Clinical trial NCT05615038: A Comparison of Contact Aspiration Versus Stent Retriever for Acute Basilar Artery Occlusion
Official title: A Comparison of Contact Aspiration Versus Stent Retriever for Acute Basilar Artery Occlusion: A Multicentre, Prospective, Open-label, Blind Endpoint, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Basilar Artery Occlusion
Endovascular Treatment
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 338
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Compare the effectiveness and safety of contact aspiration (CA) and stent retriever (SR) in acute ischemic stroke patients with basilar artery occlusion.


Eligibility criteria: Inclusion Criteria:

1. Age≥18 years;
2. Acute basilar artery occlusion confirmed by CTA/MRA/DSA;
3. Last known well to puncture time≤24 hours;
4. pc-ASPECTS score≥6 points;
5. Baseline NIHSS score≥10 points;
6. Consent to endovascular treatment;
7. Informed consent signed.

Clinical Exclusion Criteria:

1. Baseline mRS≥3 points;
2. Known or suspected severe basilar artery stenosis (\>70%) or chronic occlusion based on history, imaging, or clinical manifestations;
3. Refractory hypertension that is difficult to be controlled by drugs (defined as persistent systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg)
4. Genetic or acquired hemorrhagic tendency, coagulation factor deficiency or on anticoagulant therapy and International Normalized Ratio (INR) \> 3.0;
5. Laboratory tests: baseline blood glucose \<50mg/dl (2.8mmol/L) or \>400mg/dl (22.2mmol/L); Baseline platelet count \<50×109/L;
6. Known severe allergy (more severe than skin rash) to contrast agents uncontrolled by medications;
7. Females who are pregnant, or those of childbearing, potential with positive urine or serum beta Human Chorionic Gonadotropin test;
8. Other circumstances that the investigator considers inappropriate for participation in the trial or that may pose significant risks to patients (such as inability to understand and/or follow the study procedures and/or follow up due to mental disorders, cognitive or emotional disorders).

Imaging Exclusion Criteria:

1. CT or MR evidence of acute intracranial hemorrhage (the presence of microbleeds on MRI is allowed);
2. Midline shift or herniation, mass effect with effacement of the ventricles;
3. Complete cerebellar infarct on CT or MRI with significant mass effect and compression of the 4-th ventricle;
4. Complete bilateral thalamic infarction on CT or MRI;
5. Inability to endovascular treatment due to Excessive tortuosity, variation, or dissection of the artery;
6. Subjects with occlusions in both intracranial vertebral arteries;
7. Subjects with occlusions in both anterior and posterior circulation;
8. Evidence of intracranial tumor (except small meningioma).

Primary outcomes:
measure: Rate of first pass effect (FPE)
timeFrame: 24 hours
Secondary outcomes:
measure: Rate of complete reperfusion (eTICI 3) after first-line thrombectomy strategy and at the end of endovascular procedure
timeFrame: 24 hours
measure: Rate of near to complete reperfusion (eTICI 2c/3) after first-line thrombectomy strategy and at the end of endovascular procedure
timeFrame: 24 hours
measure: Rate of successful reperfusion (eTICI 2b/2c/3) after first-line thrombectomy strategy and at the end of endovascular procedure
timeFrame: 24 hours
measure: Rate of Arterial Occlusive Lesion (AOL) recanalization score 3 after first-line thrombectomy strategy and at the end of endovascular procedure
timeFrame: 24 hours
measure: Groin puncture time to successful reperfusion time (min)
timeFrame: 24 hours
measure: The difference of NIHSS score between 24-hour and baseline
timeFrame: 24 hours
measure: Modified Rankin Score (mRS) at 90±14 days (shift analysis)
timeFrame: 90 days
measure: Rate of mRS 0-1 at at 90±14 days
timeFrame: 90 days
measure: Rate of mRS 0-2 at at 90±14 days
timeFrame: 90 days
measure: Rate of mRS 0-3 at at 90±14 days
timeFrame: 90 days
measure: Quality of life at 90±14 days assessed by EuroQol 5D-5L scale
timeFrame: 90 days
measure: Rate of symptomatic intracranial hemorrhage within 48 hours (according to Heidelberg Bleeding Classification)
timeFrame: 48 hours
measure: Rate of any intracranial hemorrhage within 48 hours (according to Heidelberg Bleeding Classification)
timeFrame: 48 hours
measure: Rate of procedure-related complications, included arterial dissection, embolization in a new territory, arterial perforation and subarachnoid haemorrhage
timeFrame: 24 hours
measure: All cause of mortality at 90±14 days
timeFrame: 90 days
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Beijing Anzhen Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Daxing District People's Hospital
state: Beijing
city: Anyang
country: China
facility: Anyang People's Hospital
state: Henan
city: Zhangzhou
country: China
facility: Zhangzhou Municipal Hospital
state: Henan
city: Baotou
country: China
facility: Baotou Center Hospital
state: Neimenggu
Study officials:
References: