Iliac Artery Occlusive DiseaseNCT07194330
External Iliac Artery Endofibrosis in Cycling
An observational study of Iliac Artery Occlusive Disease and Blood Flow Velocity, run by Jesus Torres at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Iliac Artery Occlusive Disease, Blood Flow Velocity, Performance
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2025to 30 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Participants with the presence of external iliac artery endofibrosis pathophysiology, detected through performance-related suspicion, diagnosed, undergoing treatment, and in recovery
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: External Iliac Artery Endofibrosis: Performance-Related Suspicion, Diagnosis, Treatment, and Management in a Cyclist
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.
Read the detailed description
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.
- Being tested
- None-placebo
- Keywords
- External Iliac Artery, Endofibrosis, Cycling, Angiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None-placeboDiagnostic test
Not be displayed, only retrospective data will be required
| Study group | Role | What they receive |
|---|---|---|
| Participant with Iliac external endofibrosis disease | Participant will be recruited and information about his training and test in diagnosis process will be analysed. Receives: Diagnostic Test: None-placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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).
Measured: 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."
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 2 years".
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start1 Mar 2025
- Primary completion1 Aug 2026
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iliac Artery Occlusive DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jesus Torres
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jesus Torres, University of the Basque Country (UPV/EHU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07194330
- Sponsor's protocol ID
- M10/2025/304
- Status last verified
- Sep 2026
- First submitted
- 5 Aug 2025
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be made available upon request and following approval by the ethics committee, and will be released in an anonymized form
Publications
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.
PubMed 26140352
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Iliac Artery Endofibrosis: Performance-Related Suspicion, Diagnosis, Treatment, and Management in a Cyclist
- ClinicalTrials.gov ID
- NCT07194330
- Acronym / sponsor ID
- M10/2025/304
- Keywords
- External Iliac Artery, Endofibrosis, Cycling, Angiology
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Jesus TorresUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Aug 2026 (actual)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 26 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participant with Iliac external endofibrosis disease | – | Diagnostic Test: None-placeboParticipant will be recruited and information about his training and test in diagnosis process will be analysed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with the presence of external iliac artery endofibrosis pathophysiology, detected through performance-related suspicion, diagnosed, undergoing treatment, and in recovery
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| None-placeboNot be displayed, only retrospective data will be required | Diagnostic test | Participant with Iliac external endofibrosis disease |
Primary outcome
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).
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.
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).
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."
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Background: PubMed 26140352Mansour 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.
- Individual participant dataSharing planned: No. Data will be made available upon request and following approval by the ethics committee, and will be released in an anonymized form
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iliac Artery Occlusive Disease and Blood Flow Velocity, run by Jesus Torres at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eco-Doppler with colour (time frame: 12 months pre-intervention/procedure/surgery; 12 months post-intervention/procedure/surgery.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07194330, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.