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Thrombolysis/Thrombectomy for Deep Vein Thrombosis

Phase 4

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 who have diagnosis of acute femoropopliteal acute deep venous thrombus

Be older than 18 years old

Must not have

Patients under 18 years of age

Patients over 75 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

No Placebo-Only Group

Summary

This trial aims to study the effectiveness and safety of using catheter-directed thrombolysis (CDT) and mechanical thrombectomy (MT) as additional treatments for patients with deep vein thrombosis

Who is the study for?

This trial is for patients with acute deep vein thrombosis (DVT) who haven't improved after a week of anticoagulation treatment. Participants will be assessed and, if eligible, can join the study in an office or hospital setting.

What is being tested?

The study tests whether catheter-directed thrombolysis (CDT) and mechanical thrombectomy (MT), as second-line treatments for DVT, are safe and effective. Patients will be randomly assigned to either continue current care or receive these interventions.

What are the potential side effects?

Potential side effects may include bleeding complications due to the invasive nature of CDT and MT, pain at the intervention site, infection risk from catheters used during procedures, and possible damage to blood vessels.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with a deep vein clot in my thigh or knee area.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 18 years old.

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I am over 75 years old.

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I cannot take blood thinners due to health reasons.

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I have severe swelling, pain, a blue tint to my skin, and cannot feel pulses in one area, suggesting compartment syndrome.

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

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 5Eligibility criteria met