Enterprise Stent Implantation in the Treatment of Carotid Artery Stenosis With Ischemic Stroke

NCT02802072 | Completed DMC

• 1 other identifier: BeijingCYH_001
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

To investigate the long-term effects of intracranial implantation of Enterprise stent system versus antiplatelet medication on neurologic deficits, daily living abilities, and carotid artery stenosis in patients with atherosclerotic ischemic stroke.

Conditions

Carotid Artery Stenosis

Outcome Measures

Primary Outcomes (1)

• National Institutes of Health Stroke Scale score

  Patient's neurologic deficits will be evaluated with the National Institutes of Health Stroke Scale (NIHSS) score 1 year after stent implantation or antiplatelet medication or antiplatelet medication only.

  1 year after treatment

Secondary Outcomes (2)

• Changes of Barthel index

  0.5, 1, 2, 3 years after treatment

• Carotid stenosis rate

  1 year after treatment

Study Arms (2)

Enterprise stent implantation group

EXPERIMENTAL

Patients with atherosclerotic ischemic stroke will be randomly allocated to receive Enterprise stent implantation in combination with antiplatelet medication for carotid artery stenosis.

Device: Enterprise stent implantation

Only aspirin medication group

EXPERIMENTAL

Patients with atherosclerotic ischemic stroke will be randomly allocated to receive only antiplatelet medication for carotid artery stenosis.

Drug: Only aspirin medication

Interventions

Enterprise stent implantation DEVICE

Enterprise stent system (Johnson \& Johnson (Shanghai) Medical Equipment Co.,Ltd., China) is a closed loop self-expanding stent system that is made of Ni-Ti alloy. It consists of a self-expanding stent and a delivery system.

Also known as: Enterprise self-expanding stent system implantation

Enterprise stent implantation group

Only aspirin medication DRUG

Only aspirin medication will be conducted, initial dose is 300 mg/d, 200 mg/d 6 months later, and 100 mg/d 1 year later.

Also known as: Drug intervention

Only aspirin medication group

Eligibility Criteria

• Age: 17 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Atherosclerotic plague-caused carotid artery stenosis
• Severe carotid artery stenosis (unilateral stenosis \> 70%) diagnosed according to angiography
• Age 18-75 years
• Of either sex
• Provision of informed consent regarding trial procedure

You may not qualify if:

• Non-atherosclerotic intracranial artery stenosis
• Severe cognitive or mental disorder
• Severe cardiovascular, hepatic, renal, or blood system diseases
• Pregnant or lactating
• Hemorrhagic disease or unable to receive anticoagulation or antiplatelet aggregation treatment
• Allergy to stent material
• Unable to or declined to cooperate with follow-up examination
• Unable to provide informed consent because of intellectual disability or language disorder

Sponsors & Collaborators

• Beijing Chao Yang Hospital: lead

MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Meng Ji, Ph.D.

  Beijing Chao Yang Hospital, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: June 14, 2016
• First Posted: June 16, 2016
• Study Start: January 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: December 1, 2015
• Last Updated: June 16, 2016

Record last verified: 2016-06