An interventional study of contrast-enhanced CT scan in PAD - Peripheral Arterial Disease, Lumbar Spinal Stenosis and Lower Limb Arterial Disease, sponsored by Rennes University Hospital. Recruiting at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Rennes University Hospital · Not applicable, Interventional, and Diagnostic
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 :
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.
458 studies on the registry are indexed under Spinal Stenosis; 105 are open to participants now.
This study's planned enrollment of 49 is below the median of 80 across 281 interventional studies indexed under Spinal Stenosis.
Browse Spinal Stenosis studies →Rennes University Hospital is the lead sponsor of 451 studies on the registry; 51 are open to participants now.
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Exclusion Criteria:
to contrast enhanced CT scan
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Diagnostic Test: contrast-enhanced CT scan
contrast-enhanced CT scan
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.
Time frame: 3 months
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
Time frame: 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.
Time frame: 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.
Time frame: 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 .
Time frame: 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. .
Time frame: 3 months
Start is estimated for Aug 2026; primary completion for Aug 2026, 0 months later.
Of 105 non-industry interventional studies with no phase under Spinal Stenosis, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 46. This study's planned 0 months is below that.
Counting every sponsor, half of 123 studies reached it within 30 months; a quarter within 12 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
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