Second Line Endovascular Treatment in Acute DVT
ConditionDeep Venous Thrombosis
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRush University Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients over 18 years of age
Patients who have diagnosis of acute femoropopliteal acute deep venous thrombus
Patients eligible for anticoagulation treatment
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Thrombolysis/Thrombectomy
Other interventionEndovascular 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Unresolved Deep Venous Thrombosis Patients continuing with systemic anticoagulationNo intervention 0 interventions
Group B: Unresolved Deep Venous Thrombosis Patients managed by interventional therapies.Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Efficacy of Endovascular Treatments Clinically
The clinical symptoms will be evaluated to assess the efficacy of treatments treatment with Villalta score which ranges from 0 to 33 where higher score is the more severe disease The scores will be compared between arms at the end of the study.
Time frame
30 days2
Efficacy of Endovascular Treatments Clinically
The clinical symptoms will be evaluated to assess the efficacy of treatments treatment with Villalta score which ranges from 0 to 33 where higher score is the more severe disease The scores will be compared between arms at the end of the study.
Time frame
90 days3
Efficacy of Endovascular Treatments Clinically
The clinical symptoms will be evaluated to assess the efficacy of treatments treatment with Villalta score which ranges from 0 to 33 where higher score is the more severe disease The scores will be compared between arms at the end of the study.
Time frame
180 days4
Efficacy of Endovascular Treatments Clinically
The clinical symptoms will be evaluated to assess the efficacy of treatments treatment with Villalta score which ranges from 0 to 33 where higher score is the more severe disease The scores will be compared between arms at the end of the study.
Time frame
12 monthsSecondary outcomes
1
Safety of Endovascular Treatments
Any adverse events occurred within 30 days of procedure will be reviewed and categorized by the current Society of Interventional Radiology guidelines.
Time frame
30 daysSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: