AcoArt VI / Vertebral Artery Ostium Stenosis in China

• Sponsor: Acotec Scientific Co., Ltd (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT03910166
• Collaborator: (none)
• Enrollment: 180
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 32.7
• Patients Per Site Per Month: 5.5

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Ischemic Stroke; Transient Ischemic Attack	Procedure: drug-coated balloon catheter（Orchid, Acotec）; Procedure: Intracranial artery stent system（APOLLO）	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 180 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jan 9, 2020
• Anticipated Primary Completion Date: Oct 1, 2022
• Anticipated Study Completion Date: Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DCB group use DEB catheter(trade name:Orchid/Dhalia) to treat the stenosis or occlusion in Vertebral Artery Ostium Stenosis of experimental arm	Procedure: drug-coated balloon catheter（Orchid, Acotec）; After predilation, using drug-coated balloon catheter to cover the whole treated segment
Active Comparator: BMS group use Intracranial artery stent system(trade name:Apollo) to treat stenosis or occlusion in Vertebral Artery Ostium Stenosis of control group	Procedure: Intracranial artery stent system（APOLLO）; stent assisted angioplasty

Outcome Measures

Primary Outcome Measures

1. target lesion restenosis rate [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 Outcome Measures

1. device success rate [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.

2. incidence of hemorrhagic stroke and posterior circulation ischemic stroke [12 Months]

   incidence of hemorrhagic stroke and posterior circulation ischemic stroke within 12 months

3. incidence of transient ischemic attack of posterior circulation [12 Months]

   incidence of transient ischemic attack of posterior circulation within 12 months

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• aged between 18 and 80 years old

• symptomatic VAO stenosis refractory to best medical treatment

• 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 minor stroke

• intracranial stent implantation within 12 months

• Intracranial hemorrhage occurred within 3 months

• Obvious thrombosis in brain vessel, patients received lysis or thrombectomy 24 hours before surgery

• Active bleeding or coagulation disorders

• Serious liver/kidney damage, not suitable for routine surgical treatment

• Patients with severe liver and kidney injury 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Xuanwu hospital	Beijing		China

Sponsors and Collaborators

• Acotec Scientific Co., Ltd

Investigators

• Study Chair: Liqun Jiao, PhD, Xuanwu Hospital, Beijing

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Acotec Scientific Co., Ltd
• ClinicalTrials.gov Identifier: NCT03910166
• Other Study ID Numbers: Acotec-06
• First Posted: Apr 10, 2019
• Last Update Posted: Mar 8, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Acotec Scientific Co., Ltd: drug eluting balloon catheter; stenting
• Additional relevant MeSH terms: Ischemic Stroke; Ischemic Attack, Transient; Ischemia

Study Results

No Results Posted as of Mar 8, 2022