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OpenTrials
Active, Not Recruiting

NCT Number: NCT07194330

External Iliac Artery Endofibrosis in Cycling

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Iliac Artery Occlusive Disease Blood Flow Velocity Cycling Performance

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

C San Bartolome 4

Estella-Lizarra, Navarre, 31292, Spain

About this study

The medical tests include those performed during the diagnostic process of the pathophysiology of external iliac artery endofibrosis: imaging tests (Doppler ultrasound), exercise stress tests, computed tomography (CT) imaging, and intravascular ultrasound (IVUS). Data collection will be carried out prior to analysis and processing of the results; all data will be anonymized.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

None-placebo

Diagnostic Test

Not be displayed, only retrospective data will be required

Primary outcomes

  1. Eco-Doppler with colour

    Time frame: 12 months pre-intervention/procedure/surgery; 12 months post-intervention/procedure/surgery.

    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).

  2. Performance data in training and competition

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

    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. Distal systolic and dyastolic pressure

    Time frame: 12 months pre-intervention/procedure/surgery; 12 months post-intervention/procedure/surgery.

    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).

  4. Angiography

    Time frame: 12 months pre-intervention/procedure/surgery

    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."

  5. Outcomes during surgery

    Time frame: Perioperative/Periprocedural

    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.

  6. Lactate thresholds test

    Time frame: Through study completion, an average of 2 years".

    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.

Sponsors and collaborators

Lead sponsor

Jesus Torres

Other

Registry information

Official study title

External Iliac Artery Endofibrosis: Performance-Related Suspicion, Diagnosis, Treatment, and Management in a Cyclist

Important dates

Study start
2025
Primary completion
2025
Study completion
2027
First posted
Sep 26, 2025
Registry last updated
Sep 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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