NCT02159521

Treatment of Chronic Deep Vein Thrombosis (DVT) and Post-Thrombotic Syndrome (PTS) With the EkoSonic® Endovascular System

ACCElerated ThrombolySiS for Post-Thrombotic Syndrome Using the EKOS System

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy of ultrasound accelerated thrombolysis using the EkoSonic® Endovascular System with standard infusion of thrombolytic drug for post-thrombotic syndrome from chronic venous occlusion.

Detailed description

The study is designed to evaluate the safety and efficacy of ultrasound accelerated thrombolysis using the EkoSonic® Endovascular System with standard infusion of a thrombolytic drug for PTS and chronic DVT. Clinical effectiveness will be evaluated using a standard measure of severity of post-thrombotic syndrome over a year.

Conditions

• Deep Vein Thrombosis
• Post-thrombotic Syndrome

Interventions

Type	Name	Description
DEVICE	EkoSonic® Endovascular System
BIOLOGICAL	Alteplase	Recombinant tissue plasminogen activator

Timeline

• Start date: 2014-07-10
• Primary completion: 2017-11-30
• Completion: 2017-11-30
• First posted: 2014-06-10
• Last updated: 2021-07-19
• Results posted: 2020-02-18

Locations

22 sites across 1 country: United States