Endovascular Treatment for eXtra-Large Ischemic Stroke

NCT06388148 | Recruiting DMC

• 1 other identifier: XL STROKE-2
• Study Type: interventional
• Target: 286
• Locations: 1 country
• Sites: 2

Brief Summary

The role of endovascular thrombectomy in patients with extra-large ischemic burden is still unclear. The XL STROKE-2 randomized trial is aiming to investigate the efficacy and safety of mechanical thrombectomy in acute extra-large ischemic stroke patients with large vessel occlusion.

Conditions

Stroke, Acute Ischemic

Outcome Measures

Primary Outcomes (1)

• Modified Rankin Scale score

  Modified Rankin scale score (mRS): 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

  90 days after randomization

Secondary Outcomes (4)

• Rate of successful reperfusion

  Within 5 minutes at the end of angiogram

• Rate of excellent outcome

  90 days after randomization

• Rate of functional independence

  90 days after randomization

• Rate of independent ambulation

  90 days after randomization

Study Arms (2)

Endovascular thrombectomy

EXPERIMENTAL

Patients in this group will be treated with medical management plus endovascular thrombectomy

Drug: Medical management; Procedure: Endovascular thrombectomy

Medical management

ACTIVE COMPARATOR

Patients in this group will be treated with medical management alone

Drug: Medical management

Interventions

Medical management DRUG

Medical management includes IV thrombolysis, antiplatelet, and/or anticoagulation.

Endovascular thrombectomy; Medical management

Endovascular thrombectomy PROCEDURE

Endovascular thrombectomy with stent-retriever, local aspiration, angioplasty, and/or stenting.

Endovascular thrombectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older, and modified Rankin scale score = 0 or 1 in patients 80 years or older;
• Acute ischemic stroke within 6 hours from last known well to randomization, or with negative MRI-FLAIR (no change on FLAIR sequence and presence of infarct on MRI-DWI) if \> 6 hours or unknown last known well time;
• Occlusion of the internal carotid artery, M1 or M2 segment of the middle cerebral artery confirmed by CTA/MRA/DSA;
• Baseline ASPECTS score of 0-2 or infarct core volume ≥100ml;
• The patient or patient's representative signs a written informed consent form.

You may not qualify if:

• CT or MR evidence of hemorrhage;
• Evidence of mass effect with ventricular effacement, midline shift or herniation on baseline imaging;
• Vessel tortuosity where it is expected that the thrombectomy device will not be able to reach the occlusion site or result in unstable access;
• History of bleeding disorders, severe heart, liver or kidney disease, or sepsis;
• Currently participating in another investigational drug study;
• Any terminal illness with life expectancy less than 6 months.

Sponsors & Collaborators

• Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University: collaborator
• Longyan First Affiliated Hospital of Fujian Medical University: collaborator
• Taizhou First People's Hospital: collaborator
• Zhangzhou Affiliated Hospital of Fujian Medical University: collaborator
• The First Affiliated Hospital, University of South China: collaborator
• Zhongming Qiu: lead
• Xiangtan Central Hospital: collaborator

Study Sites (2)

The First Affiliated Hospital, Hengyang Medical School, University of South China

Hengyang, Hunan, China

RECRUITING

Xiangtan Central Hospital

Xiangtan, Hunan, 421001, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Practice Management, Medical

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Practice Management; Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• Guangxiong Yuan

  Xiangtan Central Hospital

  PRINCIPAL INVESTIGATOR

• Congguo Yin

  Hangzhou First Hospital of Zhejiang University

  PRINCIPAL INVESTIGATOR

• Tingyu Yi

  Zhangzhou Affiliated Hospital of Fujian Medical University

  PRINCIPAL INVESTIGATOR

• Chong Zheng

  Longyan First Hospital of Fujian Medical University

  PRINCIPAL INVESTIGATOR

• Chenghua Xu

  Taizhou First People's Hospital

  PRINCIPAL INVESTIGATOR

• Zhongfan Ruan

  The First Affiliated Hospital, Hengyang Medical School, University of South China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhongfan Ruan

CONTACT

15616320002; ruanzhongfan@sina.com

Zhongming Qiu

CONTACT

13236599269; qiuzhongmingdoctor@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 21, 2024
• First Posted: April 29, 2024
• Study Start: June 16, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Two years after the trial results are revealed.
• Access Criteria: After approval of a proposal from principal investigator

Locations

CN (2)