SUPERSTAR: Aspiration vs. Stent Retriever in Anterior Circulation LVO

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

Overview

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

• 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 embol
• 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.

Primary outcome measures

• Ordinal modified Rankin Scale score [Time frame: 90 days (±7 days) post-procedure]

Secondary outcome measures (4)

• 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)]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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;
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07555977 · SUPERSTAR 2.0

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗