ClinicalTrials.Veeva

Menu

Femoral vs Radial Approach and MRI Evaluation of Strokes

C

Caen University Hospital

Status

Completed

Conditions

Aortic Stenosis

Treatments

Behavioral: vascular access site

Study type

Observational

Funder types

Other

Identifiers

NCT00329979
No additional Ids
2006-18

Details and patient eligibility

About

Symptomatic cerebral infarction following cardiac catheterization is rare but silent brain injury could occur at an unexpectedly high rate. One study has found that up to 22% of patients with severe aortic stenosis who have undergone retrograde catheterization of the valve can be identified as having new ischemic lesions as detected by diffusion-weighted (DW) magnetic resonance imaging (MRI). During cardiac catheterization, cerebral microembolism as detected by TCD has frequently been observed, but whether it is clinically relevant remains unknown . However, recent studies have suggested that some of these microemboli could be responsible for acute brain injury, as documented by DW MRI.

Indeed the high sensitivity of DW MRI suggests that this technique could allow an improved estimate of cerebral ischemic events associated with cardiovascular-catheter procedures. We therefore decided to perform DW MRI before and after cardiac catheterization to prospectively assess both clinically silent and apparent cerebral embolisms for the first time in a multicenter trial. Furthermore, a randomization between radial and femoral access will allow assessment of risk of silent brain injury associated with the different vascular access sites.

Enrollment

152 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patient with significant aortic valve stenosis before planned surgery.

Exclusion criteria

  • Contraindication to MRI or inability to give written informed consent.

Trial design

152 participants in 2 patient groups

1
Description:
Radial access
Treatment:
Behavioral: vascular access site
2
Description:
Femoral access
Treatment:
Behavioral: vascular access site

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems