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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: ACCelerated ThrombolySiS for Post-Thrombotic Syndrome Using EKOS

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

Detailed Summary: 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.
Sponsor: EKOS Corporation

Current Primary Outcome: Change in Villalta Score [ Time Frame: Baseline through 30 days ]

Clinical efficacy will be evaluated using the Villalta score at Baseline compared to 30 days Post-EkoSonic® Study Treatment Procedure.


Original Primary Outcome: Villalta score [ Time Frame: assessed at various intervals during 12 months ]

Villalta is a measure of severity of PTS


Current Secondary Outcome:

Original Secondary Outcome: Quality of Life (QOL) [ Time Frame: various intervals during 12 months ]

QOL will be determined form different surveys


Information By: EKOS Corporation

Dates:
Date Received: June 6, 2014
Date Started: July 10, 2014
Date Completion: December 2017
Last Updated: March 17, 2017
Last Verified: March 2017