Acute Ischemic StrokeNCT06559475
A Multicenter, Randomized Controlled Clinical Investigation to Evaluate the Safety and Effectiveness of the Super-Bore 8/7F Aspiration Catheters in the Treatment of Acute Intracranial Large Vessel Occlusion
A study testing Super-Bore Thrombosis Aspiration Catheter treatment group and Conventional thrombectomy device treatment group in people with Acute Ischemic Stroke and Endovascular Thrombectomy, run by The First Affiliated Hospital of University of Science and Technology of China at 1 site in China.
Trial summary
To Evaluate the Safety and Efficacy of the Super-Bore 8/7F Thrombosis Aspiration Catheter in the Treatment of Acute Intracranial Large Vessel Occlusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke, Endovascular Thrombectomy
- What is being tested?
- Super-Bore Thrombosis Aspiration Catheter treatment group and Conventional thrombectomy device treatment group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- 16 Dec 2024to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older;
- Clinical presentation consistent with acute ischemic stroke (AIS);
- Able to receive mechanical thrombectomy within 24 hours of onset;
- Pre-morbid mRS score of 0 or 1;
- Baseline NIHSS score of 6 or greater;
- Complete or near-complete occlusion (eTICI 0-1) of the intracranial segment of the internal carotid artery (ICA), the M1 segment of the middle cerebral artery (MCA), or the basilar artery (with or without involvement of the intracranial vertebral artery) confirmed by angiography who can undergo intravascular thrombectomy;
Show all 9Show fewer
- Vessel diameter ≥2.2 mm at the occlusion site;
- ASPECTS or PC-ASPECTS score of 6-10 on NCCT, CTA-source imaging, or DWI-MRI;
- Written informed consent obtained from the patient or the patient's qualified representative.
Who cannot join
- Pregnant or lactating women;
- Severe allergic reactions to contrast agents;
- Current participation in other clinical studies;
- Known hereditary or acquired bleeding disorders, platelet count <50,000/µL, or coagulation factor deficiencies;
- Renal failure with serum creatinine ≥3 mg/dL or Glomerular Filtration Rate (GFR) <30 mL/min;
- Expected survival < 6 months or known cancer with metastases;
Show all 22Show fewer
- Clinical manifestations suggesting subarachnoid hemorrhage, despite normal CT or MRI findings;
- Suspected aortic dissection;
- Known arterial condition in a proximal vessel that requires treatment or prevents access to the site of occlusion or safe recovery of the investigational device (for example, severe stenosis, complete occlusion in the cervical ICA, tandem occlusion);
- High degree of suspicion of intracranial arterial disease (ICAD), such as evidence of multifocal ICAD on CTA, MRA, or DSA, or any other finding that is highly suggestive of ICAD as the underlying etiology of the occlusion;
- Evidence of dissection in the extracranial or intracranial cerebral arteries;
- Intracranial hemorrhage on CT or MRI;
- Evidence of intracranial mass effect or tumor (except small meningiomas defined as ≤ 3cm and asymptomatic)) on CT or MRI;
- Suspicious of cerebral vasculitis or infectious endocarditis;
- Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluation, e.g., dementia with prescribed anti-cholinesterase inhibitor;
- Clinical history, past imaging or clinical judgement suggest that the intracranial occlusion is chronic;
- Excessive vascular access tortuosity or target vessel size that will likely prevent endovascular access with the Super-Bore Aspiration Catheters;
- Intracranial stent implanted in the same vascular territory that would preclude the safe deployment/removal of the thrombectomy devices;
- Occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior circulation/vertebrobasilar system) as confirmed on CTA/MRA, or clinical evidence of bilateral strokes or strokes in multiple territories as determined by the treating physician;
- Known aneurysm at or near the target treatment segment;
- Known glucose level< 50 mg/dl (2.78 mmol/L) or > 400 mg/dl (22.20 mmol/L)；
- Patients who, in the opinion of the investigator, are unsuitable for mechanical thrombectomy as evidenced by imaging findings.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui
Wei Hu, MD,PhD, +8615155510611, andinghu@ustc.edu.cn
About this study
To Evaluate the Safety and Efficacy of the Super-Bore 8/7F Thrombosis Aspiration Catheter in the Treatment of Acute Intracranial Large Vessel Occlusion.
- Conditions
- Acute Ischemic Stroke, Endovascular Thrombectomy
- Being tested
- Super-Bore Thrombosis Aspiration Catheter treatment group, Conventional thrombectomy device treatment group
- Keywords
- Acute Ischemic Stroke, Super-Bore 8F Thrombosis Aspiration Catheter, Acute Intracranial Large Vessel Occlusion
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Super-Bore Thrombosis Aspiration Catheter treatment groupProcedure or surgery
For the subjects randomized to the Super-Bore Thrombosis Aspiration Catheter treatment group, Mechanical thrombectomy will be performed using a Super-Bore 8/7F Thrombosis Aspiration Catheter.
Conventional thrombectomy device treatment groupProcedure or surgery
For the subjects randomized to the conventional thrombectomy device treatment group, mechanical thrombectomy will be performed using a commonly used thrombectomy devices in clinic, except for Super-Bore 8/7F Thrombosis Aspiration Catheter.
| Study group | Role | What they receive |
|---|---|---|
| Super-Bore Thrombosis Aspiration Catheter treatment group | Experimental | For the subjects randomized to the Super-Bore Thrombosis Aspiration Catheter treatment group, mechanical thrombectomy will be performed using a Super-Bore 8/7F Thrombosis Aspiration Catheter. Receives: Procedure: Super-Bore Thrombosis Aspiration Catheter treatment group |
| Conventional thrombectomy device treatment group | Active comparator | For the subjects randomized to the conventional thrombectomy device treatment group, mechanical thrombectomy will be performed using a commonly used thrombectomy devices in clinic, except for Super-Bore 8/7F Thrombosis Aspiration Catheter. Receives: Procedure: Conventional thrombectomy device treatment group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Rates of First Pass Effect (eTICI2c-3)
Evaluate effect of thrombectomy on reperfusion
Measured: Within 5 minutes at final angiography of thrombectomy
Secondary outcomes (2)
Proportion of mRS 0-2 at 90 days
Modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)
Measured: 90 (± 14 days) after procedure
90-day Global Disability Assessed Via the Blinded Evaluation of Modified Rankin Score (Ordinal Shift Analysis);
Modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)
Measured: 90 (± 14 days) after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start16 Dec 2024 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of University of Science and Technology of China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Hu, The First Affiliated Hospital of University of Science and Technology of China
- Investigators
- Wei Hu, MD, PhD, Study chair, The First Affiliated Hospital of University of Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06559475
- Sponsor's protocol ID
- Super Aspiration
- Status last verified
- Dec 2024
- First submitted
- 15 Aug 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized Controlled Clinical Investigation to Evaluate the Safety and Effectiveness of the Super-Bore 8/7F Aspiration Catheters in the Treatment of Acute Intracranial Large Vessel Occlusion
- ClinicalTrials.gov ID
- NCT06559475
- Acronym / sponsor ID
- Super Aspiration
- Conditions
- Acute Ischemic Stroke, Endovascular Thrombectomy
- Keywords
- Acute Ischemic Stroke, Super-Bore 8F Thrombosis Aspiration Catheter, Acute Intracranial Large Vessel Occlusion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of University of Science and Technology of ChinaUniversity, hospital or other
- Study start
- 16 Dec 2024 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 19 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To Evaluate the Safety and Efficacy of the Super-Bore 8/7F Thrombosis Aspiration Catheter in the Treatment of Acute Intracranial Large Vessel Occlusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Super-Bore Thrombosis Aspiration Catheter treatment group | Experimental | Procedure: Super-Bore Thrombosis Aspiration Catheter treatment groupFor the subjects randomized to the Super-Bore Thrombosis Aspiration Catheter treatment group, mechanical thrombectomy will be performed using a Super-Bore 8/7F Thrombosis Aspiration Catheter. |
| Conventional thrombectomy device treatment group | Active comparator | Procedure: Conventional thrombectomy device treatment groupFor the subjects randomized to the conventional thrombectomy device treatment group, mechanical thrombectomy will be performed using a commonly used thrombectomy devices in clinic, except for Super-Bore 8/7F Thrombosis Aspiration Catheter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged 18 years or older;
- Clinical presentation consistent with acute ischemic stroke (AIS);
- Able to receive mechanical thrombectomy within 24 hours of onset;
- Pre-morbid mRS score of 0 or 1;
- Baseline NIHSS score of 6 or greater;
Key exclusion criteria (22 listed)
- Pregnant or lactating women;
- Severe allergic reactions to contrast agents;
- Current participation in other clinical studies;
- Known hereditary or acquired bleeding disorders, platelet count <50,000/µL, or coagulation factor deficiencies;
- Renal failure with serum creatinine ≥3 mg/dL or Glomerular Filtration Rate (GFR) <30 mL/min;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Super-Bore Thrombosis Aspiration Catheter treatment groupFor the subjects randomized to the Super-Bore Thrombosis Aspiration Catheter treatment group, Mechanical thrombectomy will be performed using a Super-Bore 8/7F Thrombosis Aspiration Catheter. | Procedure or surgery | Super-Bore Thrombosis Aspiration Catheter treatment group |
| Conventional thrombectomy device treatment groupFor the subjects randomized to the conventional thrombectomy device treatment group, mechanical thrombectomy will be performed using a commonly used thrombectomy devices in clinic, except for Super-Bore 8/7F Thrombosis Aspiration Catheter. | Procedure or surgery | Conventional thrombectomy device treatment group |
Primary outcome
The Rates of First Pass Effect (eTICI2c-3)
Time frame: Within 5 minutes at final angiography of thrombectomy
Evaluate effect of thrombectomy on reperfusion
2 secondary outcomes
Proportion of mRS 0-2 at 90 days
Time frame: 90 (± 14 days) after procedure
90-day Global Disability Assessed Via the Blinded Evaluation of Modified Rankin Score (Ordinal Shift Analysis);
Time frame: 90 (± 14 days) after procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Acute Ischemic Stroke
Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
Ischemic Stroke
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
Not yet recruitingPhase 3
INTRA-ARTERIAL MeVO TREATMENT (IMP-ACT) Within the ACT-GLOBAL Adaptive Platform Trial-NCT06352632
Stroke, Acute Ischemic, Medium Vessel Occlusion
Not yet recruitingPhase 2/3
A Phase II/III Clinical Study of SIM0811 in the Treatment of Acute Ischemic Stroke
Acute Ischemic Stroke AIS
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wei Hu, MD, PhD study chair
The First Affiliated Hospital of University of Science and Technology of China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Super-Bore Thrombosis Aspiration Catheter treatment group and Conventional thrombectomy device treatment group in people with Acute Ischemic Stroke and Endovascular Thrombectomy, run by The First Affiliated Hospital of University of Science and Technology of China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei Hu, MD, PhD (+86 055162284313, andinghu@ustc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Rates of First Pass Effect (eTICI2c-3) (time frame: Within 5 minutes at final angiography of thrombectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.