RECRUITING Not applicable ClinicalTrials.gov

SUPERSTAR: Aspiration vs. Stent Retriever in Anterior Circulation LVO

Sponsor: Shanghai Jiao Tong University Affiliated Sixth People's Hospital • ClinicalTrials.gov ID: NCT07555977

Registry updated: 2026-10-07

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

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.

Interventions

Super Large Bore Catheter (Procedure)
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 Thrombectomy (Procedure)
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.

Eligibility criteria

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.

Conditions

Acute Ischemic Stroke

Locations

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, China

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment