Trial of Rescue Endovascular Treatment for Progressive Acute Mild Ischemic Stroke With Basilar Artery Occlusion With Extended Time Window

NCT06843356 | Recruiting

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

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 procedure

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 procedure

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

  90 (±7) days after procedure

• Change in NIHSS score from baseline at 24 hours postoperatively.

  24 hours after procedure

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

  90 (±7) days after procedure

• Change in NIHSS score from baseline at discharge or 5-7 days postoperatively.

  Discharge or 5 -7 days after procedure.

Other Outcomes (3)

• Incidence of symptomatic intracerebral haemorrhage (sICH) within 24 (±6) hours after randomization (Heidelberg bleeding classification).

  Within 24 (±6) hours after procedure

• Incidence of any intracerebral haemorrhage within 24 (±6) hours after randomization (Heidelberg bleeding classification).

  within 24 (±6) hours after procedure

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

  90 (±7) days after procedure

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.
• Symptoms and signs consistent with basilar artery ischemia.
• Basilar artery or vertebral artery occlusion confirmed by computed tomography angiography (CTA), magnetic resonance angiography (MRA), or digital subtraction angiography (DSA); if vertebral artery occlusion is present, it should completely block blood flow along the basilar artery.
• First-time onset meeting the criteria for mild ischemic stroke diagnosis: NIHSS score \<6.
• Symptom progression within 7 days of the first onset.
• Symptom progression: NIHSS score increase ≥4 points or consciousness level increase ≥2 points from the initial NIHSS score.
• Time from symptom onset to randomization \>24 hours.
• Symptom progression to randomization time ≤24 hours.
• NIHSS score ≥10 before randomization.
• pc-ASPECTS before randomization ≥ 6
• The patient or their family members are willing to comply with the protocol requirements and data collection procedures, understand, and sign the informed consent form.

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, severe infection, high fever, heart or kidney dysfunction, hypovolemia, or severe electrolyte disturbances).
• mRS \>2.
• Factors in the target vessel that are expected to prevent completion of endovascular treatment.
• Multiple vessel occlusions.
• 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

Study Sites (1)

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: DOUBLE
• Who Masked: CARE PROVIDER, 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: June 1, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 15, 2025

Record last verified: 2025-04

Locations

CN (1)