Post Thrombotic SyndromeEndoPTSNCT04250025
Angioplasty-stenting vs Optimal Medical Treatment on Post-thrombotic Syndrome Reduction
A study testing 60 patients benefit from immediate venous angioplasty stenting plus medical treatment, i.e. elastic compression and anticoagulation in people with Post Thrombotic Syndrome, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The project will highlight the potential benefit of endovascular therapy on post thrombotic syndrome reduction after proximal iliac DVT. There is actually not real standard of care for the treatment of this pathology. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Thrombotic Syndrome
- What is being tested?
- 60 patients benefit from immediate venous angioplasty stenting plus medical treatment, i.e. elastic compression and anticoagulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2019to 1 Dec 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 age ≥ 18 years' old
- Patient with disabling PTS defined as a Villalta score ≥ 10, more than 6 months after unilateral proximal deep vein thrombosis (first or recurrent episode) involving at least iliac vein. A contralateral distal or superficial vein thrombosis was not considered as bilateral thrombosis.
- Rational for main inclusion criteria:
- Patients would be screened more than 6 months after the index DVT event to be sure that symptoms were related to chronic phase of PTS and not to the acute DVT event.
- Although endovascular therapy has actually matured to propose a systematic evaluation, the procedure remains experimental with potential risks. Therefore, the study must focus on patients with advanced PTS and iliofemoral obstruction, since this population appears to have the greatest attempted benefit.
Who cannot join
- Index DVT without iliac thrombosis
- Bilateral proximal deep vein thrombosis or Inferior vena cava thrombosis
- Lower limb arteriopathy defined as ante-brachial index < 0.5
- Vena cava filter
- Venous ulcers ≥ 50 cm²
- Life expectancy < 6 months
Show all 19Show fewer
- Contraindication to anticoagulant treatment by direct oral anticoagulant
- Contraindication to the use of low-dose aspirin (100 mg)
- Use of dual antiplatelet agents aspirin/clopidogrel
- Use of Prasugrel or Ticagrelor
- Previous venous recanalization of the same leg
- Impossible to follow-up
- Contraindication to contrast iodine
- Renal insufficiency (Cockroft <30 ml/min, (less than 3 months old))
- Subject in exclusion period from another study,
- Pregnant or breastfeeding women
- Subject under administrative or judicial control
- Subject under legal protection
- Subject hospitalized for psychiatric care
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Grenoble-Alps University Hospital (CHUGA)
Grenoble, CS 10217, 38043
About this study
Official title: A Prospective Randomized, Open-label, Blind Evaluator, Evaluating the Efficacy of Proximal Venous Angioplasty-stenting vs Optimal Medical Treatment on Post-thrombotic Syndrome Reduction
The project will highlight the potential benefit of endovascular therapy on post thrombotic syndrome reduction after proximal iliac DVT. There is actually not real standard of care for the treatment of this pathology. A clear evidence of efficacy of endovascular therapy will be of great benefit for both the patients and the healthcare system, and will provide new data for further international guidelines
Read the detailed description
Benefit(s) for the individual:
Patients included in the experimental arm of the study will attempt to a strong reduction of PTS. In addition, all patients of the study will benefit from a careful follow-up thanks to the availability of physicians involved in the study, optimization of quality of compression therapy and anticoagulant treatment, and will be strongly encouraged to regular physical activity.
Group(s) Benefits:
About 100 000 to 150 000 persons develop VTE each year in France, among which about 5% will develop severe and disabling PTS. Validation of interventional therapy may provide a major clinical improvement for these patients in terms of morbidity and quality of life. The economic impact is likely to be improved.
Risk(s) to the individual(s)
The first risk is related to interventional treatment, i.e. haemorrhages or early DVT recurrence. The use of endovascular approach will reduce the haemorrhagic risk compared to open surgery, and the risk of recurrence will be controlled by anticoagulant.
The second risk is related to antithrombotic treatment, i.e. combination of aspirin plus anticoagulant, then anticoagulant alone. The combined therapy will be used during a short one-month treatment reducing the risk, and the patients are already trained to anticoagulant treatment. Moreover, it is attempted, regarding the characteristics of patients eligible to interventional procedure that these patients are at low risk of bleeding.
2.3.2 Benefit/risk balance
The benefit/risk balance will be positive.
Patients included in the experimental arm of the study will attempt to a strong reduction of PTS, although the procedure is mastered with limited risk. The fact that investigators already practice this procedure in everyday practice contributes to reducing this risk.
Patients included in the control group will be treated according to the current clinical practice and national and international recommendations. In case of non-resolution of symptoms, they will be invited to interventional procedure 6 months later.
In addition, all patients of the study will benefit from a careful follow-up.
Adverse events will be supervised to control the benefit/risk balance between the two arms. Moreover, the choice to propose a delayed endovascular procedure for control group's patients is primordial because even if the medical treatment is the current clinical practice and national and international recommendations, endovascular procedure has emerged like key treatment. So, to avoid the risk that patients refuse study or leave the study if they are randomized in medical treatment, we propose a 6 months delayed intervention for these patients. This delay of 6 months is reasonable for the adherence of patients to the study.
With these patients, we will have access to results of endovascular procedure at 6 months after delayed intervention, increasing the pool of data on the effect of endovascular procedure.
2.4 Expected Impact
The project will highlight the potential benefit of endovascular therapy on post thrombotic syndrome reduction after proximal iliac DVT. There is actually not real standard of care for the treatment of this pathology. A clear evidence of efficacy of endovascular therapy will be of great benefit for both the patients and the healthcare system, and will provide new data for further international guidelines
- Conditions
- Post Thrombotic Syndrome
- Being tested
- 60 patients benefit from immediate venous angioplasty stenting plus medical treatment, i.e. elastic compression and anticoagulation
- Medical subject headings
- Postthrombotic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
60 patients benefit from immediate venous angioplasty stenting plus medical treatment, i.e. elastic compression and anticoagulationProcedure or surgery
60 patients benefit from immediate venous angioplasty stenting plus medical treatment, i.e. elastic compression and anticoagulation
| Study group | Role | What they receive |
|---|---|---|
| EXPERIMENTAL GROUPE | Experimental | 60 patients benefit from immediate venous angioplasty stenting plus medical treatment, i.e. elastic compression and anticoagulation Receives: Procedure: 60 patients benefit from immediate venous angioplasty stenting plus medical treatment, i.e. elastic compression and anticoagulation |
| CONTRO GROUPE | No intervention | 60 patients benefit from standard treatment for 6 months i.e elastic compression and anticoagulation if needed. Notably, if patients were no longer on anticoagulant treatment at the time of screening and inclusion, this treatment will not be reintroduced. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of percentage of patients with corrected PTS (Villalta< 5 i.e. absence of PTS) at 6 months after randomization in control group and 6 months after intervention in experimental group.
Comparison of percentage of patients with corrected PTS (Villalta< 5 i.e. absence of PTS) at 6 months after randomization in control group and 6 months after intervention in experimental group.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start1 Sep 2019
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Dec 2025 (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 Post Thrombotic SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients are randomised into two groups:Experimental Group: 60 patients benefit from immediate venous angioplasty stenting plus medical treatment, i.e. elastic compression and anticoagulation Control Group: 60 patients benefit from standard treatment for 6 months i.e elastic compression and anticoagulation if needed. Notably, if patients were no longer on anticoagulant treatment at the time of screening and inclusion, this treatment will not be reintroduced.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04250025
- Sponsor's protocol ID
- 2019-A01311-56
- Acronym
- EndoPTS
- Status last verified
- Feb 2023
- First submitted
- 27 Jan 2020
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Flumignan RL, Nakano LC, Flumignan CD, Baptista-Silva JC. Angioplasty or stenting for deep venous thrombosis. Cochrane Database Syst Rev. 2025 Feb 19;2(2):CD011468. doi: 10.1002/14651858.CD011468.pub2.
PubMed 39968829
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized, Open-label, Blind Evaluator, Evaluating the Efficacy of Proximal Venous Angioplasty-stenting vs Optimal Medical Treatment on Post-thrombotic Syndrome Reduction
- ClinicalTrials.gov ID
- NCT04250025
- Acronym / sponsor ID
- EndoPTS / 2019-A01311-56
- Conditions
- Post Thrombotic Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 31 Jan 2020 (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.
The project will highlight the potential benefit of endovascular therapy on post thrombotic syndrome reduction after proximal iliac DVT. There is actually not real standard of care for the treatment of this pathology. A clear evidence of efficacy of endovascular therapy will be of great benefit for both the patients and the healthcare system, and will provide new data for further international guidelines
Detailed description
Benefit(s) for the individual:
Patients included in the experimental arm of the study will attempt to a strong reduction of PTS. In addition, all patients of the study will benefit from a careful follow-up thanks to the availability of physicians involved in the study, optimization of quality of compression therapy and anticoagulant treatment, and will be strongly encouraged to regular physical activity.
Group(s) Benefits:
About 100 000 to 150 000 persons develop VTE each year in France, among which about 5% will develop severe and disabling PTS. Validation of interventional therapy may provide a major clinical improvement for these patients in terms of morbidity and quality of life. The economic impact is likely to be improved.
Risk(s) to the individual(s)
The first risk is related to interventional treatment, i.e. haemorrhages or early DVT recurrence. The use of endovascular approach will reduce the haemorrhagic risk compared to open surgery, and the risk of recurrence will be controlled by anticoagulant.
The second risk is related to antithrombotic treatment, i.e. combination of aspirin plus anticoagulant, then anticoagulant alone. The combined therapy will be used during a short one-month treatment reducing the risk, and the patients are already trained to anticoagulant treatment. Moreover, it is attempted, regarding the characteristics of patients eligible to interventional procedure that these patients are at low risk of bleeding.
2.3.2 Benefit/risk balance
The benefit/risk balance will be positive.
Patients included in the experimental arm of the study will attempt to a strong reduction of PTS, although the procedure is mastered with limited risk. The fact that investigators already practice this procedure in everyday practice contributes to reducing this risk.
Patients included in the control group will be treated according to the current clinical practice and national and international recommendations. In case of non-resolution of symptoms, they will be invited to interventional procedure 6 months later.
In addition, all patients of the study will benefit from a careful follow-up.
Adverse events will be supervised to control the benefit/risk balance between the two arms. Moreover, the choice to propose a delayed endovascular procedure for control group's patients is primordial because even if the medical treatment is the current clinical practice and national and international recommendations, endovascular procedure has emerged like key treatment. So, to avoid the risk that patients refuse study or leave the study if they are randomized in medical treatment, we propose a 6 months delayed intervention for these patients. This delay of 6 months is reasonable for the adherence of patients to the study.
With these patients, we will have access to results of endovascular procedure at 6 months after delayed intervention, increasing the pool of data on the effect of endovascular procedure.
2.4 Expected Impact
The project will highlight the potential benefit of endovascular therapy on post thrombotic syndrome reduction after proximal iliac DVT. There is actually not real standard of care for the treatment of this pathology. A clear evidence of efficacy of endovascular therapy will be of great benefit for both the patients and the healthcare system, and will provide new data for further international guidelines
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients are randomised into two groups:Experimental Group: 60 patients benefit from immediate venous angioplasty stenting plus medical treatment, i.e. elastic compression and anticoagulation Control Group: 60 patients benefit from standard treatment for 6 months i.e elastic compression and anticoagulation if needed. Notably, if patients were no longer on anticoagulant treatment at the time of screening and inclusion, this treatment will not be reintroduced.
| Arm | Type | Receives |
|---|---|---|
| EXPERIMENTAL GROUPE | Experimental | Procedure: 60 patients benefit from immediate venous angioplasty stenting plus medical treatment, i.e. elastic compression and anticoagulation60 patients benefit from immediate venous angioplasty stenting plus medical treatment, i.e. elastic compression and anticoagulation |
| CONTRO GROUPE | No intervention | –60 patients benefit from standard treatment for 6 months i.e elastic compression and anticoagulation if needed. Notably, if patients were no longer on anticoagulant treatment at the time of screening and inclusion, this treatment will not be reintroduced. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient age ≥ 18 years' old
- Patient with disabling PTS defined as a Villalta score ≥ 10, more than 6 months after unilateral proximal deep vein thrombosis (first or recurrent episode) involving at least iliac vein. A contralateral distal or superficial vein thrombosis was not considered as bilateral thrombosis.
- Patients would be screened more than 6 months after the index DVT event to be sure that symptoms were related to chronic phase of PTS and not to the acute DVT event.
- Although endovascular therapy has actually matured to propose a systematic evaluation, the procedure remains experimental with potential risks. Therefore, the study must focus on patients with advanced PTS and iliofemoral obstruction, since this population appears to have the greatest attempted benefit.
Key exclusion criteria (19 listed)
- Index DVT without iliac thrombosis
- Bilateral proximal deep vein thrombosis or Inferior vena cava thrombosis
- Lower limb arteriopathy defined as ante-brachial index < 0.5
- Vena cava filter
- Venous ulcers ≥ 50 cm²
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 |
|---|---|---|
| 60 patients benefit from immediate venous angioplasty stenting plus medical treatment, i.e. elastic compression and anticoagulation60 patients benefit from immediate venous angioplasty stenting plus medical treatment, i.e. elastic compression and anticoagulation | Procedure or surgery | EXPERIMENTAL GROUPE |
Primary outcome
Comparison of percentage of patients with corrected PTS (Villalta< 5 i.e. absence of PTS) at 6 months after randomization in control group and 6 months after intervention in experimental group.
Time frame: 6 months
Comparison of percentage of patients with corrected PTS (Villalta< 5 i.e. absence of PTS) at 6 months after randomization in control group and 6 months after intervention in experimental group.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Derived from this study: PubMed 39968829Flumignan RL, Nakano LC, Flumignan CD, Baptista-Silva JC. Angioplasty or stenting for deep venous thrombosis. Cochrane Database Syst Rev. 2025 Feb 19;2(2):CD011468. doi: 10.1002/14651858.CD011468.pub2.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 60 patients benefit from immediate venous angioplasty stenting plus medical treatment, i.e. elastic compression and anticoagulation in people with Post Thrombotic Syndrome, run by University Hospital, Grenoble 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 5 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 6 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gilles Gilles Pernod, MD PH (00 33 4 76 76 57 17, GPernod@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of percentage of patients with corrected PTS (Villalta< 5 i.e. absence of PTS) at 6 months after randomization in control group and 6 months after intervention in experimental group. (time frame: 6 months). 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 NCT04250025, 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 6 Dec 2023.