Stroke/vertebral stenosis Circulatory System Stroke
Conditions
Interventions
Current interventions as of 06/02/2013:
Patients will be randomised to treatment by stenting or standard drug treatment alone. All patients entering the study will receive the best pos
Sponsors
Cambridge University Hospitals NHS Foundation Trust & University of Cambridge (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 06/02/2013: 1. Women or men aged greater than 20 years of age 2. Symptomatic vertebral stenosis resulting from presumed atheromatous disease 3. Severity of stenosis at least 50% as determined by magnetic resonance angiography (MRA) or computed tomography angiography (CTA) or intra-arterial angiography 4. Symptoms of transient ischaemic attack (TIA) or stroke within the last three months 5. Patient able to provide written informed consent, be willing to be randomised to either treatment, and be willing to participate in follow-up 6. If randomised to stenting, this can be performed within two weeks after randomization. Previous inclusion criteria until 06/02/2013: 1. Women or men aged greater than 20 years of age 2. Symptomatic vertebral stenosis resulting from presumed atheromatous disease 3. Severity of stenosis at least 50% as determined by magnetic resonance angiography (MRA) or computed tomography angiography (CTA) or intra-arterial angiography 4. Symptoms of transient ischaemic attack (TIA) or stroke within the last six months 5. Patient able to provide written informed consent, be willing to be randomised to either treatment, and be willing to participate in follow-up
Exclusion criteria
Exclusion criteria: 1. Patients unwilling or unable to give informed consent 2. Patients unwilling to accept randomisation to either treatment arm 3. Vertebral stenosis caused by acute dissection as this has a different natural history and usually spontaneously improves 4. Patients in whom vertebral stenting is felt to be technically not feasible e.g. access problems 5. Previous stenting in the randomised artery 6. Pregnant and lactating women
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 06/02/2013: 1. Fatal or non-fatal stroke in any arterial territory (including periprocedural stroke) at three months post-randomisation 2. Posterior circulation stroke (including periprocedural stroke) during follow-up 3. Periprocedural stroke or death (within 30 days of procedure) 4. Posterior circulation stroke and TIA during follow-up 5. Any disabling stroke (defined by a Rankin >=3) during follow-up 6. Death of any cause during follow-up 7. Restenosis in treated artery during follow-up 8. NHS and personal social services costs 9. Quality-adjusted life years 10. Within-trial and long-run incremental cost-effectiveness Previous secondary outcome measures until 06/02/2013: 1. Posterior circulation stroke (including periprocedural stroke) during follow-up 2. Posterior circulation stroke and TIA during follow-up 3. Periprocedural stroke and death (within one month of procedure) 4. Periprocedural stroke, death, and TIA (within one month of procedure) 5. Restenosis in treated artery during follow-up | — |
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 06/02/2013: Fatal or non-fatal stroke in any arterial territory (including periprocedural stroke) during trial follow up Previous primary outcome measures until 06/02/2013: Fatal or disabling stroke in any arterial territory (including periprocedural stroke) defined as a Rankin score of greater than or equal to three, at three months post stroke. | — |
Countries
United Kingdom
Outcome results
None listed