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

NCT06881420 | Recruiting DMC

• 1 other identifier: FujianUnionHospital
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

This study will explore the safety and efficacy of BASIS technology in ICAS-LVO lesions through a multicenter, prospective, registry, observational single-arm study.By registering intraoperative recanalization using this technique time, recanalization grade, operative thrombectomy times, intraoperative complications perforating branch occlusion, vascular dissection, vascular rupture, Ectopic thrombus, probability of symptomatic intracranial hemorrhage, mRS Score and mortality rate were followed up for 3 months The unique advantages of the application of the assessment BASIS in this type of lesion provide new insights into complex lesions such as ICAS-LVO The thought and operation method can shorten the operation time, improve the good prognosis, reduce the economic burden and reduce the operation Complications make a positive contribution to ensure that patients receive safe, effective and precise treatment.

Conditions

Acute Ischemic Stroke; ICAS - Intracranial Atherosclerosis

Keywords

Acute Ischemic Stroke; ICAS - Intracranial Atherosclerosis; Endovascular thrombectomy; BASIS

Outcome Measures

Primary Outcomes (2)

• mRS scores at 90 days

  functional recovery, assessed by change in modified Rankin Scale (mRS) scores (ranging from 0 \[no symptoms\] to 6 \[death\]) at 90 days after onset

  90 days

• FPE:first pass effect

  Vascular revascularization rate by basis technique at the first attempt

  From enrollment to the end of the surgery about 3 hours

Secondary Outcomes (1)

• Residual stenosis rate of target vessel

  From enrollment to the end of the surgery about 3 hours

Study Arms (1)

using BASIS technique

Procedure: BASIS technique

Interventions

BASIS technique PROCEDURE

Balloon AngioplaSty with the dIstal protection of Stent retriever

using BASIS technique

Eligibility Criteria

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

Study Population

ICAS-LAO stroke

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fujian Medical University Union Hospital: lead
• Zhangzhou Municipal Hospital of Fujian Province: collaborator
• First Affiliated Hospital of Jinan University: collaborator

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Intracranial Arteriosclerosis

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Arterial Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2025
• First Posted: March 18, 2025
• Study Start: January 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 18, 2025

Record last verified: 2025-01

Locations

CN (1)