AcoArt VI / Vertebral Artery Ostium Stenosis in China

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-06

Study Completion Date

2023-10-01

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Ischemic Stroke Transient Ischemic Attack

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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DCB group

use DEB catheter(trade name:Orchid/Dhalia) to treat the stenosis or occlusion in Vertebral Artery Ostium Stenosis of experimental arm

Group Type EXPERIMENTAL

drug-coated balloon catheter（Orchid, Acotec）

Intervention Type PROCEDURE

After predilation, using drug-coated balloon catheter to cover the whole treated segment

BMS group

use Intracranial artery stent system(trade name:Apollo) to treat stenosis or occlusion in Vertebral Artery Ostium Stenosis of control group

Group Type ACTIVE_COMPARATOR

Intracranial artery stent system（APOLLO）

Intervention Type PROCEDURE

stent assisted angioplasty

Interventions

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drug-coated balloon catheter（Orchid, Acotec）

After predilation, using drug-coated balloon catheter to cover the whole treated segment

Intervention Type PROCEDURE

Intracranial artery stent system（APOLLO）

stent assisted angioplasty

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No