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Stenting Versus Best Medical Treatment of Asymptomatic High Grade Carotid Artery Stenosis

NCT00497094 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2013-02-28

No results posted yet for this study

Summary

Background. Carotid artery stenting (CAS) recently has become an accepted method for treatment of patients with high-grade carotid artery stenosis, who are at an increased risk for surgical carotid endarterectomy (CEA). The reported rates of neurological complications of CAS substantially decreased during the past years, and the routine use of cerebral protection devices and low profile catheter systems have further increased the procedure´s safety. In the early 90's large surgical trials in North America and Europe (NASCET, ECST and ACAS) demonstrated superiority of CEA compared to best medical treatment for symptomatic and asymptomatic patients. Provided that the ongoing randomized controlled trials comparing CAS and CEA confirm equivalence between the these methods, CAS similar to CEA is applicable to symptomatic and asymptomatic patients with high grade carotid stenosis. However, particularly in asymptomatic patients, the indication for revascularisation remains debatable. Protected CAS is associated with a very low rate of neurological complications, which are below the AHA recommendation for treating asymptomatic patients (3%). However, the introduction of new vascular protective medications like statins and clopidogrel during the recent years substantially improved the spectrum of best medical treatment, and the findings of NASCET, ECST and ACAS with respect to best medical treatment may therefore not be applicable any more.

Study hypothesis and aims. Given the low frequency of spontaneous neurological complications, the preferable therapeutic approach to patients with asymptomatic high grade ( \> 80%) carotid artery stenoses is currently unknown. Modern best medical treatment may manage to stabilize the atherosclerotic plaque, while CAS has the potential of resolving the carotid stenosis. Comparative data, however, are not available as yet. We hypothesized that protected CAS has a beneficial effect on occurrence of ipsilateral neurological complications and major adverse cardiac events in high-risk patients with asymptomatic \> 80% internal carotid artery stenosis. Therefore, the aim of the present randomized controlled trial was to analyze neurological and cardiovascular outcome of patients treated with elective CAS plus best medical treatment compared to best medical treatment only.

Conditions

  • Asymptomatic
  • Artery

Interventions

DEVICE

carotid artery stenting

Using retrograde transfemoral access an overview aortic angiogram is established. A stiff wire is then placed in the external carotid or distal common carotid artery to introduce a long hydrophilic sheath into the common carotid artery. The stenosis is then crossed with a Filter wire. For stent implantation Monorail Carotid Wallstents or the Monorail Nitinol Stent of Boston Scientific are used. Road map or overlay technique with a magnification of 20 to 28 inch is used to localize the stenosis during the procedure. Finally a control angiogram is performed to ensure correct placement of the stent. After successful completion of the procedure, the arterial access site is closed using a standard closure device.

Sponsors & Collaborators

  • Vienna General Hospital

    lead OTHER

Principal Investigators

  • Martin Schillinger, Prof. Dr. · General Hospital of Vienna

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-03-31
Primary Completion
2010-06-30
Completion
2011-10-31

Countries

  • Austria

Study Locations

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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 NCT00497094 on ClinicalTrials.gov