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Contemporary Endovascular Therapies in Treatment of Acute Iliofemoral Deep Vein Thrombosis

Contemporary Endovascular Therapies in Treatment of Acute Iliofemoral Deep Vein Thrombosis A Prospective, Multicentre Cohort Trial A Physician Initiated Research Study Request

NCT03901872•Guy's and St Thomas' NHS Foundation Trust

View on ClinicalTrials.gov

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).

Detailed 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.

Eligibility

Age

16 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patient age 16 years to 75 years.
•Onset of acute DVT symptoms of 14 days or less in the study limb.
•DVT located in the common and/or external iliac, or common femoral vein
•Consent to participate in this research study and be willing to commit to study requirements including completion of questionnaires and follow-up visits.

Exclusion Criteria

•In the index leg: established PTS, or previous symptomatic DVT within the last 2 years.
•In the contralateral (non-index) leg: symptomatic acute DVT a) involving the iliac and/or common femoral vein; or b) for which thrombolysis is planned as part of initial therapy.
•Limb-threatening circulatory compromise.
•Pulmonary embolism defined as either massive (Systolic blood pressure \< 90 mmHg and/or patient on IV vasoactive medication to support blood pressure), or intermediate high risk pulmonary embolism (PE), as defined by the European Society Guideline on management of PE. Low risk PE and/or intermediate low risk PE can be enrolled.
•Inability to tolerate contemporary venous intervention procedure due to severe dyspnea or acute systemic illness.
•Allergy, hypersensitivity, or thrombocytopenia from heparin, Recombinant tissue plasminogen activator (rtPA), or iodinated contrast, except for mild-moderate contrast allergies for which steroid pre-medication can be used.
•Haemoglobin \< 9.0 mg/dl, INR \> 1.6 before starting anticoagulation, or platelets \< 100,000/ml. Moderate renal impairment in diabetic patients (estimated glomerular filtration rate \< 60 ml/min) or severe renal impairment in non-diabetic patients (estimated glomerular filtration rate \< 30 ml/min).
•Active bleeding, recent (\< 3 mo) GI bleeding, severe liver dysfunction, bleeding diathesis.
•Recent (\< 3 mo) internal eye surgery or haemorrhagic retinopathy; recent (\< 10 days) major surgery, cataract surgery, trauma, cardiopulmonary resuscitation, obstetrical delivery, or other invasive procedure.
•History of stroke or intracranial/intraspinal bleed, tumor, vascular malformation, aneurysm.
+9 more criteria

Locations (1)

Guy's & St Thomas' NHS Foundation Trust

London, United Kingdom

Key Dates

Start Date

March 29, 2019

Primary Completion Date

February 1, 2023

Completion Date

February 1, 2023

Last Updated

August 2, 2019

Enrollment

ESTIMATED participants

Conditions

ThrombolysisDeep Vein Thrombosis

Interventions

Contemporary endovascular venous intervention by Zelante pharmacomechanical thrombolysis

DEVICE

Contacts

Audrey Hau

CONTACT

02071887188 audrey.hau@gstt.nhs.uk

Stephen Black

CONTACT

02071887188 stephen.black@gstt.nhs.uk

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 2, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Contemporary Endovascular Therapies in Treatment of Acute Iliofemoral Deep Vein Thrombosis

Inclusion Criteria

Exclusion Criteria

Cleaner Long-tErm Assessment Registry - Venous Insights and Efficacy With eXtended Tracking

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