Ultrasound-enhanced Thrombolysis Versus Standard Catheter Directed Thrombolysis for Ilio-femoral Deep Vein Thrombosis

Summary

Patients with deep vein thrombosis (DVT) of the ilio-femoral veins have increased risk for developing post-thrombotic syndrome (PTS) and recurrent venous thromboembolism compared to more distal DVT. There's evidence that the early removal of the obstructing thrombus by catheter directed thrombolysis (CDT) reduces the risk of developing a PTS, and a higher degree of thrombolysis is associated with lower incidence of PTS, better quality of life and lower risk of recurrent venous thromboembolism. A further development is ultrasound-enhanced thrombolysis combining CDT with a sophisticated catheter system that employs high-frequency, low-dose ultrasound. In vitro experiments showed that adding ultrasound to thrombolytic drugs accelerates thrombolysis while Ultrasound exposure alone results in no thrombolysis, however the superiority of ultrasound-enhanced thrombolysis over standard CDT has never been formally assessed in vivo. The hypothesis for this study is that ultrasound-enhanced thrombolysis reaches a higher degree of thrombolysis than standard CDT in patients with symptomatic ilio-femoral DVT.

Conditions

• Venous Thrombosis
• Postthrombotic Syndrome

Interventions

PROCEDURE

CDT+US group

CDT using the EkoSonic Endovascular System with intravascular high-frequency, low-power ultrasound for 15 hours.

PROCEDURE

CDT-US group

CDT using the EkoSonic Endovascular System without intravascular high-frequency, low-power ultrasound for 15 hours.

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern

  lead OTHER

Principal Investigators

• Nils Kucher, MD · Division of Clinical and Interventional Angiology, Swiss Cardiovascular Center, University Hospital and University of Bern

• Torsten Willenberg, MD · Division of Clinical and Interventional Angiology, Swiss Cardiovascular Center, University Hospital and University of Bern

• Iris Baumgartner, MD · Division of Clinical and Interventional Angiology, Swiss Cardiovascular Center, University Hospital and University of Bern

• Rolf P Engelberger, MD · Division of Clinical and Interventional Angiology, Swiss Cardiovascular Center, University Hospital and University of Bern

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-11-30

Primary Completion

2013-11-30

Completion

2014-11-30

Countries

• Switzerland

Study Locations