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

100 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Thrombolysis/Thrombectomy for Deep Vein Thrombosis?

Research shows that using catheter-directed thrombolysis (a method to dissolve blood clots) combined with thrombectomy (removal of clots) can be effective for treating deep vein thrombosis in the legs. Studies comparing these methods to other treatments like anticoagulation (blood thinners) suggest they can be beneficial in managing symptoms and improving outcomes. ^{1 2 3 4 5}

Is thrombolysis/thrombectomy generally safe for humans?

Thrombolysis can have significant risks, including major bleeding complications like intracranial bleeding, which can be serious and affect patient outcomes. In a study of patients with cerebral vein thrombosis, 9.8% experienced major bleeding, and 7.6% had intracranial hemorrhages, some of which were fatal. ^{6 7 8 9 10}

How does the treatment of thrombolysis/thrombectomy for deep vein thrombosis differ from other treatments?

Thrombolysis and thrombectomy for deep vein thrombosis (DVT) are unique because they involve directly breaking down and removing blood clots from the veins, often using a catheter (a thin tube) to deliver medication or perform the procedure. This approach is different from traditional treatments like anticoagulation, which only prevent new clots from forming, and can help prevent complications like post-thrombotic syndrome, which can cause long-term leg pain and swelling. ^{1 3 4 11 12}

What is the purpose of 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.

Research Team

Bulent Arslan, MD

Principal Investigator

Rush University Medical Center

Eligibility Criteria

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 under 18 years old.

My symptoms started over two weeks ago.

I am over 75 years old.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Korea (South) pubmed.ncbi.nlm.nih.gov

Catheter-directed thrombolysis with conventional aspiration thrombectomy for lower extremity deep vein thrombosis. [2021]

2. China pubmed.ncbi.nlm.nih.gov

[Outcome comparisons of anticoagulation, systematic thrombolysis and catheter-directed thrombolysis in the treatment of lower extremity acute deep venous thrombosis]. [2013]

3. China pubmed.ncbi.nlm.nih.gov

[Efficacy comparison of interventional thrombectomy versus thrombolysis in the treatment of acute mixed-type lower extremity deep venous thrombosis]. [2013]

4. United States pubmed.ncbi.nlm.nih.gov

Catheter-directed thrombolysis and/or thrombectomy with selective endovascular stenting as alternatives to systemic anticoagulation for treatment of acute deep vein thrombosis. [2022]

5. China pubmed.ncbi.nlm.nih.gov

[Comparison of surgical thrombectomy and interventional thrombectomy for acute deep vein thrombosis of the lower extremity]. [2010]

6. United States pubmed.ncbi.nlm.nih.gov

Early computed tomographic findings for thrombolytic therapy in patients with acute brain embolism. [2019]

7. Germany pubmed.ncbi.nlm.nih.gov

Safety of thrombolysis in cerebral venous thrombosis. A systematic review of the literature. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Safety of Endovascular Thrombectomy in Patients Receiving Non-Vitamin K Antagonist Oral Anticoagulants. [2022]

9. China pubmed.ncbi.nlm.nih.gov

[Comparison of thrombolysis and anticoagulation in pulmonary thromboembolism: a meta-analysis]. [2007]

10. United States pubmed.ncbi.nlm.nih.gov

Aspiration thrombectomy using a large-size catheter for acute lower extremity deep vein thrombosis. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Advances in deep vein thrombosis management with thrombolysis. [2011]

12. United States pubmed.ncbi.nlm.nih.gov

Deep vein thrombosis: endovascular management. [2011]