Second Line Endovascular Treatment in Acute DVT
NCT Number: NCT06486181
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Deep Venous Thrombosis
Interventions: OTHER: Thrombolysis/Thrombectomy
Sponsor: Rush University Medical Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2026-06-30
Locations: RUSH University Medical Center, Chicago, Illinois, 60612, United States

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.

Primary Outcome Measures: 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., 30 days|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., 90 days|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., 180 days|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., 12 months|Efficacy of Endovascular Treatments Sonographically, The thrombus burden will be evaluated to assess the efficacy of treatments treatment with Marder score which ranges from 0 to 24 where higher scores represent more severe thrombus burden.

The scores will be compared between arms at the end of the study., 30 days|Efficacy of Endovascular Treatments Sonographically, The thrombus burden will be evaluated to assess the efficacy of treatments treatment with Marder score which ranges from 0 to 24 where higher scores represent more severe thrombus burden.

The scores will be compared between arms at the end of the study., 90 days|Efficacy of Endovascular Treatments Sonographically, The thrombus burden will be evaluated to assess the efficacy of treatments treatment with Marder score which ranges from 0 to 24 where higher scores represent more severe thrombus burden.

The scores will be compared between arms at the end of the study., 180 days|Efficacy of Endovascular Treatments Sonographically, The thrombus burden will be evaluated to assess the efficacy of treatments treatment with Marder score which ranges from 0 to 24 where higher scores represent more severe thrombus burden.

The scores will be compared between arms at the end of the study., 12 months
Secondary Outcome Measures: 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., 30 days