Vertebral artery Ischaemia Stenting Trial

Not Applicable

Completed

• Conditions: Stroke/vertebral stenosis; Circulatory System; Stroke

• Registration Number: ISRCTN95212240
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust & University of Cambridge (UK)

Brief Summary

2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31422789 (added 21/08/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-03-04
• Study Completion: 2017-11-01
• Last Update Posted: 9 September 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 61

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Current primary outcome measures as of 06/02/2013:<br> Fatal or non-fatal stroke in any arterial territory (including periprocedural stroke) during trial follow up<br><br> Previous primary outcome measures until 06/02/2013:<br> 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.<br>