Acute Ischemic StrokeNCT06881420
BASIS Technique for Endovascular Therapy of Acute Large Vessel Occlusion Strokes Due to Intracranial Atherosclerotic Disease
An observational study of Acute Ischemic Stroke and ICAS - Intracranial Atherosclerosis, run by Fujian Medical University Union Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke, ICAS - Intracranial Atherosclerosis
- What is being tested?
- BASIS technique
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Dec 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ICAS-LAO stroke
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian
Chen wenhuo, master, 13806906089, 13806906089@126.com
About this study
Official title: 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.
Read the 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.
- 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.
- Use the anchoring effect of the thrombectomy bracket to pull the microcatheter out of the body.
- 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.
- 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.
- Remove the balloon to enlarge the suction cavity and remove the thrombus using SWIM technique.
- 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
- Being tested
- BASIS technique
- Keywords
- Acute Ischemic Stroke, ICAS - Intracranial Atherosclerosis, Endovascular thrombectomy, BASIS
- Medical subject headings
- Ischemic Stroke, Intracranial Arteriosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BASIS techniqueProcedure or surgery
Balloon AngioplaSty with the dIstal protection of Stent retriever
| Study group | Role | What they receive |
|---|---|---|
| using BASIS technique | Not described Receives: Procedure: BASIS technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 90 days
FPE:first pass effect
Vascular revascularization rate by basis technique at the first attempt
Measured: From enrollment to the end of the surgery about 3 hours
Secondary outcomes (1)
Residual stenosis rate of target vessel
Measured: From enrollment to the end of the surgery about 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start1 Jan 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zhangzhou Municipal Hospital of Fujian Province, First Affiliated Hospital of Jinan University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06881420
- Sponsor's protocol ID
- FujianUnionHospital
- Status last verified
- Aug 2026
- First submitted
- 19 Jan 2025
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided