Angioplasty-stenting vs Optimal Medical Treatment on Post-thrombotic Syndrome Reduction (NCT04250025) | Clinical Trial Compass
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Angioplasty-stenting vs Optimal Medical Treatment on Post-thrombotic Syndrome Reduction
France120 participantsStarted 2019-09-01
Plain-language 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. 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
* 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,…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.