Prevalence of PAD in Patients With Surgically Treated Lumbar Spinal Stenosis
Official title: CLE-PAD : Prevalence of Lower Extremity Peripheral Artery Disease in Patients With Surgically Lumbar Spinal Stenosis
Run by Rennes University Hospital · NCT07469020 · Data updated 2026-11-12
This study tests how common peripheral artery disease is in people who have lumbar spinal stenosis and are being considered for, or have had, surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 49 (estimated) |
| Sponsor | Rennes University Hospital Academic / other |
| Locations | 3 sites (Lille and 2 other locations) |
| Status | Recruiting |
| Started | August 2026 |
| Main results expected | August 2026 |
| Study ends | August 2026 |
| Registry record updated | August 12, 2026 |
| Trial ID | NCT07469020 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with lumbar spinal stenosis who are candidates for or have recently undergone lumbar spine surgery and who have or are suspected to have PAD.
✕Probably not a fit
Patients without PAD or without feasibility for the diagnostic procedures may derive no direct benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study aims to determine how often peripheral artery disease coexists with lumbar spinal stenosis in adults undergoing surgical evaluation or treatment. Participants will undergo a contrast-enhanced CT scan of the lower limb arteries and a set of routine vascular tests (Doppler ultrasound, treadmill tests, and pulse-pressure measurements) to compare their diagnostic accuracy for PAD in this population. The study also includes specialized stress TcPO2 tests and an injected lower-limb aorta scan to better characterize vascular status. By identifying the prevalence and the most accurate diagnostic approach, findings could improve preoperative assessment and postoperative outcomes for patients with LSS and suspected PAD.
Why it matters
Potential benefit: If successful, the study could improve preoperative screening for PAD in patients with lumbar spinal stenosis, potentially guiding treatment decisions and reducing postoperative complications.
How similar studies have gone: Previous work has explored PAD prevalence in general populations, but this approach focusing on the LSS group with direct comparison of diagnostic tools is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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 * 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
Where it's running
-
CHU Rennes
Rennes, France Recruiting -
Groupement des Hôpitaux de l'Institut Catholique de Lille
Lille, France Not yet recruiting -
Groupe hospitalier Paris Saint Joseph
Paris, France Not yet recruiting
Study contacts
- Study coordinator: Marie-Laure Gervais
- Email: marie-laure.gervais@chu-rennes.fr
- Phone: +33299284321
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.