Triage of Patients Presenting Beyond 24 Hours With Ischemic Stroke Due to Vertebrobasilar Artery Occlusion

NCT06510634 | Enrolling By Invitation DMC

• 1 other identifier: TJHH-2024-WM51
• Study Type: observational
• Target: 236
• Locations: 1 country
• Sites: 1

Brief Summary

Endovascular thrombectomy (EVT) for posterior circulation occlusion is generally performed within a window of less than 24 hours from the time the patient was last known well (LKW). The efficacy and safety of EVT beyond the 24-hour window remain uncertain.

Conditions

Stroke, Ischemic

Outcome Measures

Primary Outcomes (1)

• proportion of patients with Modified ranking scale (mRS) (0-3) at 90 days

  A 0-6 scale running from perfect health without symptoms to death.

  90(±14)days

Secondary Outcomes (3)

• distribution of patients with Modified ranking scale (mRS) (0-3) at 90 days

  90(±14)days

• Mortality within 90 days

  90(±14)days

• Incidence of symptomatic intracranial haemorrhage

  90(±14)days

Study Arms (2)

endovascular thrombectomy group

The EVT group would include Stent retriever thrombectomy; Aspiration; Balloon angioplasty and/or stenting; Intra-arterial medication; Combination

Other: Endovascular Therapy

best medical treatment gruop

BMM consisted of IVT antiplatelet drugs, anticoagulation, or combinations of these treatment modalities according to institutional guidelines.

Other: Endovascular Therapy

Interventions

Endovascular Therapy OTHER

Endovascular therapy, as an adjunct to standard stroke therapy, may be beneficial for a very select population of patients who present with an acute ischemic stroke and have a proven large, proximal occlusion on imaging. Endovascular therapy includes any one or more of the following: Intra-arterial thrombolytic therapy, aspiration, stent retrieval, or a combination of multiple mechanical devices.

best medical treatment gruop; endovascular thrombectomy group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study is a prospective, multicenter cohort study, which analyzed the prospectively databases of 11 stroke centers.Including patients with ischemic stroke due to vertebrobasilar artery beyond 24 hours from last known well.

You may qualify if:

• age≥18 years.;
• blockage in the vertebrobasilar artery, including the vertebral artery or basilar artery, determined using computed tomographic angiography (CTA)/ magnetic resonance angiography (MRA)/digital subtraction angiography (DSA);
• VBAO occurrence more than 24 hours from LKW;
• none to mild premorbid disability defined by modified Rankin Scale (mRS) score ≤2;
• informed consent before enrollment in the clinical trials.

You may not qualify if:

• neuroimaging evidence of cerebral hemorrhage on presentation;
• lack of follow up information on outcomes at 90 days
• serious, advanced, or terminal illness.

Sponsors & Collaborators

• Tianjin Huanhu Hospital: lead

Study Sites (1)

Tianjin Huanhu Hospital

Tianjin, Tianjin Municipality, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: July 14, 2024
• First Posted: July 19, 2024
• Study Start: June 1, 2019
• Primary Completion: April 1, 2024
• Study Completion (Estimated): March 1, 2028
• Last Updated: February 28, 2025

Record last verified: 2025-02

Locations

CN (1)