome. A modified Rankin Scale score 0-2 indicates independence.
Measured: 90 days (±7 days) post-procedure
Other binary classifications of modified Rankin Scale score
Modified Rankin Scale score 0-1 vs. 2-6, 0-3 vs. 4-6, 0-4 vs. 5-6, 0-5 vs. 6. The modified Rankin Scale (mRS) is a 7-level ordered categorical scale that measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.
0 - No symptoms.
- - No significant disability. Able to carry out all usual activities, despite some symptoms.
- - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- - Moderate disability. Requires some help, but able to walk unassisted.
- - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
- - Dead. The higher scores mean a worse outcome.
Measured: 90 ± 7 days post-procedure
Change in stroke severity (National Institutes of Health Stroke Scale score)
Change of NIHSS score at 24h from baseline. The NIHSS is a standardized, validated tool used to quantify the severity of neurological deficits in patients with acute stroke. Score range: 0 to 42 (higher scores indicate more severe stroke).
Measured: 24 hours post-procedure
Change in stroke severity (National Institutes of Health Stroke Scale score)
Change of NIHSS score at 7 days post-procedure or at discharge from baseline. The NIHSS is a standardized, validated tool used to quantify the severity of neurological deficits in patients with acute stroke. Score range: 0 to 42 (higher scores indicate more severe stroke).
Measured: 7 days post-procedure or at discharge (whichever occurs first)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start17 Sep 2026
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies 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
- 708 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University Affiliated Sixth People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yueqi Zhu, Shanghai Jiao Tong University Affiliated Sixth People's Hospital
- Investigators
- Yueqi Zhu, MD, Principal investigator, Shanghai Sixth Hospital Affiliated to Shanghai Jiaotong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07555977
- Sponsor's protocol ID
- SUPERSTAR 2.0
- Acronym
- SUPERSTAR
- Status last verified
- Oct 2026
- First submitted
- 15 Apr 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Super Large Bore Catheter Aspiration Versus Stent Retriever Thrombectomy as First Line Technique for Anterior Circulation Large Vessel Occlusion in Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT07555977
- Acronym / sponsor ID
- SUPERSTAR / SUPERSTAR 2.0
- Conditions
- Acute Ischemic Stroke
- Keywords
- Endovascular thrombectomy, Super Large Bore Catheter, Acute Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 708 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University Affiliated Sixth People's HospitalUniversity, hospital or other
- Study start
- 17 Sep 2026 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 29 Apr 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.
This is a multicenter, open-label, blinded-endpoint, randomized controlled trial comparing super large bore catheter aspiration versus stent retriever thrombectomy as the first-line technique for anterior circulation large vessel occlusion in acute ischemic stroke. Eligible patients with acute ischemic stroke due to internal carotid artery intracranial segment and/or middle cerebral artery M1 occlusion will be randomized 1:1 to receive either aspiration using a super large bore catheter (inner diameter ≥0.080 inch) or stent retriever thrombectomy (allowing balloon guiding catheters or intermediate catheters with inner diameter <0.080 inch). The primary outcome is the ordinal modified Rankin Scale score at 90 days post-procedure. Key secondary outcomes include the proportion of patients with mRS 0-2 at 90 days, change in NIHSS at 24 hours and 7 days, and various angiographic and safety endpoints. The trial plans to enroll 708 patients across approximately 30 centers in China. The total study duration is 24-36 months, with each patient participating for 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Super Large Bore Catheter Aspiration | Experimental | Procedure: Super Large Bore CatheterA super large bore aspiration catheter with an inner diameter (ID) ≥0.080 inch is preferred as the first-line device for simple aspiration thrombectomy. |
| Stent Retriever Thrombectomy | Active comparator | Procedure: Stent Retriever ThrombectomyStent retriever thrombectomy is preferred as the first-line technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years;
- Clinically diagnosed with acute ischemic stroke, and pre-procedure imaging confirms that the culprit vessel is occlusion of the intracranial segment of the internal carotid artery and/or the middle cerebral artery M1 segment;
- Pre-stroke modified Rankin Scale (mRS) score of 0-1;
- Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥ 6;
- Alberta Stroke Program Early CT Score (ASPECTS) ≥ 3;
Key exclusion criteria (12 listed)
- Imaging shows acute or subacute intracranial hemorrhage (excluding microbleeds);
- Imaging indicates an intracranial tumor (excluding meningiomas <2 cm in diameter) or mass effect caused by a tumor, such as midline shift;
- Cerebral embolism caused by infection or bacterial endocarditis;
- The culprit vessel lesion is considered to be chronic atherosclerotic stenosis and occlusion;
- Pre-procedure imaging suggests that the lesion is due to dissection;
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 |
|---|---|---|
| Super Large Bore CatheterAlso: SLBCThe SLBC group may switch to different super large bore aspiration catheters. Once the aspiration catheter contacts the thrombus, continuous negative pressure aspiration is maintained for 1 minute. A total of at least three aspiration attempts should be performed using aspiration catheters of different inner diameters. If the catheter fails to contact the thrombus despite using different inner diameter catheters, or if complete recanalization is not achieved after three attempts, or if new embolization occurs in the M2 segment or other vascular territories, the investigator may decide, as deemed necessary, to continue attempting with the original device or to use other techniques and devices for recanalization. In cases where angiography shows that the thrombus has migrated forward and can no longer be aspirated using a super large bore catheter, and continued thrombectomy is judged necessary, other rescue techniques may be used. | Procedure or surgery | Super Large Bore Catheter Aspiration |
| Stent Retriever ThrombectomyAlso: SRTStent retriever thrombectomy is performed as the first line approach. Allowed to employ adjunctive technology during the stent retriever passes according to physician preference, which may be combined with an aspiration catheter (inner diameter < 0.080 inch). The use of a large-bore aspiration catheter (inner diameter > 0.080 inch) is prohibited in this arm. | Procedure or surgery | Stent Retriever Thrombectomy |
Primary outcome
Ordinal modified Rankin Scale score
Time frame: 90 days (±7 days) post-procedure
The modified Rankin Scale (mRS) is a 7-level ordered categorical scale that measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. 0 - No symptoms. 1. - No significant disability. Able to carry out all usual activities, despite some symptoms. 2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. - Moderate disability. Requires some help, but able to walk unassisted. 4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. - Dead. The higher scores mean a worse outcome.
4 secondary outcomes
Proportion of patients with modified Rankin Scale score 0-2
Time frame: 90 days (±7 days) post-procedure
Other binary classifications of modified Rankin Scale score
Time frame: 90 ± 7 days post-procedure
Change in stroke severity (National Institutes of Health Stroke Scale score)
Time frame: 24 hours post-procedure
Change in stroke severity (National Institutes of Health Stroke Scale score)
Time frame: 7 days post-procedure or at discharge (whichever occurs first)
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 7 Oct 2026.
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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.
Yueqi Zhu, MD principal investigator
Shanghai Sixth Hospital Affiliated to Shanghai Jiaotong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Super Large Bore Catheter and Stent Retriever Thrombectomy in people with Acute Ischemic Stroke, run by Shanghai Jiao Tong University Affiliated Sixth People's Hospital at 1 site 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 8 inclusion and 12 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 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Yueqi Zhu, MD (18930173115, zhuyueqi@sjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ordinal modified Rankin Scale score (time frame: 90 days (±7 days) post-procedure). 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 7 Oct 2026.