Smart Nitinol Stent System for the Treatment of Severe Atherosclerotic Carotid Stenosis

NCT02800174 | Completed DMC

• 1 other identifier: BeijingJH_001
• Study Type: interventional
• Target: 103
• Locations: 0 countries
• Sites: N/A

Brief Summary

To validate the long-term effects of implantation of the self-expanding Smart nitinol stent system for the treatment of severe atherosclerotic carotid stenosis in a 2-year follow-up study of a large patient cohort

Conditions

Carotid Artery Stenosis

Outcome Measures

Primary Outcomes (1)

• mRS score

  The mRS is a 7-point scale used to evaluate a patient's functional recovery.

  2 years after treatment

Secondary Outcomes (2)

• The recurrence of cerebrovascular events

  1 and 2 years after treatment

• National Institute of Health stroke scale(NIHSS) score

  1 and 2 years after treatment

Study Arms (2)

Smart nitinol stent implantation group

EXPERIMENTAL

The Smart nitinol stent system was used (import product registration number YZB/USA 0115-2008; Nitinol stent system, trade name SMART Control). The stent system comprises a self-expanding stent and a delivery system. The self-expanding stent is composed of a nickel titanium alloy and the ends of the stent are equipped with tantalum radiopaque markers. The Smart nitinol stent system is sterilized with ethylene oxide gas and is intended for single use only.

Device: Smart nitinol stent implantation

Antiplatelet drug group

ACTIVE COMPARATOR

Patients with carotid artery stenosis treated conservatively were commenced on an indefinite course of one or more oral antiplatelet drugs. The antiplatelet regimes comprised 100 mg or 300 mg aspirin before sleep with clopidogrel 125 mg or 250 mg daily; or 75 mg clopidogrel before sleep daily.

Drug: antiplatelet drug

Interventions

Smart nitinol stent implantation DEVICE

Before intervention, clopidogrel (75 mg/d), aspirin (100 mg/d) and atorvastatin (40 mg/d) were prescribed. One week later, aortic arch and aortocranial angiography were performed under general anesthesia to determine the site, range and extent of the lesion and the status of the cerebral microcirculation, and consequently to inform the treatment strategy and the selection of the correct size of self-expanding nitinol stent system.

Smart nitinol stent implantation group

antiplatelet drug DRUG

Patients with carotid artery stenosis treated conservatively were commenced on an indefinite course of one or more oral antiplatelet drugs. The antiplatelet regimes comprised 100 mg or 300 mg aspirin before sleep with clopidogrel 125 mg or 250 mg daily; or 75 mg clopidogrel before sleep daily.

Also known as: aspirin and clopidogrel

Antiplatelet drug group

Eligibility Criteria

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

You may qualify if:

• Age \>18 years
• Of either sex
• Carotid artery stenosis caused by atherosclerotic plaque
• Diagnosed with severe atherosclerotic carotid stenosis according to a previously described method (North American Symptomatic Carotid Endarterectomy Trial Collaborators, 1991)
• Severe carotid artery stenosis confirmed by transcranial Doppler and carotid duplex ultrasonography
• Provision of informed consent regarding trial procedure

You may not qualify if:

• Carotid artery stenosis caused by fibromuscular dysplasia, Takayasu's arteritis or radiation injury
• Severe central nervous system disorders, such as complete loss of cerebral function on the affected side with cerebral paralysis
• Life expectancy \<2 years because of intracranial tumors or other diseases
• Pregnant or lactating
• Renal impairment (if use of contrast agent will worsen renal function)
• Concurrent hemorrhagic disease, or contraindication to antiplatelet or anticoagulant therapies for safety reasons
• Leakage of contrast agent indicative of vessel perforation
• Dilated aneurysm proximal or distal to stenotic foci
• Allergy to stent material
• Complete occlusion of the carotid artery or lesion length \>10 mm, accompanied by intravascular thrombus and multiple segments of stenosis confirmed by imaging examination
• Intracranial hemorrhage within 3 weeks or large areas of cerebral infarction within 4 weeks of treatment
• 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 Jishuitan Hospital: lead

MeSH Terms

Conditions

Carotid Stenosis

Interventions

Platelet Aggregation Inhibitors; Aspirin; Clopidogrel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Hematologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Zhigang Ma, Master

  Beijing Jishuitan Hospital, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: June 12, 2016
• First Posted: June 15, 2016
• Study Start: June 1, 2006
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2008
• Last Updated: June 15, 2016

Record last verified: 2016-06