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

NCT04250025 | Unknown DMC

• 1 other identifier: 2019-A01311-56
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Post Thrombotic Syndrome

Outcome Measures

Primary Outcomes (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.

  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.

  6 months

Study Arms (2)

EXPERIMENTAL GROUPE

EXPERIMENTAL

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

Procedure: 60 patients benefit from immediate venous angioplasty stenting plus medical treatment, i.e. elastic compression and anticoagulation

CONTRO GROUPE

NO INTERVENTION

60 patients benefit from standard treatment for 6 months i.e elastic compression and anticoagulation if needed. Notably, if patients were no longer on anticoagulant treatment at the time of screening and inclusion, this treatment will not be reintroduced.

Interventions

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

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

EXPERIMENTAL GROUPE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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))
• Pregnant or breastfeeding women

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

Grenoble-Alps University Hospital (CHUGA)

Grenoble, CS 10217, 38043, France

RECRUITING

Related Publications (1)

• Flumignan RL, Nakano LC, Flumignan CD, Baptista-Silva JC. Angioplasty or stenting for deep venous thrombosis. Cochrane Database Syst Rev. 2025 Feb 19;2(2):CD011468. doi: 10.1002/14651858.CD011468.pub2.

  PMID: 39968829 DERIVED

MeSH Terms

Conditions

Postthrombotic Syndrome

Condition Hierarchy (Ancestors)

Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Venous Insufficiency

Central Study Contacts

Gilles Gilles Pernod, MD PH

CONTACT

00 33 4 76 76 57 17; GPernod@chu-grenoble.fr

Julien Colombat

CONTACT

00 33 4 76 76 56 09; JColombat@chu-grenoble.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients are randomised into two groups:Experimental Group: 60 patients benefit from immediate venous angioplasty stenting plus medical treatment, i.e. elastic compression and anticoagulation Control Group: 60 patients benefit from standard treatment for 6 months i.e elastic compression and anticoagulation if needed. Notably, if patients were no longer on anticoagulant treatment at the time of screening and inclusion, this treatment will not be reintroduced.

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: January 31, 2020
• Study Start: September 1, 2019
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 6, 2023

Record last verified: 2023-02

Locations

FR (1)