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

NCT02800174 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2016-06-15

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Beijing Jishuitan Hospital

    lead OTHER

Principal Investigators

  • Zhigang Ma, Master · Beijing Jishuitan Hospital, China

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2007-06-30
Completion
2008-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02800174 on ClinicalTrials.gov