Prospective Registry of Endovascular Thrombectomy for eXtra-Large Ischemic Stroke

ConditionsAcute Ischemic Stroke (AIS)Acute Ischemic Stroke From Large Vessel Occlusion

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorZhongming Qiu

About this trial

Since 2015, many randomized trials have shown that endovascular thrombectomy improve functional outcomes in acute ischemic stroke patients with large vessel occlusion. Recently, five randomized controlled trials (ANGEL-ASPECT \[Endovascular Therapy in Acute Anterior Circulation Large Vessel Occlusive Patients with a Large Infarct Core\], LASTE \[LArge Stroke Therapy Evaluation\], RESCUE-Japan LIMIT \[The Recovery by Endovascular Salvage for Cerebral Ultra-Acute Embolism-Japan Large Ischemic Core Trial\], SELECT 2 \[Randomized Controlled Trial to Optimize Patient's Selection for Endovascular Treatment in Acute Ischemic Stroke\], and TENSION \[The Efficacy and Safety of Thrombectomy in Stroke with extended lesion and extended time window\]) demonstrated the efficacy and safety of thrombectomy for large infarct patients (defined as Alberta Stroke Program Early Computed Tomography Score \[ASPECTS\] ≥3 or infarct core \<100ml). Patients with extra-large infarct core (ASPECTS score of 2 or less) were excluded from these trials. Therefore, the efficacy of endovascular thrombectomy in patients with extra-large ischemic burden has not been well studied. The XL STROKE registry is aiming to investigate the clinical outcomes and safety of mechanical thrombectomy in acute extra-large ischemic stroke.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years;

Presenting with acute ischemic stroke within 24 hours of time from last known well;

The patient or patient's representative signs a written informed consent form before enrollment.

Occlusion of internal carotid artery, or the middle cerebral artery M1 or M2 segments confirmed by computed tomography angiography, magnetic resonance angiography, or digital subtraction angiography;

Disqualifiers

CT or MRI evidence of acute intracranial hemorrhage;

Evidence of mass effect with ventricular effacement, midline shift or herniation on baseline imaging;

Females who are pregnant, or those of childbearing, potential with positive urine or serum beta Human Chorionic Gonadotropin test;

Previous bleeding disorders, severe heart, liver or kidney disease, or sepsis;

Trial population

All patients are presented with acute extra-large stroke and large vessel occlusion within 24 hours of time from last known well.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

medical management
Other intervention
Medical management will be based on the recommendations of the stroke management guidelines of the Chinese Stroke Association. Patients will receive intravenous thrombolysis according to the guidelines if they are eligible for thrombolysis. Patients who are not treated with intravenous thrombolysis will be treated with aspirin, unless an indication for early anticoagulation is present.
endovascular thrombectomy
Other intervention
The use of devices (i.e. stent-retriever, aspiration catheter) is at the discretion of neurointerventionalist. Intra-arterial administration of alteplase, tenecteplase, tirofiban, angioplasty and stenting will also be permitted.

Treatment groups

1,000 Participants

are divided into 2 treatment groups

Group A: Endovascular thrombectomy2 interventions

Group B: Medical management1 intervention

Trial outcomes

Primary outcomes

Modified Rankin Scale score

The primary outcome of this study is level of disability assessed by the score on the modified Rankin Scale at 90±14 days (scores range from 0 to 6, with 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death; mRS 6 and 5 will be merged as the worst outcome level to avoid a shift of 6 to 5 to be seen as better outcome).

Time frame

90±14 days after enrollment

Secondary outcomes

Independent ambulation

Score of 0-3 on the modified Rankin scale

Time frame

90±14 days after enrollment

Not ambulatory nor capable of body self-care

Score of 0-4 on the modified Rankin scale

Time frame

90±14 days after enrollment

Functional independence

Score of 0-2 on the modified Rankin scale

Time frame

90±14 days after enrollment

Excellent outcome

Score of 0-1 on the modified Rankin scale

Time frame

90±14 days after enrollment

Other outcomes

Modified Rankin Scale score at 1 year

The score on the Modified Rankin Scale

Time frame

One year after enrollment

Not ambulatory nor capable of body self-care

Score of 0-4 on the modified Rankin scale

Time frame

One year after enrollment

Independent ambulation

Score of 0-3 on the modified Rankin scale

Time frame

One year after enrollment

Functional independence

Score of 0-2 on the modified Rankin scale

Time frame

One year after enrollment

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhongming Qiu

Lead sponsor

Xinqiao Hospital of Chongqing

Sponsor institution

Xiangtan Central Hospital (The Affiliated Hospital of Hunan University)

Collaborator

Source ClinicalTrials.gov

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