Endovascular Revascularization for Chronic Carotid Artery Occlusion Trial

NCT03179774 | Recruiting DMC

• 1 other identifier: 201702049RINA
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Carotid Occlusion

Outcome Measures

Primary Outcomes (5)

• NCF improvement by Alzheimer Disease Assessment Scale-Cognitive subscale (ADAS-Cog)

  Neurocognitive function was evaluated by ADAS-Cog

  at 3 months and thereafter up to 12 months

• NCF improvement by Mini-Mental State Examination (MMSE)

  Neurocognitive function was evaluated by MMSE.

  at 3 months and thereafter up to 12 months

• NCF improvement by verbal fluency test

  Neurocognitive function was evaluated verbal fluency test

  at 3 months and thereafter up to 12 months

• NCF improvement by verbal fluency test Color Trails Test Parts 1

  Neurocognitive function was evaluated by Color Trails Test Parts 1

  at 3 months and thereafter up to 12 months

• NCF improvement by verbal fluency test Color Trails Test Parts 2

  Neurocognitive function was evaluated by Color Trails Test Parts 2

  at 3 months and thereafter up to 12 months

Secondary Outcomes (7)

• Death and stroke

  within 30 days after the procedure and between 31 days and 1 year

• Major stroke, ischemic stroke, or hemorrhagic stroke

  within 30 days after the procedure and between 31 days and 1 year

• Cambridge Neuropsychological Test Automated Battery (CANTAB)

  at 3 months and thereafter up to 12 months

• Change of cerebral perfusion

  at 3 months and thereafter up to 12 months

• Target vessel revascularization rate

  one year

Other Outcomes (2)

• Major procedure complication

  30 days

• Bleeding complication

  one year

Study Arms (4)

Clinical registry-ER and OMT

EXPERIMENTAL

In clinical registry setting, participants who selected Endovascular revascularization and optimal medical therapy as the treatment for carotid artery occlusion are enrolled.

Device: Endovascular revascularization

Clinical registry-OMT

NO INTERVENTION

In clinical registry setting, participants who selected optimal medical therapy as the treatment for carotid artery occlusion are enrolled.

RCT-ER and OMT

EXPERIMENTAL

In randomized control trial setting, participants who are randomized to received endovascular revascularization and optimal medical therapy for carotid artery occlusion are enrolled.

Device: Endovascular revascularization

RCT-OMT

NO INTERVENTION

In randomized control trial setting, participants who are randomized to received optimal medical therapy for carotid artery occlusion are enrolled.

Interventions

Endovascular revascularization DEVICE

All interventions will be performed via 8F femoral sheath. Target common carotid artery will be engaged with 8F JR 4 guiding catheter. Intra-luminal wiring using coronary guidewires and microcatheters or alternative subintimal tracking with antegrade re-entry technique. Wiring would be abandoned after 30 minutes of futile effort, consumption of more than 300 ml of contrast, or when the wire tip is confirmed to be extravascular. Once wire enters distal true lumen, the microcatheter was exchanged to a 1.5 mm diameter coronary balloon for pre-dilatation. Distal embolic protection device would be deployed if an adequate landing zone can be identified. Properly sized balloon expandable stents and self-expanding stents were then deployed to scaffold the occlusion. Balloon post-dilatation may be done if stent expansion was inadequate.

Also known as: Carotid artery stenting

Clinical registry-ER and OMT; RCT-ER and OMT

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient age 20 years or older
• Abnormal cerebral perfusion by CTP or MRI
• No medical history of stroke or transient ischemic attack (TIA) ipsilateral to the carotid occlusion within 90 days of randomization
• Women must not be of childbearing potential or, if of childbearing potential, have a negative pregnancy test prior to randomization.

You may not qualify if:

• Patient has acute stroke within 90 days,
• Intolerance or allergic reaction to a study medication without a suitable management alternative.
• Patient is expected to have the ADP antagonist therapy interruption within 3 months after the procedure.
• GI hemorrhage within 1 month prior to enrollment that would preclude antiplatelet therapy
• Bleeding diathesis
• Intracranial hemorrhage within the past 12 months.
• Platelet count \<100,000/μl or history of heparin-induced thrombocytopenia.
• Other high-risk cardiac sources of emboli, including left ventricular aneurysm, severe cardiomyopathy, aortic or mitral mechanical heart valve, severe calcific aortic stenosis (valve area \< 1.0 cm2), endocarditis, moderate to severe mitral stenosis, left atrial thrombus, or any intracardiac mass, or known unrepaired patent foramen ovale (PFO) with prior paradoxical embolism.
• Any major surgery, major trauma, revascularization procedure within the past 1 month.
• Acute coronary syndrome within the past 1 month or acute coronary syndrome (ACS) that is not amenable to revascularization (patients should undergo planned coronary revascularization at least 30 days before randomization).
• Inability to understand and cooperate with study procedures or provide informed consent.
• Patients with \< 5 years life expectancy
• Concomitant vascular conditions precluding endovascular revascularization procedure;
• Previous ipsilateral carotid artery stenting
• Intracranial aneurysm or arteriovenous malformation;

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 10002, Taiwan

RECRUITING

Study Officials

• Hsien-Li Kao, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hsien-Li Kao, MD

CONTACT

+886-2-2312-3456; hsienli_kao@yahoo.com

Ying-Hsien Chen, MD

CONTACT

+886-972652463; indiglo314@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Part 1: Clinical registry study (Optimal medical therapy group vs. Endovascular revascularization and optimal medical therapy) Part 2: Randomized control trial (Optimal medical therapy group vs. Endovascular revascularization and optimal medical therapy)

Study Record Dates

• First Submitted: May 28, 2017
• First Posted: June 7, 2017
• Study Start: May 17, 2017
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)