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Unresolved Deep Venous Thrombosis Patients managed by interventional therapies. for Deep Vein Thrombosis

N/A

Waitlist Available

Led By Bulent Arslan, MD

Research Sponsored by Rush University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* Patients over 18 years of age

* Patients who have diagnosis of acute femoropopliteal acute deep venous thrombus

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

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.

Eligible Conditions

Deep Vein Thrombosis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Efficacy of Endovascular Treatments Clinically

Efficacy of Endovascular Treatments Sonographically

Secondary study objectives

Safety of Endovascular Treatments

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Unresolved Deep Venous Thrombosis Patients managed by interventional therapies.Experimental Treatment1 Intervention

Patients presenting to emergency department with the following criteria: over 18 years of age, who have diagnosis of acute femoropopliteal acute deep venous thrombus, placed on anticoagulation treatment and failed to resolve the DVT in 1 week (+/- 3 days) follow up Doppler US study. In intervention arm, patients will undergo either CDT or MT procedures both of which have been cleared by FDA for the treatment of acute DVT. FDA-cleared endovascular devices currently available at our institution will be used for both procedures. The choice of procedure will be based on operator's preference, availability of device and the patient's bleeding risk. The endovascular procedure will be scheduled within 15 days of the initial symptoms.

Group II: Unresolved Deep Venous Thrombosis Patients continuing with systemic anticoagulationActive Control1 Intervention

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rush University Medical CenterLead Sponsor

431 Previous Clinical Trials

158,301 Total Patients Enrolled

Bulent Arslan, MDPrincipal InvestigatorRush University Medical Center

1 Previous Clinical Trials

113 Total Patients Enrolled

~67 spots leftby Jun 2025

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