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Postthrombotic Syndrome clinical trials

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NCT ID: NCT06451484 Recruiting - Clinical trials for Lower Limb Venous Thrombosis

Grade Analysis of Veins by MRI and CT in Post-Thrombotic Syndrome

GrAVITSPT
Start date: June 2024
Phase:
Study type: Observational

The aim is to improve the diagnosis of chronic lower limb venous thrombosis before a lower limb venous recanalization procedure. Additionally, if the MRI scores are comparable to those of the CT, MRI would reduce radiation exposure and limit the need for foot vein punctures that accompany CT use.

NCT ID: NCT06385353 Recruiting - Clinical trials for Postthrombotic Syndrome

DVT Burden and the Risk of Post-thrombotic Syndrome

DVT-Burden
Start date: June 5, 2024
Phase: N/A
Study type: Interventional

Post-thrombotic syndrome (PTS) is the most common chronic complication of deep vein thrombosis (DVT), with major consequences for patient quality of life and cost of management. Identifying patients at high risk of developing PTS could be useful for its prevention and may lead to more appropriate therapeutic strategies to reduce its incidence and severity. Prognostic tools for predicting risk are very useful for choosing the optimum treatment and improving patient management and are a preliminary step before developing predictive models useful for determining sensitivity to treatment. At present, although several prognostic markers and models have been proposed, it is still difficult to predict who will develop a PTS or a moderate to severe PTS. The development of PTS is multifactorial and depends largely on the extent and severity of venous obstruction which supports the theory of thrombosis burden (DVT-Burden) as a potential prognostic marker for PTS. It therefore seems important to study the association between thrombosis burden and the occurrence of PTS. The Venous Volumetric Index or VVI (Ouriel 1999) will be used for quantifying DVT-Burden. The VVI was constructed by calculating the volume from the diameter and length of 14 venous segments from the calf veins to the inferior vena cava. The VVI has been validated for its ability to discriminate between symptomatic and asymptomatic DVT and has shown superior performance to other methods for quantifying DVT. This study aim to assess the performance of baseline DVT-burden estimated by the VVI score on ultrasound for predicting the occurrence and the severity of PTS as assessed by the Villalta scale at 6 months.

NCT ID: NCT06198816 Recruiting - Clinical trials for Post-Thrombotic Syndrome of Both Legs

Inflow Improve for Deep Vein thrombOsis With Ultrasound acceLerated thrombOlysis and Venoplasty

Start date: January 29, 2024
Phase:
Study type: Observational

Aim of the IDOLO study is to investigate clinical efficacy on ultrasound accelerated thrombolysis and venoplasty in patients with post-thrombotic syndrome secondary to chronical femoro-popliteal vein occlusion for previous deep vein Thrombosis (DVT). At San Raffaele Hospital (Vascular Surgery Department) will be enrolled 50 patients with lower extremity deep vein thrombosis (who have failed conservative treatment) objectively diagnosed with imaging ≥ 6 months; prior persistent deep vein Thrombosis (DVT) at enrollment evaluation and moderate-severe post-thrombotic syndrome at time of procedure

NCT ID: NCT06046807 Recruiting - Clinical trials for Post Thrombotic Syndrome

Long-Term Post Thrombotic Syndrome Assessment (CELEST Long Term).

CELEST-LT
Start date: July 24, 2023
Phase:
Study type: Observational

The CELEST Long term is a prospective study, assessing the very long term risk of post thrombotic syndrome (PTS) in patients enrolled in the CELEST double-blind RCT. All patients enrolled in CELEST RCT will benefit from a 7-year follow-up visit conducted over the phone. The primary objective is to assess the proportion of patients with moderate-severe PTS assessed with the patient reported Villalta score and the 2 main secondary objectives are to assess predictors of moderate to severe PTS and the impact of initial compression stockings strength (25mmHg vs. 35mmHg) on the development of moderate-severe PTS. Up to 288 patients may participate. The investigators believe that this study has the potential to significantly improve the knowledge on the epidemiology of burdensome PTS and on the impact of different initial compression stockings strengths on the risk of PTS.

NCT ID: NCT05794932 Recruiting - Venous Thromboses Clinical Trials

Exercise Tolerance After Venous Recanalization for Post-thrombotic Syndrome

ETERecaVSPT
Start date: April 17, 2023
Phase: N/A
Study type: Interventional

Post-thrombotic syndrome (PTS) is the most frequently observed chronic complication of deep vein thrombosis (DVT), with an estimated cumulative incidence of 20-50%. Endovascular venous recanalization with angioplasty and stenting of obstructive lesions is the recommended treatment option to reduce or correct the symptoms of DVT. However, its impact on the physical capacity and breathlessness of patients has not been fully demonstrated. The heterogeneous evidences of clinical improvement is probably related to the presence or absence of collateral veins developed in these patients with proximal venous obstruction (iliac or iliofemoral with or without inferior vena cava involvement), which ensure the cardiac venous return. The aim of this study is to compare changes in maximal oxygen uptake after endovascular venous recanalization in DVT patients and to evaluate the hemodynamic, respiratory and muscular improvement induced by the restoration of venous flow in the occluded segments.

NCT ID: NCT05744843 Recruiting - Clinical trials for Post Thrombotic Syndrome

Structured Exercise Versus Endovascular Reconstruction in Post Thrombotic Syndrome

SEvERe-PTS
Start date: September 5, 2023
Phase: N/A
Study type: Interventional

The goal of this pilot study and randomised control trial is to compare a smartphone-based exercise programme to deep venous stenting in patients with Post Thrombotic Syndrome. The main questions it aims to answer are: - Is exercise as effective as stenting in these patients? - What type of exercise is useful in these patients? - Can exercise be used to improve the results from surgery? Participants will be split into two groups at random. They will complete a smartphone-based exercise programme or have a deep venous stent. They will do the following tests before and after. - Exercise testing - Calf muscle strength and function tests - Ultrasound of the deep veins - Quality of life questionnaires - Clinical assessment of their disease They will be compared to healthy volunteers in the pilot study. Investigators will compare exercise to stenting to see if it improves symptoms in these patients. The pilot study will help decide how many patients are needed and what exercise tests will be used for the Randomised control trial.

NCT ID: NCT05701917 Recruiting - Clinical trials for Venous Thromboembolism

DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis

DEFIANCE
Start date: January 6, 2023
Phase: N/A
Study type: Interventional

This study is a prospective, multicenter, randomized controlled trial of an interventional strategy using the ClotTriever System to achieve and maintain vessel patency (ClotTriever Intervention Arm) versus conservative medical management using anticoagulation therapy alone (Conservative Medical Management Arm) in the treatment of subjects with symptomatic unilateral iliofemoral DVT. The study will collect data on demographics, comorbidities, details from the DVT diagnosis and treatment, and clinical outcomes through the 6-month follow up visit.

NCT ID: NCT05622500 Recruiting - Clinical trials for Chronic Venous Insufficiency

Best Endovenous Treatment, Including STenting, Versus Non-endovenous Treatment in Chronic Proximal Deep Venous Disease

BEST
Start date: September 3, 2022
Phase: N/A
Study type: Interventional

Chronic obstruction of the iliac veins or inferior vena cava can occur as a result of deep vein thrombosis (DVT), or due to extrinsic compression in non-thrombotic iliac vein lesions (NIVLs). This obstruction can manifest as post-thrombotic syndrome (PTS) after DVT or as chronic venous disease (CVD) in NIVL. Despite sparse evidence, rates of venous stenting for PTS and NIVLs are increasing. A pragmatic, observer-blind, multi-centre, randomised-controlled trial for adults with CVD secondary to either PTS or NIVLs randomised to either best endovenous therapy (including venoplasty and deep venous stenting) or standard therapy (compression +/- anticoagulation). Included participants will have chronic venous disease (CEAP classification 3 - 6) secondary to proximal deep venous disease. The primary outcome is severity of venous disease at 6 months as ascertained by the Venous Clinical Severity Score (VCSS).

NCT ID: NCT05296499 Recruiting - Clinical trials for Post Thrombotic Syndrome

EXERT: Exercise Physiology After Thrombosis

Start date: September 20, 2019
Phase:
Study type: Observational

Deep vein thrombosis (DVT) can cause long-term scarring and narrowing of veins. When there is extensive damage to the veins in the legs, groin or abdomen it can affect the way that blood is able to flow back up to the heart. Some patients are left with severe symptoms such as pain, leg swelling and ulcers, and have surgical treatment with nitinol stents to re-open the veins and relieve symptoms. The primary aim of this study is to investigate venous blood flow to the heart during exercise in patients with extensive damage to the veins in the groin and abdomen after DVT, and changes that happen after stenting.

NCT ID: NCT04833764 Recruiting - Clinical trials for Post-thrombotic Syndrome

Mechanisms of Deep Vein Thrombosis (DVT) and Vein Wall Fibrosis

Start date: June 1, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this study is to determine the safety and tolerability or efficacy of adjunctive treatments (including rosuvastatin 20 mg daily) in combination with standard anticoagulation therapy (Factor Xa inhibitors) in patients with lower extremity deep vein thrombosis (DVT). The efficacy of adjunctive treatments to prevent the development of post thrombotic syndrome (PTS) after DVT will be evaluated.