NCT04250025

Angioplasty-stenting vs Optimal Medical Treatment on Post-thrombotic Syndrome Reduction

A Prospective Randomized, Open-label, Blind Evaluator, Evaluating the Efficacy of Proximal Venous Angioplasty-stenting vs Optimal Medical Treatment on Post-thrombotic Syndrome Reduction

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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) 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

Interventions

Type	Name	Description
PROCEDURE	60 patients benefit from immediate venous angioplasty stenting plus medical treatment, i.e. elastic compression and anticoagulation	60 patients benefit from immediate venous angioplasty stenting plus medical treatment, i.e. elastic compression and anticoagulation

Timeline

• Start date: 2019-09-01
• Primary completion: 2025-09-01
• Completion: 2025-12-01
• First posted: 2020-01-31
• Last updated: 2023-12-06

Locations

1 site across 1 country: France