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Completed

NCT Number: NCT03910166

AcoArt VI / Vertebral Artery Ostium Stenosis in China

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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Key information

Conditions

Ischemic Stroke Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Attack, Transient Nervous System Diseases Stroke Transient Ischemic Attack Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xuanwu hospital

Beijing, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

drug-coated balloon catheter（Orchid, Acotec）

Procedure

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

Intracranial artery stent system（APOLLO）

Procedure

stent assisted angioplasty

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. 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.

  2. Incidence of hemorrhagic stroke and posterior circulation ischemic stroke

    Time frame: 12 Months

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

  3. Incidence of transient ischemic attack of posterior circulation

    Time frame: 12 Months

    incidence of transient ischemic attack of posterior circulation within 12 months

Sponsors and collaborators

Lead sponsor

Acotec Scientific Co., Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Apr 10, 2019
Registry last updated
Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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