SUPERSTAR: Aspiration vs. Stent Retriever in Anterior Circulation LVO (SUPERSTAR)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Procedure: Super Large Bore Catheter; Procedure: Stent Retriever Thrombectomy

• Study Type: Interventional
• Enrollment (Estimated): 708
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yueqi Zhu, MD; Phone Number: 18930173115; Email: zhuyueqi@sjtu.edu.cn
• Study Contact Backup: Name: Jiangshan Deng, MD; Phone Number: 18817822181; Email: jiangshandeng@sjtu.edu.cn

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Age ≥ 18 years;
2. 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;
3. Pre-stroke modified Rankin Scale (mRS) score of 0-1;
4. Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥ 6;
5. Alberta Stroke Program Early CT Score (ASPECTS) ≥ 3;
6. Time from symptom onset to initiation of endovascular treatment (arterial puncture) < 24 hours; symptom onset time is defined as the "last known well" time;
7. Intravenous thrombolysis and/or mechanical thrombectomy are performed according to local guidelines, and intravenous thrombolysis does not delay mechanical thrombectomy;
8. Written informed consent is obtained from the patient or a family member.

Exclusion Criteria:

1. Imaging shows acute or subacute intracranial hemorrhage (excluding microbleeds);
2. Imaging indicates an intracranial tumor (excluding meningiomas <2 cm in diameter) or mass effect caused by a tumor, such as midline shift;
3. Cerebral embolism caused by infection or bacterial endocarditis;
4. The culprit vessel lesion is considered to be chronic atherosclerotic stenosis and occlusion;
5. Pre-procedure imaging suggests that the lesion is due to dissection;
6. Previous intracranial aneurysm or vascular malformation in the culprit vessel;
7. Presence of a life-threatening illness within 6 months that would prevent 3-month follow-up;
8. Pregnancy, psychiatric illness, severe hepatic or renal insufficiency, severe heart failure;
9. Concurrent participation in another clinical drug or device study;
10. Metastatic tumor;
11. Systemic infection;
12. Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study.

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: Super Large Bore Catheter Aspiration; 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.	Procedure: Super Large Bore Catheter; 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.; Other Names: SLBC
Active Comparator: Stent Retriever Thrombectomy; Stent retriever thrombectomy is preferred as the first-line technique.	Procedure: Stent Retriever Thrombectomy; 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.; Other Names: SRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	90 days (±7 days) post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	24 hours post-procedure
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.	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.	90 ± 7 days 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).	7 days post-procedure or at discharge (whichever occurs first)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aspiration catheter delivery success rate	Defined as successful delivery of the aspiration catheter to the target occluded vessel, contacting the tail of the thrombus, or contacting the tail of the stent retriever before retrieval.	During the procedure
Final angiographic reperfusion status	eTICI 0 - No reperfusion. eTICI 1 - Minimal reperfusion (flow past the occlusion but no distal branch filling). eTICI 2a - Reperfusion <50% of the occluded target artery territory. eTICI 2b - Reperfusion ≥50% but <90%. eTICI 2c - Reperfusion ≥90% (near complete, only slow flow or small distal clot). eTICI 3 - Complete (100%) reperfusion.	Immediately after procedure
Reperfusion status after first-line technique thrombectomy	eTICI 0 - No reperfusion. eTICI 1 - Minimal reperfusion (flow past the occlusion but no distal branch filling). eTICI 2a - Reperfusion <50% of the occluded target artery territory. eTICI 2b - Reperfusion ≥50% but <90%. eTICI 2c - Reperfusion ≥90% (near complete, only slow flow or small distal clot). eTICI 3 - Complete (100%) reperfusion.	During the procedure after the first thrombectomy
Time from arterial puncture to successful reperfusion (≥ eTICI 2b)	Successful reperfusion defined as reperfusion status ≥ eTICI 2b	During the procedure, successful reperfusion (≥ eTICI 2b) achieved
Time from arterial puncture to successful reperfusion (≥ eTICI 2c)	Successful reperfusion defined as reperfusion status ≥ eTICI 2c	During the procedure, successful reperfusion (≥ eTICI 2c) achieved
Proportion of patients achieving reperfusion (≥ eTICI 2b) within 45 minutes of puncture	Achieving revascularization defined as reperfusion status ≥ eTICI 2b	During the procedure, the time from puncture to reperfusion (≥ eTICI 2b) achieved
Proportion of patients achieving reperfusion (≥ eTICI 2c) within 45 minutes of puncture	Achieving revascularization defined as reperfusion status ≥ eTICI 2c	During the procedure, the time from puncture to reperfusion (≥ eTICI 2c) achieved
Proportion of patients achieving revascularization (eTICI 3) within 45 minutes of puncture	Achieving revascularization defined as reperfusion status with eTICI 3	During the procedure, the time from puncture to reperfusion (≥ eTICI 2c) achieved
Total number of final thrombectomy passes to achieve successful recanalization	Successful recanalization defined as reperfusion status≥ eTICI 2c)	During the procedure
Proportion of patients with embolization to a new territory (non-culprit vascular territory)	Embolization to a new territory not within the artery of thrombectomy	During the procedure
Proportion of patients with distal embolization of the culprit vessel territory	Embolization to the distal area of the culprit artery	During the procedure
First-pass successful reperfusion rate	First-pass successful reperfusion defined as reperfusion ≥90% (eTICI 2c) after first pass.	During the procedure after the first thrombectomy

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
• Investigators: Principal Investigator: Yueqi Zhu, MD, Shanghai Sixth Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): August 30, 2028

Study Registration Dates

• First Submitted: April 15, 2026
• First Submitted That Met QC Criteria: April 22, 2026
• First Posted (Actual): April 29, 2026

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Acute Ischemic Stroke; Endovascular thrombectomy; Super Large Bore Catheter
• 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: SUPERSTAR 2.0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No