Angioplasty-stenting vs Optimal Medical Treatment on Post-thrombotic Syndrome Reduction (NCT04250025) | Clinical Trial Compass
UnknownNot Applicable
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 range18 Years
SexALL
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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,…
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.