A Randomized Controlled Trial for Second Line Treatment of Acute DVT With Endovascular Interventional Treatments
Rush University Medical Center
Summary
The goal of this study is to fill the paucity of second line endovascular treatment for acute deep venous thrombus (DVT) by using catheter-directed thrombolysis (CDT) and mechanical thrombectomy (MT) as adjunctive second-line treatments for acute DVT patients who show no improvement after an initial anticoagulation trial for one week. The main questions the study aims to answer are: \- Are adjunctive use of endovascular interventional treatments as second-line to DVT treatment safe and efficient? Participants will be followed with repeat US at 1 week after initial DVT to assess for response to anticoagulation treatment. If there is significant residual thrombus with minimal or no response to treatment, participants will be offered enrollment to the study in the office or inpatient setting. Enrolled participants will be randomized into control or intervention arms with 1:1 ratio. Researchers will compare follow-up Villalta and Marder scores between groups to see whether endovascular interventions are safe and efficient.
Description
The incidence of deep vein thrombosis (DVT) annually is documented to be between 45 and 117 cases per 100,000 individuals. The disease markedly impairs patient well-being, leading to symptoms such as pain, limb edema, diminished mobility, and the development of cutaneous ulcers. The spectrum of DVT-associated complications is broad, encompassing post-thrombotic syndrome (PTS) in up to 56% of patients \[1\] , pulmonary embolism (PE) in an estimated 15% to 32%, and a recurrence rate of DVT within one year in approximately 22% of cases \[2\] . Survival metrics for DVT patients indicate a survival…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients over 18 years of age * Patients who have diagnosis of acute femoropopliteal acute deep venous thrombus * Patients eligible for anticoagulation treatment Exclusion Criteria: * Patients under 18 years of age * Patients over 75 years of age * Symptoms starting date of more than 14 days * Patients who have contraindication for anticoagulation treatment * Patients who have high bleeding risk (more than 2 of the following risk factors): * Age \>65 years * Previous bleeding * Cancer * Metastatic cancer * Renal failure * Liver failure * Thrombocytopenia…
Interventions
- OtherThrombolysis/Thrombectomy
Endovascular interventions will be either catheter directed thrombolysis or mechanical thrombectomy procedures both of which have been cleared by FDA for the treatment of acute DVT. Catheter-directed thrombolysis involves the use of a catheter to deliver thrombolytic agents directly to the site of the clot, effectively dissolving the thrombus. Mechanical thrombectomy, on the other hand, employs specialized devices to physically remove the clot from the vessel. These procedures have been cleared by FDA as they are targeted approaches to safely and effectively restore blood flow and reduce the risk of complications associated with acute DVT.
Location
- RUSH University Medical CenterChicago, Illinois