AcoArt VI / Vertebral Artery Ostium Stenosis in China

Ischemic Stroke Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03910166
• Other study ID #: Acotec-06
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 6, 2020
• Est. completion date: March 1, 2024

Study information

• Verified date: January 2024
• Source: Acotec Scientific Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 180
• Est. completion date: March 1, 2024
• Est. primary completion date: July 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Ischemia
• Ischemic Attack, Transient
• Ischemic Stroke
• Transient Ischemic Attack

Intervention

Procedure:
• drug-coated balloon catheter(Orchid, Acotec)
After predilation, using drug-coated balloon catheter to cover the whole treated segment
• Intracranial artery stent system(APOLLO)
stent assisted angioplasty

Locations

Country	Name	City	State
China	Xuanwu hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Acotec Scientific Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of target lesion restenosis	Target Lesion Restenosis(diameter stenosis =50%) under DSA at 12 Months or diamater stenosis =50% under DSA before Target Lesion Revascularization within 12 Months	12Months
Primary	Rate of device success	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.	during the operation
Secondary	Rate of device success	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.	during the operation
Secondary	Incidence of hemorrhagic stroke and posterior circulation ischemic stroke	incidence of hemorrhagic stroke and posterior circulation ischemic stroke within 12 months	12 Months
Secondary	Incidence of transient ischemic attack of posterior circulation	incidence of transient ischemic attack of posterior circulation within 12 months	12 Months