Thrombolysis/Thrombectomy for Deep Vein Thrombosis

Overseen By Okan Ince, MS

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Rush University Medical Center

Must be taking: Anticoagulants

Must not be taking: Antiplatelet therapy

Disqualifiers: High bleeding risk, Cancer, Renal failure, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new treatment options for people with deep vein thrombosis (DVT) in the leg who haven't improved after a week of standard blood-thinning medication. It aims to determine if alternative treatments, such as breaking up clots with a catheter (thrombolysis) or using a device to remove them (thrombectomy), are safe and effective. Participants will be divided into two groups: one will continue with standard treatment, while the other will receive one of the new procedures. Good candidates are those who have had DVT for less than two weeks, are on blood thinners, but still experience significant symptoms. As a Phase 4 trial, this study involves treatments that are already FDA-approved and proven effective, helping to understand how they benefit more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study involves anticoagulation treatment, you may need to continue or adjust your current medications under medical supervision.

What is the safety track record for thrombolysis and thrombectomy treatments?

Research has shown that both catheter-directed thrombolysis (CDT) and mechanical thrombectomy (MT) safely treat deep vein thrombosis (DVT). Studies have found that patients generally tolerate mechanical thrombectomy well, with one study reporting a very low rate of serious device-related issues, at just 0.2%. The ClotTriever device, used in MT, successfully removes clots in over 90% of cases.

Catheter-directed thrombolysis also improves vein health and reduces complications after DVT. While all treatments carry risks, evidence suggests these procedures are safe for most patients. The FDA has approved both CDT and MT for treating acute DVT, further supporting their safety. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the treatments for deep vein thrombosis (DVT) in this trial because they offer new ways to tackle blood clots that don’t resolve with standard anticoagulation therapy, which usually involves blood thinners like warfarin or direct oral anticoagulants (DOACs). Unlike traditional methods, thrombolysis and thrombectomy physically remove or dissolve the clot through minimally invasive procedures. Thrombolysis involves delivering clot-busting drugs directly to the site of the clot, while thrombectomy mechanically removes the clot. These approaches can potentially provide quicker relief and prevent complications by directly targeting the obstruction, offering hope for patients who don’t respond to conventional anticoagulants alone.

What evidence suggests that this trial's treatments could be effective for deep vein thrombosis?

Research has shown that catheter-directed thrombolysis (CDT) and mechanical thrombectomy (MT) can effectively treat deep vein thrombosis (DVT) when standard treatments fail. In this trial, participants in the interventional arm will undergo either CDT or MT procedures. One study found that 88.9% of patients experienced improved blood flow in their affected veins after MT. Another report indicated that MT successfully removed most or all of the blood clot in 86% of cases. These treatments work by directly breaking up the clot, which helps restore normal blood flow more quickly. Overall, evidence suggests that these procedures can be a strong option when regular treatment isn't enough. ^{1 2 5 6 7}

Who Is on the Research Team?

Bulent Arslan, MD

Principal Investigator

Rush University Medical Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I can be treated with blood thinners.

I am over 18 years old.

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

Exclusion Criteria

I am over 75 years old.

I am under 18 years old.

My symptoms started over two weeks ago.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Initial Anticoagulation Treatment

Participants receive initial anticoagulation treatment and are assessed for response

1 week

1 visit (in-person)

Randomization and Treatment

Participants are randomized into control or intervention arms. Intervention arm undergoes CDT or MT procedures.

15 days

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Thrombolysis/Thrombectomy

Trial Overview

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.

How Is the Trial Designed?

Group I: Unresolved Deep Venous Thrombosis Patients managed by interventional therapies. Experimental Treatment 1 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 anticoagulation Active Control 1 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 control arm the treatment will be the continuation of current anticoagulation treatment, which is standard of care for 12 months unless crossover between groups is needed.

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

Published Research Related to This Trial

In a study of 28 patients with ischemic stroke undergoing endovascular thrombectomy, the procedure appeared to be safe for those on non-vitamin K antagonist oral anticoagulants, with only 1 patient experiencing symptomatic intracranial hemorrhage despite a 46% rate of any intracranial hemorrhage.

Successful reperfusion was achieved in 59% of cases, and at 3 months, 19% of patients had a favorable functional outcome, indicating that thrombectomy can be effective in this patient population, although further research with larger cohorts is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Endovascular Thrombectomy in Patients Receiving Non-Vitamin K Antagonist Oral Anticoagulants. Purrucker, JC., Wolf, M., Haas, K., et al.[2022]

Aspiration thrombectomy using 9F or 10F catheters for acute lower extremity deep vein thrombosis (DVT) was found to be safe and effective, with a 100% clinical success rate and no procedure-related complications in a study of 68 patients.

The procedure resulted in significant symptom improvement and high patency rates at one year, with primary and secondary patency rates of 89.1% and 96.9%, respectively, indicating long-term effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aspiration thrombectomy using a large-size catheter for acute lower extremity deep vein thrombosis. Jia, Z., Tu, J., Zhao, J., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10615929/

Six-Month Outcomes of Mechanical Thrombectomy for ...

Second, thrombectomy was effective, with excellent Marder score improvements immediately and 88.9% of limbs demonstrating venous patency at 6 ...

2.

jscai.org

jscai.org/article/S2772-9303(24)01372-3/fulltext

Outcomes From Mechanical Thrombectomy for Deep Vein ...

These results suggest that all MT interventions may be unequal in terms of outcomes and resources, with the CT device associated with lower in-hospital ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S277268782500008X

Initial experience and early outcomes of treatment ...

Native vein thrombectomy was successfully achieved in all cases using a Triever catheter in 90 % (9/10) of cases and a ClotTriever device in 40 % (4/10) of ...

4.

jvsvenous.org

jvsvenous.org/article/S2213-333X(22)00094-4/pdf

Interim outcomes of mechanical thrombectomy for deep ...

No patients received thrombolytics and 99.6% were treated in a single ses- sion. Complete or near-complete ($75%) thrombus removal was achieved in 86% of limbs.

5.

jscai.org

jscai.org/article/S2772-9303(24)01618-1/fulltext

Comparative Effectiveness of Thrombectomy Devices in ...

The 30-day readmission rate ranged from 10% (AJ) to 14.6% (IN), while multivariate modeling predicted higher odds of readmission in the IN group ...

6.

sciencedirect.com

sciencedirect.com/science/article/pii/S2772930323000121

Safety and Effectiveness of Mechanical Thrombectomy ...

91.2% of limbs had near or complete and 63.8% had complete thrombus removal. ClotTriever is safe with a 0.2% device-related serious adverse event rate.

7.

cvirendovasc.springeropen.com

cvirendovasc.springeropen.com/articles/10.1186/s42155-024-00495-x

Endovascular treatment of lower limb acute DVT

Catheter-directed thrombolysis demonstrates promising results in enhancing venous patency and reducing post-thrombotic syndrome, with careful ...