Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07555977

SUPERSTAR: Aspiration vs. Stent Retriever in Anterior Circulation LVO

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: SLBC

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.

Other names: SRT

Primary outcomes

  1. 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.

    • - 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.

Secondary outcomes

  1. Proportion of patients with modified Rankin Scale score 0-2

    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.

    • - 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.

  2. Other binary classifications of modified Rankin Scale score

    Time frame: 90 ± 7 days post-procedure

    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.

  3. Change in stroke severity (National Institutes of Health Stroke Scale score)

    Time frame: 24 hours post-procedure

    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).

  4. Change in stroke severity (National Institutes of Health Stroke Scale score)

    Time frame: 7 days post-procedure or at discharge (whichever occurs first)

    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).

Other outcomes

  1. Aspiration catheter delivery success rate

    Time frame: During the procedure

    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.

  2. Final angiographic reperfusion status

    Time frame: Immediately after procedure

    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.

  3. Reperfusion status after first-line technique thrombectomy

    Time frame: During the procedure after the 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.

  4. First-pass successful reperfusion rate

    Time frame: During the procedure after the first thrombectomy

    First-pass successful reperfusion defined as reperfusion ≥90% (eTICI 2c) after first pass.

  5. Time from arterial puncture to successful reperfusion (≥ eTICI 2b)

    Time frame: During the procedure, time from puncture to successful reperfusion (≥ eTICI 2b) achieved

    Successful reperfusion defined as reperfusion status ≥ eTICI 2b

  6. Time from arterial puncture to successful reperfusion (≥ eTICI 2c)

    Time frame: During the procedure, time from puncture to successful reperfusion (≥ eTICI 2c) achieved

    Successful reperfusion defined as reperfusion status ≥ eTICI 2c

  7. Proportion of patients achieving reperfusion (≥ eTICI 2b) within 45 minutes of puncture

    Time frame: During the procedure, 45 minutes after puncture.

    Achieving revascularization defined as reperfusion status ≥ eTICI 2b

  8. Proportion of patients achieving reperfusion (≥ eTICI 2c) within 45 minutes of puncture

    Time frame: During the procedure, 45 minutes after puncture.

    Achieving revascularization defined as reperfusion status ≥ eTICI 2c

  9. Proportion of patients achieving revascularization (eTICI 3) within 45 minutes of puncture

    Time frame: During the procedure, 45 minutes after puncture.

    Achieving revascularization defined as reperfusion status with eTICI 3

  10. Total number of final thrombectomy passes to achieve successful recanalization

    Time frame: During the procedure

    Successful recanalization defined as reperfusion status≥ eTICI 2c)

  11. Proportion of patients with embolization to a new territory (non-culprit vascular territory)

    Time frame: During the procedure

    Embolization to a new territory not within the artery of thrombectomy

  12. Proportion of patients with distal embolization of the culprit vessel territory

    Time frame: During the procedure

    Embolization to the distal area of the culprit artery

Study contacts

Contact information is provided by the study sponsor or research team.

Jiangshan Deng, MD

CONTACT

[email protected]

18817822181

Yueqi Zhu, MD

CONTACT

[email protected]

18930173115

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Other

Registry information

Official study title

Super Large Bore Catheter Aspiration Versus Stent Retriever Thrombectomy as First Line Technique for Anterior Circulation Large Vessel Occlusion in Acute Ischemic Stroke

Acronym: SUPERSTAR

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 29, 2026
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.