Drug Eluting Temporary Spur Stent System vs Percutaneous Balloon Angioplasty for the Treatment of Critical Limb Ischemia
NCT06122974
Arterial Occlusive Diseases, Arteriosclerosis
View Trial DetailsNCT Number: NCT06191237
We wish to conduct two vascular ultrasound scans conducting vein measurements in two separate scanning rooms to assess if environmental temperature affects the vein diameter recorded.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Vascular surgeons are guided by vascular ultrasound scans when deciding treatment plans for their patients. In critical limb threatening ischaemia with infrainguinal disease, vein bypass has the best limb salvage and long term survival rates in patients who are appropriately selected. In lower limb "vein mapping", the vein is measured to assess suitability for use as a bypass conduit with the favoured bypass conduit being autologous, ipsilateral vein of good quality and length and a size of >3mm is considered a good conduit.
The research team found one study which explored the effect of room temperature on upper limb vein measurements which was conducted in Singapore. This showed an underestimation of vein size at lower temperatures. We wish to add to the literature and irish research by conducting this study at University Hospital Limerick in order to optimise conditions for vascular assessments and therefore facilitate clinical decision making.
We aim to scan and record vein measurements on the lower limbs of vascular inpatients at University Hospital Limerick who are deemed suitable by the P.I.
Patients will have the ultrasound scan completed twice. The first room will have its temperature recorded and the vein measurements taken.
The second room will be set at a higher temperature which we have defined as being 6-10 degrees greater than ambient room temperature. We will achieve this through use of a portable heater.
We will compare the two recordings to assess if there is a difference in the diameter of the vein measured in the warmer room versus the standard room.
The importance of this is to assess the impact of environmental factors on vascular ultrasound scan results, therefore impacting on patient outcomes by use of the most suitable bypass conduit.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 3 months
Two vascular ultrasound scans will be performed on the lower limb. A defined scanning protocol will be adhered to which will ensure consistency and accuracy.
During the course of both ultrasound scans, vein measurements will be taken and recorded on the study sheet which will have the participant study identification number, age and gender.
The second room will be set at a higher temperature which we have defined as being 6-10 degrees greater than ambient room temperature.
Contact information is provided by the study sponsor or research team.
University Hospital of Limerick
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06122974
Arterial Occlusive Diseases, Arteriosclerosis
View Trial DetailsNCT06795620
Arterial Occlusive Diseases, Arteriosclerosis
Toulouse, France
View Trial DetailsNCT06544135
Arterial Occlusive Diseases, Arteriosclerosis
Beachwood, Ohio, United States
View Trial DetailsNCT03982693
Arterial Occlusive Diseases, Arteriosclerosis
Miami Beach, Florida, United States
View Trial Details