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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ischemic Stroke
- Sponsor
- Acotec Scientific Co., Ltd
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Rate of device success
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
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
- •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
Outcomes
Primary Outcomes
Rate of device success
Time Frame: during the operation
DEB group: DEB catheter can reach the target lesions, expand as expected (not broken),and withdraw successfully. BES group: the stenosis rate of proximal outflow less than 50% with intervention and no ischemia or hemorrhage occurred.
Rate of target lesion restenosis
Time Frame: 12Months
Target Lesion Restenosis（diameter stenosis ≥50%） under DSA at 12 Months or diamater stenosis ≥50% under DSA before Target Lesion Revascularization within 12 Months
Secondary Outcomes
- Rate of device success(during the operation)
- Incidence of transient ischemic attack of posterior circulation(12 Months)
- Incidence of hemorrhagic stroke and posterior circulation ischemic stroke(12 Months)