Asymptomatic Clinical Trial
Official title:
Stenting vs. Best Medical Treatment of Asymptomatic High Grade Carotid Artery Stenosis - a Randomized Controlled Trial
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.
Status | Completed |
Enrollment | 148 |
Est. completion date | October 2011 |
Est. primary completion date | June 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Atherosclerosis is the underlying disease - Patients with an asymptomatic stenosis >80% (NASCET) with a documented progression of the degree of stenosis to >80% within 6 months with a very tight stenosis =90% at initial presentation with a >80% stenosis plus silent ipsilateral ischemia documented by CCT or MRI with ipsilateral >80% stenosis plus contralateral >80% stenosis or occlusion with >80% stenosis plus planned major surgery - Neurologist´s explicit consent to potentially perform CAS Exclusion Criteria: - Inability to provide informed consent - Underlying disease other than atherosclerosis (inflammatory or autoimmune disease) - Traumatic or spontaneous carotid dissections - Life expectancy <6 months - Advanced dementia - Advanced renal failure (serum creatinine >2.5 mg/dL) - Unstable severe cardiovascular comorbidities (e.g. unstable angina, heart failure) - Restenosis after prior CAS or CEA - Allergy or contraindications to study medications (clopidogrel, statins, ASA) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
Austria | General Hospital of Vienna | Vienna |
Lead Sponsor | Collaborator |
---|---|
Vienna General Hospital |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary study endpoints: neurological events (ipsilateral and contralateral), major adverse cardiovascular events (MACE: composite of myocardial infarction, stroke and cardiovascular death) and any death | 24 months | Yes | |
Secondary | in-stent restenosis after CAS, neuropsychological function, patient satisfaction, quality of life during follow up. | 24 months | Yes |
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