Contemporary Endovascular Therapies in Treatment of Acute Iliofemoral Deep Vein Thrombosis (NCT03901872) | Clinical Trial Compass
UnknownNot Applicable
Contemporary Endovascular Therapies in Treatment of Acute Iliofemoral Deep Vein Thrombosis
United Kingdom65 participantsStarted 2019-03-29
Plain-language 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).
Who can participate
Age range16 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 diabeti…