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AcoArt VI / Vertebral Artery Ostium Stenosis in China

Primary Purpose

Ischemic Stroke, Transient Ischemic Attack

Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
drug-coated balloon catheter（Orchid, Acotec）
Intracranial artery stent system（APOLLO）
Sponsored by
Acotec Scientific Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring drug eluting balloon catheter, stenting

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Xuanwu hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DCB group

BMS group

Arm Description

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

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

Outcomes

Primary Outcome Measures

target lesion restenosis rate
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

device success rate
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.
incidence of hemorrhagic stroke and posterior circulation ischemic stroke
incidence of hemorrhagic stroke and posterior circulation ischemic stroke within 12 months
incidence of transient ischemic attack of posterior circulation
incidence of transient ischemic attack of posterior circulation within 12 months

Full Information

First Posted
April 9, 2019
Last Updated
October 19, 2023
Sponsor
Acotec Scientific Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT03910166
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 6, 2020 (Actual)
Primary Completion Date
July 6, 2023 (Actual)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acotec Scientific Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke, Transient Ischemic Attack
Keywords
drug eluting balloon catheter, stenting

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DCB group
Arm Type
Experimental
Arm Description
use DEB catheter(trade name:Orchid/Dhalia) to treat the stenosis or occlusion in Vertebral Artery Ostium Stenosis of experimental arm
Arm Title
BMS group
Arm Type
Active Comparator
Arm Description
use Intracranial artery stent system(trade name:Apollo) to treat stenosis or occlusion in Vertebral Artery Ostium Stenosis of control group
Intervention Type
Procedure
Intervention Name(s)
drug-coated balloon catheter（Orchid, Acotec）
Intervention Description
After predilation, using drug-coated balloon catheter to cover the whole treated segment
Intervention Type
Procedure
Intervention Name(s)
Intracranial artery stent system（APOLLO）
Intervention Description
stent assisted angioplasty
Primary Outcome Measure Information:
Title
target lesion restenosis rate
Description
Target Lesion Restenosis（diameter stenosis ≥50%） under DSA at 12 Months or diamater stenosis ≥50% under DSA before Target Lesion Revascularization within 12 Months
Time Frame
12Months
Secondary Outcome Measure Information:
Title
device success rate
Description
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.
Time Frame
during the operation
Title
incidence of hemorrhagic stroke and posterior circulation ischemic stroke
Description
incidence of hemorrhagic stroke and posterior circulation ischemic stroke within 12 months
Time Frame
12 Months
Title
incidence of transient ischemic attack of posterior circulation
Description
incidence of transient ischemic attack of posterior circulation within 12 months
Time Frame
12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liqun Jiao, PhD
Organizational Affiliation
Xuanwu Hospital, Beijing
Official's Role
Study Chair
Facility Information:
Facility Name
Xuanwu hospital
City
Beijing
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
33584491
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.
Results Reference
derived

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AcoArt VI / Vertebral Artery Ostium Stenosis in China

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