Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 9:11 PM
Study NCT ID:
NCT07469020
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-13
First Post:
2026-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CLE-PAD : Prevalence of PAD in Patients With Surgically Lumbar Spinal Stenosis
Sponsor:
Rennes University Hospital
Organization:
Study Overview
Official Title:
CLE-PAD : Prevalence of Lower Extremity Peripheral Artery Disease in Patients With Surgically Lumbar Spinal Stenosis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CLE-PAD
Brief Summary:
The goal of this interventional study is to evaluate the rate of existing lower limb peripheral artery disease (PAD) in patients with surgically lumbar spinal stenosis (LSS). PAD and LSS can present similar symptoms and it can be difficult to diagnose PAD using conventional methods, depending on the location of the arterial disease. The main questions it aims to answer are :
* What's the prevalence of PAD in LSS patients?
* Which exam among routine tools is the most accurate to diagnose PAD in this population? Around their surgery for LSS (a few weeks before or after), participants will be included in a vascular medicine service. After checking of eligibility criteria, they will undergo a contrast-enhanced CT scan for the diagnosis of PAD and various routine diagnostic tests: Doppler ultrasound, treadmill tests, pressure index, pulse palpation.
* What's the prevalence of PAD in LSS patients?
* Which exam among routine tools is the most accurate to diagnose PAD in this population? Around their surgery for LSS (a few weeks before or after), participants will be included in a vascular medicine service. After checking of eligibility criteria, they will undergo a contrast-enhanced CT scan for the diagnosis of PAD and various routine diagnostic tests: Doppler ultrasound, treadmill tests, pressure index, pulse palpation.
Detailed Description:
Lumbar spinal stenosis (LSS) is a debilitating degenerative condition in older people associated with lower back pain, pain in the lower limbs and a reduced quality of life. LSS can be treated surgically, but the results are mixed: 35% of patients report low satisfaction one year after surgery. The symptoms of LSC in the lower limbs can mimic those associated with peripheral arterial disease (PAD). The prevalence of PAD in the LSC population varies between 4.1% and 67.8% depending on the diagnostic tests used and the populations studied. Thus, the precise analysis of the prevalence of PAD and the sensitivity and specificity of PAD diagnostic tests in this population remain to be determined. These analyses would help to optimise PAD diagnostic tools, while possibly providing an explanation for the post-operative persistence of functional discomfort in CLE patients. Furthermore, a better understanding of the vascular system in the CLE population offers hope for optimising patient care, both from a medical and a medico-economic point of view.
The experimental visit takes place as soon as possible after receipt of the biological assessment and within a maximum period of 3 months. During this visit, specific research examinations will be performed, including stress tests (stress TcPO2 according to the modified Strandness protocol and stress TcPO2 according to the Gardner-Skinner increasing load protocol), as well as an injected scan of the aorta of the lower limbs. The pseudonymised CT scan will be sent to the sponsor for blind review. A follow-up telephone call will be made between 7 and 10 days after the CT scan to detect the occurrence of any adverse events. The study will then be completed for the participant.
The experimental visit takes place as soon as possible after receipt of the biological assessment and within a maximum period of 3 months. During this visit, specific research examinations will be performed, including stress tests (stress TcPO2 according to the modified Strandness protocol and stress TcPO2 according to the Gardner-Skinner increasing load protocol), as well as an injected scan of the aorta of the lower limbs. The pseudonymised CT scan will be sent to the sponsor for blind review. A follow-up telephone call will be made between 7 and 10 days after the CT scan to detect the occurrence of any adverse events. The study will then be completed for the participant.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: