Second Line Endovascular Treatment in Acute DVT

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Rush University Medical Center
Study ID
NCT06486181
Phase
PHASE4
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Deep Venous Thrombosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Thrombolysis/Thrombectomy — OTHER
    Endovascular interventions will be either catheter directed thrombolysis or mechanical thrombectomy procedures both of which have been cleared by FDA for the treatment of acute DVT. Catheter-directed thrombolysis involves the use of a catheter to deliver thrombolytic agents directly to the site of the clot, effectively dissolving the thrombus. Mechanical thrombectomy, on the other hand, employs specialized devices to physically remove the clot from the vessel. These procedures have been cleared by FDA as they are targeted approaches to safely and effectively restore blood flow and reduce the risk of complications associated with acute DVT.

Study Details

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.

Key Dates

Start date
Apr 1, 2026
Status verified
Jan 2026
Primary completion
Apr 30, 2028
Completion
Apr 30, 2029

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Unresolved Deep Venous Thrombosis Patients continuing with systemic anticoagulation
    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.
  • Experimental: Unresolved Deep Venous Thrombosis Patients managed by interventional therapies.
    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.

Primary Outcome Measure

Efficacy of Endovascular Treatments Clinically [ Time Frame: 30 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
RUSH University Medical CenterChicagoIllinois60612
Okan Ince, MD
[email protected]
312-947-2508
Emerald Amos, MS
[email protected]
312-947-2518
Bulent Arslan, MD (PRINCIPAL_INVESTIGATOR)
Lisa Rauschert, MD (SUB_INVESTIGATOR)
Rehan Riaz, MD (SUB_INVESTIGATOR)

Find similar trials in Chicago, IL

By research site
RUSH University Medical Center· Chicago, IL

Related Studies