External Iliac Artery Endofibrosis in Cycling

NCT07194330 | Active Not Recruiting

• 1 other identifier: M10/2025/304
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

A data request will be made regarding the tests conducted by the subject related to their performance, as well as the results of the medical diagnostic tests performed. The requested data/variables pertain to physical performance: power output on the pedals during training sessions, tests, and competitions, as well as medical tests during the diagnostic process.

Conditions

Iliac Artery Occlusive Disease; Blood Flow Velocity; Performance; Cycling

Keywords

External Iliac Artery; Endofibrosis; Cycling; Angiology

Outcome Measures

Primary Outcomes (6)

• Eco-Doppler with colour

  The results of distal systolic flow at rest and after a performance claudication test will be assessed. These will be measured using imaging to provide qualitative control of the results, as well as by evaluating the peak systolic flow velocity in the external iliac artery in centimeters per second (cm/s).

  12 months pre-intervention/procedure/surgery; 12 months post-intervention/procedure/surgery.

• Performance data in training and competition

  Data of power applied on pedals´powermeter will be collected, data will be from 2022 to 2025 training and competitive seasons, it will be collected as power in watts applied by cyclist during pedal stroke, conidered as external load. External load developed by participant during trainings and competitions will be collected in raw format, as watts applied by participant meassured by his powermeter installed in his bicycle second by second.

  3 years "pre" and 2 years "post intervention/surgery", and during study completion, a total of 5 years of time frame

• Distal systolic and dyastolic pressure

  Distal systolic and diastolic pressure will be assessed before and after a specific claudication test, and it will be recorded in millimeters of mercury (mmHg).

  12 months pre-intervention/procedure/surgery; 12 months post-intervention/procedure/surgery.

• Angiography

  The angiography test will be carried out using computed tomography and intravascular ultrasound examinations via catheterization. Imaging results from angiography will be collected, the thickness of the arterial wall will be measured in millimeters, and a qualitative structural assessment of the imaging will be performed."

  12 months pre-intervention/procedure/surgery

• Outcomes during surgery

  During the surgery, the results obtained from the procedure, as well as the applied technique, will be presented, potentially in the form of images or explanatory diagrams of the process.

  Perioperative/Periprocedural

• Lactate thresholds test

  The lactate threshold test will be performed to assess the power (watts) developed by the participant. Data collected during this test will be analyzed alongside other study variables to understand the relationships between performance metrics and the diagnosis of the condition described.

  Through study completion, an average of 2 years".

Study Arms (1)

Participant with Iliac external endofibrosis disease

Participant will be recruited and information about his training and test in diagnosis process will be analysed.

Diagnostic Test: None-placebo

Interventions

None-placebo DIAGNOSTIC_TEST

Not be displayed, only retrospective data will be required

Participant with Iliac external endofibrosis disease

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with the presence of external iliac artery endofibrosis pathophysiology, detected through performance-related suspicion, diagnosed, undergoing treatment, and in recovery

You may qualify if:

• Clinical diagnosis of external iliac artery endofibrosis confirmed by medical imaging (e.g., Doppler ultrasound, CT scan, or IVUS).
• Age between 18 and 65 years.
• Must be a regular cyclist (at least 500 training sessions per year for the past 5 years).
• Ability to complete physical performance tests (e.g., cycling power output measurements, Lactate Threshold test).
• No prior surgical intervention for external iliac artery endofibrosis or other lower extremity diseases
• Willingness to provide informed consent and participate in the study.

You may not qualify if:

• History of major cardiovascular disease (e.g., heart attack, stroke).
• Pregnancy or breastfeeding.
• Use of medications that significantly affect vascular health (e.g., anticoagulants, steroids).
• Uncontrolled diabetes or other chronic metabolic disorders.
• Recent lower extremity surgery (within the last 6 months).
• Any condition that could interfere with the performance tests (e.g., neurological disorders, severe joint pain).
• Diagnosis of other vascular diseases (e.g., deep vein thrombosis, atherosclerosis) that could affect arterial function.
• History of systemic or local infections that may impact the vascular system.
• History of significant trauma or injury to the lower extremities (e.g., fractures, ligament tears).
• Any condition preventing safe participation in physical tests, including severe cardiovascular or musculoskeletal limitations.

Sponsors & Collaborators

• Jesus Torres: lead

Study Sites (1)

C San Bartolome 4

Estella-Lizarra, Navarre, 31292, Spain

Location

Related Publications (1)

• Mansour A, Murney S, Jordan K, Laperna L. Endofibrosis: an unusual cause of leg pain in an athlete. J Sports Med Phys Fitness. 2016 Jan-Feb;56(1-2):157-61. Epub 2015 Jul 3.

  PMID: 26140352 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Jesús Torres-Pérez: BsC, MD.

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: September 26, 2025
• Study Start: August 1, 2025
• Primary Completion: November 1, 2025
• Study Completion (Estimated): September 30, 2027
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)