NCT07469020

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 13, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Completed
Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

3 months

First QC Date

March 9, 2026

Last Update Submit

March 9, 2026

Conditions

PAD - Peripheral Arterial DiseaseLumbar Spinal StenosisLower Limb Arterial Disease

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months

Secondary Outcomes (5)

  • Efficiency of diagnosis test "pulse"

    3 months

  • Efficiency of diagnosis test "systolic pressure index"

    3 months

  • Efficiency of diagnosis test "toe systolic pressure index"

    3 months

  • Efficiency of diagnosis test "Aorto-iliac and lower limb Doppler ultrasound"

    3 months

  • Efficiency of diagnosis test "exercise oxymetry"

    3 months

Study Arms (1)

Participants

EXPERIMENTAL
Diagnostic Test: contrast-enhanced CT scan

Interventions

contrast-enhanced CT scanDIAGNOSTIC_TEST

contrast-enhanced CT scan

Participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Groupement des Hôpitaux de l'Institut Catholique de Lille

Lille, France

Location

Groupe hospitalier Paris Saint Joseph

Paris, France

Location

CHU Rennes

Rennes, France

Location

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Marjolaine Talbot

    Groupement des Hôpitaux de l'Institut Catholique de Lille

    STUDY CHAIR

Central Study Contacts

Marie-Laure Gervais

CONTACT

+33299284321marie-laure.gervais@chu-rennes.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2026

First Posted

March 13, 2026

Study Start

May 1, 2026

Primary Completion

August 1, 2026

Study Completion

August 1, 2026

Last Updated

March 13, 2026

Record last verified: 2026-03

Locations

FR(3)