SUPERSTAR: Aspiration vs. Stent Retriever in Anterior Circulation LVO

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Study 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. 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.

Eligibility

Primary outcome measure(s)

• Ordinal modified Rankin Scale score — 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.

Trial sites (1)

More Shanghai Jiao Tong University Affiliated Sixth People's Hospital trials in China

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