Catheter-directed Thrombolysis Compared to Anticoagulation Alone for Acute Primary Iliofemoral De… (NCT04411316) | Clinical Trial Compass
WithdrawnPhase 4
Catheter-directed Thrombolysis Compared to Anticoagulation Alone for Acute Primary Iliofemoral Deep Venous Thrombosis
Stopped: Zero Patients met criteria
United States0Started 2019-12-19
Plain-language summary
Post-thrombotic syndrome (PTS) is a complication that can develop after deep vein thrombosis (DVT) of the lower extremities. PTS can occur at various times after the initial episode, but usually manifests within two years of initial DVT onset. Early and more complete thrombus clearance is believed by many to relieve venous outflow obstruction, preserve valvular function and reduce venous hypertension. Two previously published randomized controlled trials, the CAVENT trial and the ATTRACT trial, were larger and designed to investigate the efficacy of CDT. However, both of these trials included patients with iliofemoral as well as femoro-popliteal deep vein thrombosis. Our study will be limited to patients with iliofemoral deep vein thrombosis to assess whether Pharmacomechanical catheter-directed thrombolysis (PCDT) therapy utilizing AngioJet and tPA can safely and effectively reduce post thrombotic syndrome after 24 months.
Who can participate
Age range18 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
✓. Age\>18 and younger than 75
✓. Symptomatic, proximal deep-vein thrombosis involving the Iliofemoral vein from 12/01/2019 to 12/01/2022
Exclusion criteria
✕. Age less than 18 years or greater than 75 years.
✕. Symptom duration \> 14 days for the DVT episode in the index leg (i.e. non-acute DVT).
✕. 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 popliteal and/or tibial veins; or b) for which thrombolysis is planned as part of initial therapy.
✕. Limb-threatening circulatory compromise.
✕. PE with hemodynamic compromise (i.e. hypotension).
✕. Inability to tolerate PCDT procedure due to severe dyspnea or acute systemic illness.
✕
What they're measuring
1
Post-thrombotic syndrome at any time between 6-month and 24-month.
. Allergy, hypersensitivity, or thrombocytopenia from heparin, rt-PA, or iodinated contrast, except for mild-moderate contrast allergies for which steroid pre-medication can be used.