CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 150 enrolled
Drug / intervention
recombinant tissue plasminogen activator +1 moredrug
Likely dose
recombinant tissue plasminogen activator 24 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01513759
NCT01513759Phase 3Completed
CompareCT.gov

A Prospective, Single-Arm, Multi-Center Trial of EkoSonic® Endovascular System and Activase for Treatment of Acute Pulmonary Embolism (PE)

Boston Scientific Corporation·interventional·Posted Jan 20, 2012·Updated Jul 19, 2021

In Brief

A Phase 3 clinical trial evaluating recombinant tissue plasminogen activator and EKOS EkoSonic Endovascular System for Pulmonary Embolism and 4 related conditions. Completed, enrolled 150 participants across 22 sites.

Detailed Summary

The purpose of this study is to determine if the EKOS EkoSonic® Endovascular Device when used in conjunction with recombinant tissue plasminogen activator (t-PA) as a treatment for acute PE will decrease the ratio of right ventricle (RV) to left ventricle (LV) diameter within 48 =/- 6 hours in participants with massive or submassive PE.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Embolism, Acute Pulmonary Embolism, Sub-massive Pulmonary Embolism, Massive Pulmonary Embolism, Pulmonary Thromboembolism
CountriesUnited States
CollaboratorsEKOS Corporation

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 20, 2012
Enrollment StartJun 7, 2012
Primary CompletionFeb 17, 2013
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 14.5 years ago

Interventions

recombinant tissue plasminogen activatordrug

Participants will receive 24 mg of r-tPA delivered via the EkoSonic Endovascular Device.

EKOS EkoSonic Endovascular Systemdevice

24 mg of r-tPA will be delivered through the EkoSonic Endovascular System.