The primary aim of the proposed study is to assess whether stenting for symptomatic vertebral artery stenosis >= 50% is feasible and safe. A secondary aim is to assess the rate of new vascular events in the territory of the vertebrobasilar…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
- Vascular therapeutic procedures
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is any stroke, vascular death, or non-fatal myocardial
infarction within 30 days after start of treatment.
Secondary outcome
Secondary outcome measures include any stroke or vascular death during
follow-up, stroke in the VB territory within 30 days and during follow-up, and
the degree of (re)stenosis after one year.
Background summary
Twenty to 30 percent of all transient ischaemic attacks (TIA*s) and ischaemic
strokes involve tissue supplied by the vertebrobasilar (VB) circulation.
Atherosclerotic stenosis >= 50% in the vertebral artery accounts for VB stroke
in at least one third of the patients. In contrast to carotid stenosis, the
risk of recurrent vascular events in patients with vertebral stenosis is
uncertain and revascularisation of vertebral stenosis to prevent such recurrent
vascular events is rarely performed. Observational studies have suggested that
the risk of subsequent stroke or death in patients with VB events is comparable
to that in patients with carotid territory events. In the last decade,
treatment of vertebral stenosis by percutaneous transluminal angioplasty,
usually with stent placement, has been introduced as an attractive treatment
option. Case series have suggested that this technique may reduce the risk of
recurrent stroke, but this has not been demonstrated in a single randomised
clinical trial. Particularly, the safety and benefit of stenting of symptomatic
vertebral stenosis as compared with best medical therapy alone remains to be
elucidated.
Study objective
The primary aim of the proposed study is to assess whether stenting for
symptomatic vertebral artery stenosis >= 50% is feasible and safe. A secondary
aim is to assess the rate of new vascular events in the territory of the
vertebrobasilar arteries in patients with symptomatic vertebral artery stenosis
>= 50% on best medical therapy alone. The results of the proposed study will
serve to design a large and conclusive randomised clinical trial of stenting
for symptomatic vertebral artery stenosis.
Study design
This is a randomised, open clinical trial with masked outcome assessment,
comparing a combination of vertebral artery stenting and best medical treatment
with best medical treatment alone in patients with recently symptomatic
vertebral artery stenosis of at least 50%.
Intervention
The trial will compare a combination of vertebral artery stenting and best
medical treatment with best medical treatment alone.
Study burden and risks
The major risk of endovascular treatment is dislodgement and distal
embolisation of plaque and thrombotic debris, which may lead to stroke. The
periprocedural risk of stroke or death probably lies between 2 and 8%. Other
neurological complications, such as vertebral artery dissection, may occur in 3
to 6.0% of the cases, and non-neurological complications, such as inguinal
haematoma, in 1% to 3%.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
1. TIA or non-disabling ischaemic stroke of the posterior circulation
2. symptoms must have occurred in the 180 days preceding randomisation
3. possibility to perform stenting within two weeks after randomisation
4. stenosis of the vertebral artery of 50% or greater, diagnosed by at least two imaging modalities, and presumed to be of atherosclerotic origin and accessible for endovascular treatment
5. score on the modified Rankin scale <= 3 (independent in daily activities, although some help may be needed)
6. age 18 years or older
7. written informed consent
Exclusion criteria
1. potential cause of TIA or minor stroke other than stenosis in a vertebral artery
2. vertebral artery stenosis caused by arterial dissection
3. previous surgical or endovascular treatment of the stenosis
4. life expectancy shorter than three years
5. other serious illness that may confound outcome assessment
6. severe renal impairment, precluding contrast administration
7. history of severe allergic reaction to iodonised contrast agent
8. pregnancy
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL19062.041.07 |