Comparing angioplasty-stenting and medical treatment for post-thrombotic syndrome
A Prospective Randomized, Open-label, Blind Evaluator, Evaluating the Efficacy of Proximal Venous Angioplasty-stenting vs Optimal Medical Treatment on Post-thrombotic Syndrome Reduction
This study is testing if a procedure called angioplasty-stenting can help people with post-thrombotic syndrome feel better compared to just taking medication.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Grenoble Academic / other |
| Locations | 1 site (Grenoble, Cs 10217) |
| Trial ID | NCT04250025 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of endovascular therapy, specifically angioplasty-stenting, in reducing post-thrombotic syndrome (PTS) symptoms in patients who have experienced proximal deep vein thrombosis (DVT). Participants will receive either the interventional treatment combined with medical therapy or optimal medical treatment alone. The study aims to provide clear evidence of the efficacy of this approach, which could lead to improved patient outcomes and inform future clinical guidelines. Patients will also receive comprehensive follow-up care, including optimization of compression therapy and encouragement for physical activity.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with disabling post-thrombotic syndrome defined by a Villalta score of 10 or higher, occurring more than six months after a unilateral proximal DVT.
Not a fit: Patients with bilateral proximal DVT, inferior vena cava thrombosis, or those who do not have iliac vein involvement may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the quality of life for patients suffering from post-thrombotic syndrome.
How similar studies have performed: While the approach of endovascular therapy for PTS is still considered experimental, there is potential for success based on emerging evidence in similar interventions.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Grenoble, Cs 10217
- Grenoble-Alps University Hospital (CHUGA) — Grenoble, Cs 10217, France (Recruiting)
Study contacts
- Study coordinator: Gilles Gilles Pernod, MD PH
- Email: GPernod@chu-grenoble.fr
- Phone: 00 33 4 76 76 57 17
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.