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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04250025
Recruitment Status : Active, not recruiting
First Posted : January 31, 2020
Last Update Posted : January 31, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

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

Condition or disease Intervention/treatment Phase
Post Thrombotic Syndrome Procedure: 60 patients benefit from immediate venous angioplasty stenting plus medical treatment, i.e. elastic compression and anticoagulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized, Open-label, Blind Evaluator, Evaluating the Efficacy of Proximal Venous Angioplasty-stenting vs Optimal Medical Treatment on Post-thrombotic Syndrome Reduction
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty

Arm Intervention/treatment
Experimental: EXPERIMENTAL GROUPE
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
60 patients benefit from immediate venous angioplasty stenting plus medical treatment, i.e. elastic compression and anticoagulation

No Intervention: CONTRO GROUPE
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.



Primary Outcome Measures :
  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. [ 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04250025


Locations
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France
Grenoble-Alps University Hospital (CHUGA)
Grenoble, Cs 10217, France, 38043
Sponsors and Collaborators
University Hospital, Grenoble
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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT04250025    
Other Study ID Numbers: 2019-A01311-56
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: January 31, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Postthrombotic Syndrome
Postphlebitic Syndrome
Syndrome
Disease
Pathologic Processes
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Venous Insufficiency
Phlebitis
Peripheral Vascular Diseases