Clinical trial NCT03910166: AcoArt VI / Vertebral Artery Ostium Stenosis in China
Official title: Prospective, Multi-center and Randomized Controlled Clinical Study to Verify Effectiveness and Safety of Drug-eluting Balloon in PTA Procedure of Vertebral Artery Ostium Stenosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Stroke
Transient Ischemic Attack
Keywords: drug eluting balloon catheter
stenting
Lead sponsor: Acotec Scientific Co., Ltd
Sponsor class: INDUSTRY
First posted: 2019-04-10
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether DEB is not inferior to common bare metal stent using under in long-term vessel patency and inhibiting restenosis in Vertebral Artery Ostium Stenosis

Detailed description: Vertebral Artery Origin Stenting is an established alternative to open surgical bypass for the treatment of Vertebral Artery Ostium Stenosis .

DEBs are designed to promote arterial patency by reducing neointimal proliferation.

Eligibility criteria: Inclusion Criteria:

* aged between 18 and 80 years old
* symptomatic VAO stenosis refractory to AMM (aggressive medical management)
* etiology of VAOS was atherosclerosis
* the diameter of the normal segment of the artery beyond the stenosis between 3mm and 5mm
* Target lesion has stenosis ≥ 70% evidenced by angiography
* Score on the modified Rankin scale ≤ 3
* NIHSS≤ 6
* Patients have signed informed consent

Exclusion Criteria:

* In-stent restenosis in vertebral artery
* Severe calcified lesion or residual stenosis ≥30% after predilatation or flow-limiting dissection
* Tortuous or variable vessels
* distal serial stenosis or distal vascular dysplasia of the stenosis segment
* Non-atherosclerotic arterial stenosis
* Non-vertebral artery stenosis caused TIA or stroke
* intracranial stent implantation within 12 months
* Intracranial hemorrhage occurred within 3 months
* Obvious thrombosis in brain vessel, or have received thrombolytic therapy 24 hours before procedure
* Active bleeding or coagulation disorders
* Serious liver/kidney damage, not suitable for routine surgical treatment
* Myocardial infarction or extensive cerebral infarction occurred within 2 weeks
* Uncontrolled high blood pressure
* Complicated intracranial tumor, cerebral arteriovenous malformation, or intracranial aneurysm
* Potential sources of cardiogenic thrombosis, such as mitral stenosis, atrial septal defect, aorta or mitral valve replacement, left atrial myxoma, etc
* Life expectancy shorter than 1 years
* Patients whit cognitive impairment or mental disorders
* Known hypersensitivity to aspirin, heparin, clopidogrel,paclitaxel, contrast medium, etc
* Pregnant and lactating women
* Patients who have participated in other clinical trials during the same period that lead to researchers who believe that patients may not be able to follow the trial program

Primary outcomes:
measure: Rate of target lesion restenosis
timeFrame: 12Months
measure: Rate of device success
timeFrame: during the operation
Secondary outcomes:
measure: Rate of device success
timeFrame: during the operation
measure: Incidence of hemorrhagic stroke and posterior circulation ischemic stroke
timeFrame: 12 Months
measure: Incidence of transient ischemic attack of posterior circulation
timeFrame: 12 Months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu hospital
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Liqun Jiao, PhD
role: STUDY_CHAIR
References:
citation: Wang Y, Ma Y, Gao P, Chen Y, Yang B, Feng Y, Jiao L. Paclitaxel Coated Balloon vs. Bare Metal Stent for Endovascular Treatment of Symptomatic Vertebral Artery Origin Stenosis Patients: Protocol for a Randomized Controlled Trial. Front Neurol. 2021 Jan 18;11:579238. doi: 10.3389/fneur.2020.579238. eCollection 2020.