Actively Recruiting

Phase Not Applicable
Age: 20Years +
All Genders
NCT03179774

Endovascular Revascularization for Chronic Carotid Artery Occlusion Trial

Led by National Taiwan University Hospital · Updated on 2025-07-28

200

Participants Needed

1

Research Sites

445 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Revascularization for carotid artery occlusion (CAO) remained controversial, there is no prospective randomized control trial (RCT) regarding carotid artery stenting (CAS) in CAO patients. The investigators conduct a prospective study composed of clinical registry arm and RCT arm. The main purpose of the study is investigate neurocognitive function at 3 months and thereafter up to 12 months.

CONDITIONS

Official Title

Endovascular Revascularization for Chronic Carotid Artery Occlusion Trial

Who Can Participate

Age: 20Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient age 20 years or older
  • Abnormal cerebral perfusion demonstrated by CT perfusion study or MRI
  • No history of stroke or transient ischemic attack (TIA) on the same side as the carotid occlusion within 90 days before randomization
  • Women must not be of childbearing potential or must have a negative pregnancy test before randomization
  • Modified Rankin Scale score of 2 or less at the time of informed consent (for randomized control study)
  • Only one carotid artery occlusion will be randomized in patients with bilateral occlusion; treatment of the other side must be done at least 30 days before randomization
Not Eligible

You will not qualify if you...

  • Acute stroke within the past 90 days
  • Intolerance or allergic reaction to study medications without suitable alternatives
  • Expected interruption of ADP antagonist therapy within 3 months after procedure
  • Gastrointestinal hemorrhage within 1 month before enrollment that prevents antiplatelet therapy
  • Bleeding disorders or diathesis
  • Intracranial hemorrhage within the past 12 months
  • Platelet count less than 100,000/µl or history of heparin-induced thrombocytopenia
  • High-risk cardiac conditions such as left ventricular aneurysm, severe cardiomyopathy, mechanical heart valves, severe calcific aortic stenosis, endocarditis, moderate to severe mitral stenosis, left atrial thrombus, intracardiac mass, or unrepaired patent foramen ovale with prior paradoxical embolism
  • Major surgery, trauma, or revascularization procedure within the past 1 month
  • Acute coronary syndrome within the past 1 month or not suitable for revascularization
  • Coronary artery disease with multiple severe blockages not treatable by revascularization (randomized control study only)
  • Inability to understand or cooperate with study procedures or provide informed consent
  • Life expectancy less than 5 years
  • Vascular conditions preventing endovascular revascularization
  • Previous ipsilateral carotid artery stenting
  • Intracranial aneurysm or arteriovenous malformation
  • Education level lower than elementary school
  • Aphasia or right-sided hemiparesis
  • Marked depression
  • Severe dementia

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

National Taiwan University Hospital

Taipei, Taiwan, 10002

Actively Recruiting

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Research Team

H

Hsien-Li Kao, MD

CONTACT

Y

Ying-Hsien Chen, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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