A Prospective Randomized, Open-label, Blind Evaluator, Evaluating the Efficacy of Proximal Venous Angioplasty-stenting vs Optimal Medical Treatment on Post-thrombotic Syndrome Reduction
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- 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.
Study Overview
Brief 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
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)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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, (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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported