Randomized Controlled Trial of Endovascular Therapy for Acute Large Vessel Occlusion With Large Ischemic Core

Mechanical Thrombectomy Clinical Trial

Official title:

Randomized Controlled Trial of Endovascular Therapy for Acute Large Vessel Occlusion With Large Ischemic Core (RESCUE Japan LIMIT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03702413
• Other study ID #: R000038184
• Status: Completed
• Phase: N/A
• Start date: November 30, 2018
• Est. completion date: March 30, 2022

Study information

• Verified date: July 2022
• Source: Hyogo College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

RESCUE-Japan LIMIT(Recovery by Endovascular Salvage for Cerebral Ultra-acute Embolism Japan Large IscheMIc core Trial) is a prospective, open label, blinded endpoint (PROBE), Japanese, two-arm, randomized, controlled, post-market study to compare the effectiveness of endovascular treatment as compared to best medical treatment alone in the acute ischemic stroke patients with an low ASPECTS (CT-ASPECTS 3-5 or DWI-ASPECTS 3-5).

The purpose of this study is to investigate the efficacy of endovascular treatment for acute large vessel occlusion with large ischemic core (CT-ASPECT score 3-5 or DWI-ASPECT score 3-5).

Description:

In the American Heart Association guideline 2018, endovascular therapy (EVT) has been strongly recommended as class of recommendation (COR) I for for the patients with acute cerebral large vessel occlusion (LVO), the Alberta Stroke Program Early CT Score (ASPECTS) 6 or more. The efficacy of EVT for the patients with low ASPECTS remains unclear.

This study is a prospective, open label, blinded endpoint (PROBE), Japanese, two-arm, randomized, controlled, post-market study to compare the effectiveness of endovascular treatment as compared to best medical treatment alone for acute large vessel occlusion patients with large ischemic core (ASPECTS 3-5 or DWI-ASPECTS 3-5).

Up to 200 subjects will be enrolled in the study and randomized for the Intention to treat analysis set. The randomization will be stratified by treatment institutes, patient's age (less than 75 years old or not), time from symptom onset (0-2 hours or more than 2 hours), and stroke severity (NIHSS 21 or more/less than 21), and administration of rt-PA.

Subjects who meet the inclusion criteria will be randomized in a 1:1 ratio to one of the following two treatment arms: Arm 1: best medical treatment Arm 2: best medical treatment plus endovascular treatment

Primary outcome of this study is to investigate efficacy of endivascular treatment in acute stroke patients with large ischemic core (ASPECTS 3-5 or DWI-ASPECTs 3-5) as compared to best medical treatment alone.

Approximately 40 sites in Japan Patients presenting with acute ischemic stroke (AIS) based on focal occlusion in the M1 segment of the middle cerebral artery (MCA), and/or the intracranial segment of the distal internal carotid artery (ICA), determined by Magnetic Resonance Angiography (MRA) or Computed Tomographic Angiography (CTA), and who meet all eligibility criteria will be considered for study enrollment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: March 30, 2022
• Est. primary completion date: December 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Acute cerebral infarction

2. Age = 18

3. NIHSS = 6

4. Prestroke Modified Rankin Score 0-1

5. ICA or M1 Occlusion on CT angiography or MR angiography

6. ASPECTS 3-5 or DWI-ASPECTS 3-5

7. Randamization can be finished within 6 hours from last known well time, or 6 to 24 hours from last well known well time without positive lesion on MRI-FLAIR image.

8. Endovascular treatment can be initiatedwithin 60 minutes from randomization

9. Patient or Legally Authorized Representative has signed the Informed Consent form

Exclusion Criteria:

1. Significant mass effect with midline shift

2. Known allergy to contrast agents

3. Evidence of acute intracranial hemorrhage

4. Female who is pregnant or suspicision of pregnant

5. Clinical evidence of chronic occlusion

6. High risk of hemorrhage (platelet < 40,000 /µL, APTT > 50 second or PT-INR > 3.0)

7. Participating in any other therapeutic investigational trial

8. Subjects who, in the judgment of the investigator, are likely to be non-compliant or uncooperative during the study.

Related Conditions & MeSH terms

• Ischemia
• Large Ischemic Core
• Mechanical Thrombectomy

Intervention

Procedure:
• Endovascular treatment
Acute thrombectomy

Locations

Country	Name	City	State
Japan	Hyogo collage of Medicine	Nishinomiya	Hyogo

Sponsors (1)

Lead Sponsor	Collaborator
Hyogo College of Medicine

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	modified Rankin Scale =3 at 90 days	The primary endpoint of the trial is the modified Rankin Scale (mRS) =3 at 90 days post-stroke.The scale runs from 0-6 with 0 being perfect health without symptoms to 6 being death.; 0: No symptoms.; No significant disability. Able to carry out all usual activities, despite some symptoms.; Slight disability. Able to look after own a?airs 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 a?ention, bedridden, incontinent.; Dead.	90 days
Secondary	modified Rankin Scale=2 at 90 days	Functional independence as difined by modified Rankin ScalemRS=2 at 90 days	90 days
Secondary	modified Rankin Scale=1 at 90 days	Excellent outcome as difined by modified Rankin Scale=1 at 90 days	90 days
Secondary	Distribution of patients across the ordinal modified Rankin scale	The difference in linear trends in ordinal mRS outcomes between treatment groups (mRS shift analysis)	90 days
Secondary	NIHSS improvement 8 points or more at 48 hours	Early improvement of neulogical findings	48 hours
Secondary	Symptomatic intracranial hemorrhage within 48 hours	Defined as NIHSS worsening of 4 or more points associated with ICH within 48 hours of randomization	48 hours
Secondary	Intracranial hemorrhage within 48 hours	The incidence of hemorrhage	48 hours
Secondary	Death	Death due to any cause at 90 days	90 days
Secondary	Recurrence of cerebral infarction within 90 days	Recurrence of cerebral infarction	90 days
Secondary	Propotion of subjects who required decompressive craniectomy within 7 days	Propotion of subjects who had space-occupying infarction (malignant brain edema) and requred decompressive craniectomy within 7 days	7 days