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Stenting of symptomatic vertebral artery stenosis. A randomised safety and feasibility study

Stenting of symptomatic vertebral artery stenosis. A randomised safety and feasibility study - VAST: Vertebral Artery Stenting Trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON38025
Enrollment
180
Registered
2008-01-22
Start date
2008-06-25
Completion date
Unknown
Last updated
2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

vertebral artery stenosis

Interventions

The trial will compare a combination of vertebral artery stenting and best medical treatment with best medical treatment alone.

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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 outcomes

Primary

MeasureTime frame
The primary outcome is any stroke, vascular death, or non-fatal myocardial infarction within 30 days after start of treatment.

Secondary

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)