Clinical Trials Logo

Clinical Trial Summary

The goal of this initial proof of principle single arm cohort trial is to determine if contemporary endovascular venous intervention, compared with a 1:1 propensity-matched medical therapy arm of the ATTRACT trial, significantly reduces the 2-year occurrence of Post Thrombotic Syndrome (PTS) in subjects with symptomatic proximal Deep Vein Thrombosis (DVT).


Clinical Trial Description

A single arm cohort will serve as a proof of principle study, and be the foundation for a larger subsequent prospective, Randomised Clinical Trial (RCT). The aim of this initial single arm cohort is to both validate that contemporary catheter directed therapy performed by experienced operators has significant efficacy and safety at 10 days, 30 days, 6 months, 12 months, and 2 years (details below). If a strong signal of efficacy and safety is found in the initial single arm cohort at 30 days and 6 months, this will provide objective evidence to move forward with a larger multicentre, prospective, RCT.

If the results of the initial single arm proof of principle cohort do not show efficacy, or there is a safety issue, a larger prospective, RCT will not be performed. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03901872
Study type Observational
Source Guy's and St Thomas' NHS Foundation Trust
Contact Audrey Hau
Phone 02071887188
Email audrey.hau@gstt.nhs.uk
Status Recruiting
Phase
Start date March 29, 2019
Completion date February 2023

See also
  Status Clinical Trial Phase
Recruiting NCT05003843 - BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein Thrombosis N/A
Recruiting NCT03937947 - Traumatic Brain Injury Associated Radiological DVT Incidence and Significance Study
Withdrawn NCT04136561 - Novel Strategy to Encourage Early Removal of Central Venous Catheters N/A
Completed NCT03420625 - Blood Flow Stimulation in the Lower Limbs by Application of Different External Devices N/A
Recruiting NCT02507180 - Safely Ruling Out Deep Vein Thrombosis in Pregnancy With the LEFt Clinical Decision Rule and D-Dimer
Completed NCT02555111 - Xarelto Versus no Treatment for the Prevention of Recurrent Thrombosis in Patients With Chronic Portal Vein Thrombosis. Phase 3
Completed NCT01975090 - The SENTRY Clinical Study N/A
Terminated NCT02469376 - Evaluation of a New Imagingtechnologie for Thrombosis Phase 1
Completed NCT02037607 - Incidence of Venous Thromboembolism in Children Undergoing Elective Neurosurgical Procedures N/A
Not yet recruiting NCT01357941 - Need for Antepartum Thromboprophylaxis in Pregnant Women With One Prior Episode of Venous Thromboembolism (VTE) N/A
Completed NCT00720915 - D-dimer to Select Patients With First Unprovoked Venous Thromboembolism Who Can Have Anticoagulants Stopped at 3 Months N/A
Completed NCT00771303 - Ruling Out Pulmonary Embolism During Pregnancy:a Multicenter Outcome Study
Completed NCT00773448 - Screening for Occult Malignancy in Patients With Idiopathic Venous Thromboembolism N/A
Completed NCT00244725 - Odiparcil For The Prevention Of Venous Thromboembolism Phase 2
Completed NCT00264277 - D-dimer to Establish Duration of Anticoagulation After Venous Thromboembolism Phase 4
Completed NCT00365950 - 3 Months' Versus 6 Months' Anticoagulation in Patients With DVT and/or PE Phase 4
Completed NCT00182403 - Fixed Dose Heparin Study Phase 3
Completed NCT03682419 - Evaluation of Precision and Accuracy of INR Measurements in a Point of Care Device (OPTIMAL) N/A
Not yet recruiting NCT04981327 - The API-CALF Study: Apixaban to Treat Calf Vein Thrombosis Phase 3
Recruiting NCT03240120 - A Study of Dabigatran Etexilate as Primary Treatment of Malignancy Associated Venous Thromboembolism Phase 3