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

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 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.

Study Overview

• Status: Recruiting
• Conditions: Acute Ischemic Stroke; ICAS - Intracranial Atherosclerosis
• Intervention / Treatment: Procedure: BASIS technique

Detailed Description

This project intends to set up a prospective multi-center single-arm study with no control group and no upper limit of cases.

Using BASIS (Balloon AngioplaSty with the dIstal protection of Stent retriever) technique .

- Balloon angioplasty under the protection of the remote thrombectomy stent for intravascular treatment, such as the BASIS technique for thrombectomy loss Failure, the surgeon can take different techniques for remedial treatment.

1. Construct the three-axis system and establish the path. The microcatheter passes 15mm through the distal end of the thrombus Above, after the thrombectomy stent covering the narrow segment was released, angiography was performed to observe the stenosis and distal thrombus.
2. Use the anchoring effect of the thrombectomy bracket to pull the microcatheter out of the body.
3. Send the guide wire along the thrombectomy stent to the balloon expansion catheter, and place the balloon in the narrow section. At this time, follow the blood The position of the plug relative to the stenosis determines whether to semi-retrieve the Syphonet® plug holder, fill the balloon for expansion, Balloon pressure relief.

4. Use the distal end of the thrombectomy stent to anchor and the support of the balloon dilating catheter to advance the thrombectomy catheter.

   Until the end of the thrombus suction catheter reaches the narrow site.

5. Remove the balloon to enlarge the suction cavity and remove the thrombus using SWIM technique.
6. The residual thrombus was cleaned up and the thrombectomy stent was released again. The thrombectomy stent was recovered after angiographic observation: assembled in vitro With the microcatheter, the thrombectomy stent was released again via the microcatheter. Angiography was performed to observe the treatment of thrombus and stenosis Avoid thrombus escape due to direct hand angiography, if there is still thrombus, continue mechanical thrombus removal until the thrombus is cleared After the microcatheter was recovered and the thrombectomy scaffold was withdrawn, the micro

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China
      • Recruiting
      • Fujian Medical University Union Hospital
      • Contact: Chen wenhuo, master; Phone Number: 13806906089; Email: 13806906089@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

ICAS-LAO stroke

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
using BASIS technique	Procedure: BASIS technique; Balloon AngioplaSty with the dIstal protection of Stent retriever

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Residual stenosis rate of target vessel	From enrollment to the end of the surgery about 3 hours

Collaborators and Investigators

• Sponsor: Fujian Medical University Union Hospital
• Collaborators: First Affiliated Hospital of Jinan University; Zhangzhou Municipal Hospital of Fujian Province

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: January 19, 2025
• First Submitted That Met QC Criteria: March 11, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Acute Ischemic Stroke; Endovascular thrombectomy; BASIS; ICAS - Intracranial Atherosclerosis
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Intracranial Arterial Diseases; Ischemic Stroke; Stroke; Intracranial Arteriosclerosis; Atherosclerosis
• Other Study ID Numbers: FujianUnionHospital

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No