PAD - Peripheral Arterial DiseaseCLE-PADNCT07469020
CLE-PAD : Prevalence of PAD in Patients With Surgically Lumbar Spinal Stenosis
A study testing contrast-enhanced CT scan in people with PAD - Peripheral Arterial Disease and Lumbar Spinal Stenosis, run by Rennes University Hospital at 3 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PAD - Peripheral Arterial Disease, Lumbar Spinal Stenosis, Lower Limb Arterial Disease
- What is being tested?
- contrast-enhanced CT scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 3 sitesFrance
- Study dates
- Aug 2026to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presenting with a lumbar spinal stenosis with surgical indication, either unoperated or operated on less than 3 months ago
- Affiliated with a social security scheme
- Having received oral and written information about the protocol and having signed a written consent form to participate in this research.
Who cannot join
- emergency surgical care
- Contraindication to contrast enhanced CT scan
- Stroke or myocardial infarction (MI) within the last 3 months
- Known severe or poorly tolerated arrhythmia
- Known severe or symptomatic left ventricular outflow obstruction
- Decompensated heart failure
Show all 11Show fewer
- History within the last 3 months of venous thromboembolic disease, myopericarditis, endocarditis, aortic dissection or intracardiac thrombus
- Severe uncontrolled hypertension (BP > 200/110 mmHg)
- Inability to walk on the treadmill
- Major lower limb amputation
- Adult subject to legal protection
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Not yet recruiting
Groupement des Hôpitaux de l'Institut Catholique de Lille
Lille
Marjolaine Talbot, +33320225000, talbot.marjolaine@ghicl.net
Marjolaine Talbot
- Not yet recruiting
Groupe hospitalier Paris Saint Joseph
Paris
Ewa Tuleja, +33144127137, etuleja@ghpsj.fr
Ewa Tuleja
- Recruiting
CHU Rennes
Rennes
Marie Charasson, +33299284321, marie.charasson@chu-rennes.fr
Marie Charasson
About this study
Official title: CLE-PAD : Prevalence of Lower Extremity Peripheral Artery Disease in Patients With Surgically Lumbar Spinal Stenosis
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.
Read the 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.
- Being tested
- contrast-enhanced CT scan
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
contrast-enhanced CT scanDiagnostic test
contrast-enhanced CT scan
| Study group | Role | What they receive |
|---|---|---|
| Participants | Experimental | Not described Receives: Diagnostic Test: contrast-enhanced CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with PAD identified during the contrast enhanced CT scan
Number of patients with PAD identified during the contrast enhanced CT scan. PAD will be defined by the presence of at least one arterial stenosis ≥ 50% on the arterial axes located from the abdominal aorta to the origin of the tibiofibular arterial trunk, as determined by CT scan of the aorta and lower limbs in accordance with the recommendations.
Measured: 3 months
Secondary outcomes (5)
Efficiency of diagnosis test "pulse"
determination of the sensitivity and specificity, positive predictive value and negative predictive value of the diagnostic test "pulse" : the absence of distal pulses will be considered pathological
Measured: 3 months
Efficiency of diagnosis test "systolic pressure index"
determination of the sensitivity and specificity, positive predictive value and negative predictive value of the diagnostic test "systolic pressure index" : A resting systolic pressure index ≤ 0.90 will be considered pathological in accordance with the recommendations.
Measured: 3 months
Efficiency of diagnosis test "toe systolic pressure index"
determination of the sensitivity and specificity, positive predictive value and negative predictive value of the diagnostic test "toe systolic pressure index" : A resting toe systolic pressure index ≤ 0.70 will be considered pathological in accordance with the recommendations.
Measured: 3 months
Efficiency of diagnosis test "Aorto-iliac and lower limb Doppler ultrasound"
determination of the sensitivity and specificity, positive predictive value and negative predictive value of the diagnostic test "Aorto-iliac and lower limb Doppler ultrasound " : velocimetric criteria for stenosis and Saint-Bonnet B and CD, E and 0 Doppler curves considered pathological (i.e. AOMI) in accordance with recommendations .
Measured: 3 months
Efficiency of diagnosis test "exercise oxymetry"
determination of the sensitivity and specificity, positive predictive value and negative predictive value of the diagnostic test "exercise oxymetry " : Delta from rest oxygen pressure (DROP) ≤ -15 mmHg will be considered pathological (i.e. AOMI) in accordance with the recommendations. .
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study startAug 2026 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PAD - Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marjolaine Talbot, Study chair, Groupement des Hôpitaux de l'Institut Catholique de Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07469020
- Sponsor's protocol ID
- 35R24_8825_04_CLE-PAD
- Acronym
- CLE-PAD
- Status last verified
- Aug 2026
- First submitted
- 9 Mar 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLE-PAD : Prevalence of Lower Extremity Peripheral Artery Disease in Patients With Surgically Lumbar Spinal Stenosis
- ClinicalTrials.gov ID
- NCT07469020
- Acronym / sponsor ID
- CLE-PAD / 35R24_8825_04_CLE-PAD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | Experimental | Diagnostic Test: contrast-enhanced CT scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Presenting with a lumbar spinal stenosis with surgical indication, either unoperated or operated on less than 3 months ago
- Affiliated with a social security scheme
- Having received oral and written information about the protocol and having signed a written consent form to participate in this research.
Key exclusion criteria (11 listed)
- emergency surgical care
- Contraindication to contrast enhanced CT scan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| contrast-enhanced CT scancontrast-enhanced CT scan | Diagnostic test | Participants |
Primary outcome
Number of patients with PAD identified during the contrast enhanced CT scan
Time frame: 3 months
Number of patients with PAD identified during the contrast enhanced CT scan. PAD will be defined by the presence of at least one arterial stenosis ≥ 50% on the arterial axes located from the abdominal aorta to the origin of the tibiofibular arterial trunk, as determined by CT scan of the aorta and lower limbs in accordance with the recommendations.
5 secondary outcomes
Efficiency of diagnosis test "pulse"
Time frame: 3 months
Efficiency of diagnosis test "systolic pressure index"
Time frame: 3 months
Efficiency of diagnosis test "toe systolic pressure index"
Time frame: 3 months
Efficiency of diagnosis test "Aorto-iliac and lower limb Doppler ultrasound"
Time frame: 3 months
Efficiency of diagnosis test "exercise oxymetry"
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marjolaine Talbot study chair
Groupement des Hôpitaux de l'Institut Catholique de Lille
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing contrast-enhanced CT scan in people with PAD - Peripheral Arterial Disease and Lumbar Spinal Stenosis, run by Rennes University Hospital at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie-Laure Gervais (+33299284321, marie-laure.gervais@chu-rennes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with PAD identified during the contrast enhanced CT scan (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.