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Trial record 6 of 10 for:    "Carotid Stenosis" | "Clopidogrel"

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

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ClinicalTrials.gov Identifier: NCT02800174
Recruitment Status : Completed
First Posted : June 15, 2016
Last Update Posted : June 15, 2016
Sponsor:
Information provided by (Responsible Party):
Zhigang Ma, Beijing Jishuitan Hospital

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

Condition or disease Intervention/treatment Phase
Carotid Artery Stenosis Device: Smart nitinol stent implantation Drug: antiplatelet drug Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of the Smart Nitinol Stent System for the Treatment of Severe Atherosclerotic Carotid Stenosis: Study Protocol for a Retrospective, Non-randomized, Long-term Parallel Controlled Trial
Study Start Date : June 2006
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arm Intervention/treatment
Experimental: Smart nitinol stent implantation group
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
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.

Active Comparator: Antiplatelet drug group
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
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.
Other Name: aspirin and clopidogrel




Primary Outcome Measures :
  1. mRS score [ Time Frame: 2 years after treatment ]
    The mRS is a 7-point scale used to evaluate a patient's functional recovery.


Secondary Outcome Measures :
  1. The recurrence of cerebrovascular events [ Time Frame: 1 and 2 years after treatment ]
    The incidences of transient cerebral ischemia, cerebral infarction, cerebral hemorrhage or death because of cerebrovascular diseases will be recorded.

  2. National Institute of Health stroke scale(NIHSS) score [ Time Frame: 1 and 2 years after treatment ]
    The NIHSS is a 43-point scale, with higher scores indicative of more severe neurological deficits.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02800174


Sponsors and Collaborators
Beijing Jishuitan Hospital
Investigators
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Principal Investigator: Zhigang Ma, Master Beijing Jishuitan Hospital, China

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Responsible Party: Zhigang Ma, Director, Beijing Jishuitan Hospital
ClinicalTrials.gov Identifier: NCT02800174     History of Changes
Other Study ID Numbers: BeijingJH_001
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: June 15, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Carotid Stenosis
Clopidogrel
Constriction, Pathologic
Pathological Conditions, Anatomical
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Aspirin
Platelet Aggregation Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists