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

Phase 4 Completed 81 enrolled Boston Scientific Corporation EKOS Corporation · collab

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2014-07-10
Primary completion: 2017-11-30
Completion: 2017-11-30

Outcome

Met primary endpoint

paper The primary end point was met in 64.6% (51/79). PMID 31983322 ↗

Publications

Garcia MJ, Sterling KM, Kahn SR, Comerota AJ, Jaff MR, Ouriel K, Weinberg I; ACCESS PTS Investigators. Ultrasound-Accelerated Thrombolysis and Venoplasty for the Treatment of the Postthrombotic Syndrome: Results of the ACCESS PTS Study. J Am Heart Assoc. 2020 Feb 4;9(3):e013398. doi: 10.1161/JAHA.119.013398. Epub 2020 Jan 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Alteplase	Protein / enzyme biologic	0.5 mg	—
Subject	Alteplase	Protein / enzyme biologic	1 mg	—