Post Thrombotic SyndromeETERecaVSPTNCT05794932
Exercise Tolerance After Venous Recanalization for Post-thrombotic Syndrome
A study testing Stress test in people with Post Thrombotic Syndrome and Venous Thromboses, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Post-thrombotic syndrome (PTS) is the most frequently observed chronic complication of deep vein thrombosis (DVT), with an estimated cumulative incidence of 20-50%. Endovascular venous recanalization with angioplasty and stenting of obstructive lesions is the recommended treatment option to reduce or correct the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Thrombotic Syndrome, Venous Thromboses, Claudication, Intermittent
- What is being tested?
- Stress test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- 17 Apr 2023to 15 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient eligible for endovascular treatment for post-thrombotic syndrome in a chronic context (6 months after the occurrence of thrombosis, without time limit), after validation of the indication during a monthly medical-radiological PCR (St Eloi vascular medicine team and vascular radiologist performing the endovascular treatment)
- Age >= 18 years
Who cannot join
- Contraindication to the performance of a maximal effort test on a cyclo-ergometer
- Refusal of consent after information
- Adult protected by law (guardianship, curatorship)
- Pregnant or breastfeeding woman
- Patient not affiliated to a social security system or not benefiting from such a system
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exercise Tolerance After Venous Recanalization for Post-thrombotic Syndrome: ETERecaVSPT
Post-thrombotic syndrome (PTS) is the most frequently observed chronic complication of deep vein thrombosis (DVT), with an estimated cumulative incidence of 20-50%. Endovascular venous recanalization with angioplasty and stenting of obstructive lesions is the recommended treatment option to reduce or correct the symptoms of DVT. However, its impact on the physical capacity and breathlessness of patients has not been fully demonstrated. The heterogeneous evidences of clinical improvement is probably related to the presence or absence of collateral veins developed in these patients with proximal venous obstruction (iliac or iliofemoral with or without inferior vena cava involvement), which ensure the cardiac venous return. The aim of this study is to compare changes in maximal oxygen uptake after endovascular venous recanalization in DVT patients and to evaluate the hemodynamic, respiratory and muscular improvement induced by the restoration of venous flow in the occluded segments.
- Being tested
- Stress test
- Keywords
- iliac vein, inferior vena cava, exercice tolerance, cardio-pulmonary exercice testing, muscle physiological testing
- Medical subject headings
- Postthrombotic Syndrome, Venous Thrombosis, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress testDiagnostic test
Diagnostic Test:
- Maximum effort test (CPET) on a cycloergometer
- Leg muscle strength assessment
- Leg muscle mass, composition and water compartments (segmental bioelectrical impedance)
- Spirometry, arterial blood gaz, NO/CO transfer
| Study group | Role | What they receive |
|---|---|---|
| Stress test | Experimental | All patients will undergo a stress test before and after venous recanalization. Receives: Diagnostic Test: Stress test |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2 max
Change in VO₂ max is the maximum (max) rate (V) of oxygen (O₂) the body is able to use during exercise from baseline to 8 weeks. It is measured in liters of O2 per minute
Measured: From baseline and 8 weeks
Secondary outcomes (8)
Maximum aerobic power (in Watts)
Maximum aerobic power is measured in watts before and after venous recanalization
Measured: From baseline and 8 weeks
Isowork power
The isowork power is the power output assessed at the V'O2max before recanalization
Measured: From baseline and 8 weeks
Maximal exercise cardiac output (in litres per minute)
Maximal exercise cardiac output is the cardiac output assessed by thoracic impedance et peak exercise before and after venous recanalization
Measured: From baseline and 8 weeks
Exercise change in Inspiratory capacity (in litres)
Exercise change in Inspiratory capacity is the change between rest and peak exercise of the inspiratory capacity (the volume between end-expiratory volume and total lung capacity) before and after venous recanalization
Measured: From baseline and 8 weeks
Maximal exercise capillary volume (in millilitres)
Maximal exercise capillary volume is the capillary volume at peak exercise assessed by NO/CO transfer before and after venous recanalization
Measured: From baseline and 8 weeks
Maximal exercise O2 arterial pressure (PaO2, in mmHg)
Maximal exercise O2 arterial pressure is the oxygen partial pressure in the arterial blood, assessed at peak exercise, before and after venous recanalization
Measured: From baseline and 8 weeks
Maximal isometric torque during leg extension (in Newton.meters)
Maximal isometric strength during leg extension is the maximal torque of the leg extension at 90° knee flexion assessed by a torque sensor before and after venous recanalization
Measured: From baseline and 8 weeks
Lower limb extracellular/total water (in %)
Lower limb extracellular/total water is the water volume int the body compartments in each lower limb, assessed by a segmental bioelectrical impedancemeter before and after venous recanalization
Measured: From baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start17 Apr 2023
- Primary completion15 May 2025
- Study completion15 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Thrombotic SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05794932
- Sponsor's protocol ID
- RECHMPL22_0560
- Acronym
- ETERecaVSPT
- Status last verified
- May 2025
- First submitted
- 17 Mar 2023
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Tolerance After Venous Recanalization for Post-thrombotic Syndrome: ETERecaVSPT
- ClinicalTrials.gov ID
- NCT05794932
- Acronym / sponsor ID
- ETERecaVSPT / RECHMPL22_0560
- Keywords
- iliac vein, inferior vena cava, exercice tolerance, cardio-pulmonary exercice testing, muscle physiological testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 3 Apr 2023 (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.
Post-thrombotic syndrome (PTS) is the most frequently observed chronic complication of deep vein thrombosis (DVT), with an estimated cumulative incidence of 20-50%. Endovascular venous recanalization with angioplasty and stenting of obstructive lesions is the recommended treatment option to reduce or correct the symptoms of DVT. However, its impact on the physical capacity and breathlessness of patients has not been fully demonstrated. The heterogeneous evidences of clinical improvement is probably related to the presence or absence of collateral veins developed in these patients with proximal venous obstruction (iliac or iliofemoral with or without inferior vena cava involvement), which ensure the cardiac venous return. The aim of this study is to compare changes in maximal oxygen uptake after endovascular venous recanalization in DVT patients and to evaluate the hemodynamic, respiratory and muscular improvement induced by the restoration of venous flow in the occluded segments.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stress test | Experimental | Diagnostic Test: Stress testAll patients will undergo a stress test before and after venous recanalization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient eligible for endovascular treatment for post-thrombotic syndrome in a chronic context (6 months after the occurrence of thrombosis, without time limit), after validation of the indication during a monthly medical-radiological PCR (St Eloi vascular medicine team and vascular radiologist performing the endovascular treatment)
- Age >= 18 years
Key exclusion criteria (5 listed)
- Contraindication to the performance of a maximal effort test on a cyclo-ergometer
- Refusal of consent after information
- Adult protected by law (guardianship, curatorship)
- Pregnant or breastfeeding woman
- Patient not affiliated to a social security system or not benefiting from such a system
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 |
|---|---|---|
| Stress testDiagnostic Test: * Maximum effort test (CPET) on a cycloergometer * Leg muscle strength assessment * Leg muscle mass, composition and water compartments (segmental bioelectrical impedance) * Spirometry, arterial blood gaz, NO/CO transfer | Diagnostic test | Stress test |
Primary outcome
VO2 max
Time frame: From baseline and 8 weeks
Change in VO₂ max is the maximum (max) rate (V) of oxygen (O₂) the body is able to use during exercise from baseline to 8 weeks. It is measured in liters of O2 per minute
8 secondary outcomes
Maximum aerobic power (in Watts)
Time frame: From baseline and 8 weeks
Isowork power
Time frame: From baseline and 8 weeks
Maximal exercise cardiac output (in litres per minute)
Time frame: From baseline and 8 weeks
Exercise change in Inspiratory capacity (in litres)
Time frame: From baseline and 8 weeks
Maximal exercise capillary volume (in millilitres)
Time frame: From baseline and 8 weeks
Maximal exercise O2 arterial pressure (PaO2, in mmHg)
Time frame: From baseline and 8 weeks
Maximal isometric torque during leg extension (in Newton.meters)
Time frame: From baseline and 8 weeks
Lower limb extracellular/total water (in %)
Time frame: From baseline and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Individual participant dataSharing planned: No
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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?
A study testing Stress test in people with Post Thrombotic Syndrome and Venous Thromboses, run by University Hospital, Montpellier at 1 site in France.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 30 May 2025. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
VO2 max (time frame: From baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 May 2025.