Rescue Endovascular Treatment After Neurological Deterioration in Initially Mild Basilar Artery Occlusion in an Extended Time Window

NCT06843356 | Recruiting

• 1 other identifier: RESCUE-BAO
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 2

Brief Summary

A prospective, multicenter, open-label, blinded-endpoint, randomized controlled trial to evaluate whether best medical management (BMM) combined with endovascular therapy (EVT) improves neurological outcomes compared to BMM alone in patients with progressive acute mild ischemic stroke due to basilar artery occlusion within an extended time window.

Conditions

Acute Mild Ischemic Stroke; Basilar Artery Occlusion; Rescue Endovascular Treatment; Extended Time Window

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with a modified Rankin Scale (mRS) score of 0-3 at 90 (±7) days after randomization.

  The modified Rankin Score is an ordinal hierarchical scale ranging from 0 to 6, with higher scores indicating more severe disability.

  90 (±7)days after randomization

Secondary Outcomes (6)

• Shift analysis of the improvement trend in modified Rankin Scale (mRS) scores at 90 (±7) days after randomization.

  90 (±7) days after randomization

• Proportion of patients with a modified Rankin Scale (mRS) score of 0-2 at 90 (±7) days after randomization.

  90 (±7) days after randomization

• Change in NIHSS score from pre-randomization baseline at 24 hours after randomization.

  24 hours after randomization

• EQ-5D-5L scale at 90 (±7) days after randomization.

  90 (±7) days after randomization

• Change in NIHSS score from pre-randomization baseline at 7±1 days after randomization or discharge.

  Discharge or 7±1 days after randomization

Other Outcomes (3)

• Incidence of symptomatic intracerebral haemorrhage (sICH) within 48 hours after randomization (Heidelberg bleeding classification).

  Within 48 hours after randomization.

• Incidence of any intracerebral haemorrhage within 48 hours after randomization (Heidelberg bleeding classification).

  within 48 hours after randomization

• All-cause mortality at 90 (±7) days after randomization.

  90 (±7) days after randomization

Study Arms (2)

Endovascular Therapy Group

EXPERIMENTAL

Researchers can choose to deal with the stenosis or occlusion of blood vessels according to their own judgment, including stent thrombectomy, thrombus aspiration, balloon angioplasty, stent replacement, intra-arterial thrombolysis or various combinations of these methods.

Procedure: Endovascular Treatment

Best Medical Management Group

NO INTERVENTION

Participants receive best medical management only. Best Medical Treatment and maximum supportive care according to local guidelines, not including mechanical thrombectomy, no intra-arterial treatment.

Interventions

Endovascular Treatment PROCEDURE

Neurointerventionist determine whether to proceed with interventional therapy after assessing the location and degree of occlusion, the tortuosity of the access vessel, and the presence of stenosis or occlusion in the proximal artery. In cases where there is no proximal stenosis or occlusion, mechanical thrombectomy is performed, and the specific thrombectomy strategy is tailored by the researcher based on the patient's condition. For lesions associated with proximal vascular stenosis or occlusion, it is necessary to navigate the catheter through the proximal stenosis or occlusion to access the intracranial occlusion. Researchers have the discretion to treat the stenotic or occluded vessels, which may include options such as no treatment, stent thrombectomy, thrombus aspiration, balloon angioplasty, stent replacement, intra-arterial thrombolysis or various combinations of these methods.

Endovascular Therapy Group

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.
• Initially mild ischemic stroke, defined as an initial NIHSS score \<6, with no prior endovascular treatment for the index ischemic event.
• Basilar artery occlusion, or vertebral artery occlusion resulting in complete interruption of antegrade flow into the basilar artery, documented by CTA, MRA, or DSA during the initially mild phase and before qualifying neurological deterioration.
• Qualifying neurological deterioration occurring between 24 hours and 7 days after initial symptom onset, or after the last known well if symptom onset is unknown.
• Qualifying neurological deterioration is defined as an NIHSS score ≥10 with either a ≥4-point increase in total NIHSS or a ≥2-point increase in the NIHSS level-of-consciousness score from the initial NIHSS score and must be documented by certified medical personnel at a medical facility, including a referring hospital.
• Posterior circulation Acute Stroke Prognosis Early CT Score (pc-ASPECTS) ≥6 on noncontrast CT or diffusion-weighted MRI performed after qualifying neurological deterioration.
• Time from qualifying neurological deterioration to randomization ≤24 hours.
• Written informed consent obtained from the patient or a legally authorized representative.

You may not qualify if:

• Symptom progression due to intracranial hemorrhage, brain edema, or other clear causes (including but not limited to infarct hemorrhagic transformation, new infarction in non-occluded vascular regions, obstructive hydrocephalus, severe infection, high fever, heart or kidney dysfunction, hypovolemia, or severe electrolyte disturbances).
• prestroke mRS \>2.
• Factors in the target vessel that are expected to prevent completion of endovascular treatment.
• Concurrent anterior and posterior circulation strokes.
• Prior imaging confirmed or investigator-assessed chronic basilar artery occlusion.
• Presence of untreated intracranial aneurysms, intracranial tumors (except small meningiomas), or intracranial vascular malformations.
• Intracranial hemorrhage within the past 6 months, including parenchymal brain hemorrhage, intraventricular hemorrhage, or subarachnoid hemorrhage.
• Gastrointestinal or urinary tract bleeding, acute myocardial infarction, cranial trauma, or major surgery within the past month.
• Presence of active bleeding, coagulation disorders, or uncorrectable bleeding tendencies.
• Platelet count \<40×10\^9/L, or INR \>2 during anticoagulation therapy (irreversible).
• Severe heart, liver, or kidney dysfunction or other severe systemic late-stage diseases.
• Known allergy to iodine contrast agents or other treatment-related drugs.
• Medically uncontrolled refractory hypertension (defined as persistent systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg) (Note: Participants can be included if their blood pressure is controllable with medication and maintained at an acceptable level).
• Uncontrollable blood glucose \<2.8 mmol/L or \>22.2 mmol/L.
• Pregnancy or breastfeeding.

Sponsors & Collaborators

• First Affiliated Hospital of Wannan Medical College: lead
• The First Affiliated Hospital of the University of Science and Technology of China: collaborator
• First People's Hospital of Yulin: collaborator
• THE SECOND PEOPLE'S HOSPITAL, WUHU: collaborator
• People's Hospital of Guoyang County: collaborator
• Heyuan people's Hospital: collaborator
• The First Affiliated Hospital of Hainan Medical University: collaborator
• Wuwei City People's Hospital: collaborator
• People's Hospital of Lixin Country: collaborator
• Zhongshan Hospital Of Traditional Chinese Medicine: collaborator
• Xihua People's Hospital: collaborator
• Wuhan No.1 Hospital: collaborator
• The Fourth Hospital of Liuan: collaborator
• Huaibei Miner General Hospital, Huaibei, China.: collaborator
• Guangdong Second Provincial General Hospital: collaborator
• The First Affiliated Hospital of University of South China: collaborator
• Maoming Hospital of Traditional Chinese Medicine: collaborator
• People's Hospital of Linquan County: collaborator
• Jiangsu Province Hospital of Traditional Chinese Medicine: collaborator
• Haiyan People's Hospital: collaborator
• Haiyan County People's Hospital: collaborator
• Yingshang County People's Hospital: collaborator
• The second affiliated hospital of Xuzhou medical university: collaborator
• The Central Hospital of Wuhan, Wuhan, Hubei, China: collaborator
• Suixi County Hospital of Traditional Chinese Medicine: collaborator
• Affiliated Jinling Hospital, Medical School of Nanjing University: collaborator
• Xiangtan Central Hospital, Xiangtan, Hunan, China: collaborator
• Feidong County Hospital of Traditional Chinese Medicine, Hefei, Anhui, China: collaborator
• Dongguan People's Hospital, Dongguan, Guangdong, China: collaborator
• The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine: collaborator

Study Sites (2)

The First Affiliated Hospital of the University of Science and Technology of China

Hefei, Anhui, China

RECRUITING

First Affiliated Hospital of Wannan Medical College

Wuhu, Anhui, 241000, China

RECRUITING

Central Study Contacts

Xianjun Huang, PhD

CONTACT

8618130333940; doctorhuangxj@hotmail.com

Wen Sun, PhD

CONTACT

8615050589620; sunwen_medneuro@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

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: February 24, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 16, 2026

Record last verified: 2026-09

Locations

CN (2)