Catheter treatments for deep vein blood clots that did not improve with blood thinners

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with a new blood clot in the deep veins of the thigh and knee area (acute femoropopliteal DVT). It is for people whose clot has not improved after about 1 week of blood thinners.

Age

18 to 75 years

Sex

All sexes

Disease stage

Acute deep vein clot in the femoropopliteal veins (thigh to knee). Symptoms started no more than 14 days ago. A large clot remains after 1 week of treatment.

Earlier treatment

People must be able to take blood thinners (anticoagulation). They must have been on blood thinners for about 1 week without enough improvement.

Biomarker or test result

A repeat ultrasound (Doppler US) at 1 week shows the clot has not cleared.

Main reasons for not taking part

• Symptoms started more than 14 days ago
• Cannot take blood thinners
• High bleeding risk (more than 2 risk factors, such as age >65 years, past bleeding, cancer, kidney or liver failure, low platelets, past stroke, recent surgery in 30 days)
• Unstable blood pressure or circulation
• Severe swelling and pain, bluish skin and no pulse in the leg (compartment syndrome)

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you between 18 and 75 years old?YesNo

What the trial wants to find out

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:

The 2 groups in the trial

• Unresolved Deep Venous Thrombosis Patients continuing with systemic anticoagulationNo study treatment, for comparison

  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.

• Unresolved Deep Venous Thrombosis Patients managed by interventional therapies.Treatment being tested

  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.

  Treatment: Thrombolysis/Thrombectomy