Using BASIS technique for treating acute large vessel occlusion strokes

A Prospective Multicenter Registry Study on BASIS Technique for Endovascular Therapy of Acute Large Vessel Occlusion Strokes Due to Intracranial Atherosclerotic Disease (BASIS-DUO)

This study is testing a new method called BASIS to see if it can safely help people with severe strokes caused by blocked blood vessels in the brain recover better.

Quick facts

• Study type: Observational
• Enrollment: 250 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fujian Medical University Union Hospital (other)
• Locations: 1 site (Fuzhou, Fujian)
• Trial ID: NCT06881420 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the safety and efficacy of the BASIS technique for endovascular therapy in patients with acute ischemic strokes caused by intracranial atherosclerotic disease. It involves a multicenter, prospective registry where patients will be treated using the BASIS method, which combines balloon angioplasty with distal protection from a stent retriever. The study will track various outcomes, including recanalization success, complications, and patient recovery over a three-month follow-up period. By focusing on complex lesions, this approach seeks to improve treatment outcomes and reduce complications.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who have experienced an ischemic stroke within 72 hours and have neuroimaging indicating large vessel occlusion.

Not a fit: Patients with multiple vessel occlusions, hemorrhagic strokes, or contraindications to antiplatelet therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to safer and more effective treatment options for patients suffering from acute ischemic strokes.

How similar studies have performed: While the BASIS technique is a novel approach, similar endovascular techniques have shown promise in treating acute strokes, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

* Age ≥18 years old;
* Ischemic stroke;
* Within 72 hours from the onset of symptoms to the time of visit, including post-awakening stroke or blindness For stroke patients, the time when symptoms start is defined as "the last normal time";
* Neuroimaging examination indicated occlusion of anterior or posterior intracranial large vessels, TOAST type was large atherosclerosis type.
* BASIS technique was used for intravascular therapy.

Exclusion Criteria:

* Neuroimaging findings on admission, acute occlusion of multiple vessels and tandem lesions;
* History of atrial fibrillation or heart valve surgery;
* There are clinical contraindications to the use of antiplatelet drugs (hemophilia or thrombocytopenia).Rare disease, known history of coagulation disorders, platelet abnormalities; There is active internal bleeding, intracranial Bleeding history, arteriovenous malformation, aneurysm, etc.);
* Other types of stroke, including hemorrhagic stroke.

Where this trial is running

Fuzhou, Fujian

• Fujian Medical University Union Hospital — Fuzhou, Fujian, China (RECRUITING)

Conditions: Acute Ischemic Stroke, ICAS - Intracranial Atherosclerosis, Endovascular thrombectomy, BASIS