NCT02396758

Optimum Duration of Acoustic Pulse Thrombolysis Procedure in Acute Pulmonary Embolism

Study of the OPTtimum Duration of Acoustic Pulse ThromboLYSis ProcEdure in the Treatment of Acute Submassive Pulmonary Embolism

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 131 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The objective is to determine the optimum dose of thrombolytic and duration of the ultrasound procedure (together defined as the APT Procedure) as a treatment for acute submassive pulmonary embolism (PE). Symptomatic submassive PE are participants with acute (less than or equal to \[≤\]14 days) PE with normal systemic arterial blood pressure (greater than \[\>\] 90 mmHg) and evidence of RV dysfunction (right ventricular to left ventricular diameter ratio, that is; RV/LV ratio greater than or equal to \[≥\] 0.9). Participants with submassive PE will be randomized to one of four APT treatment groups: ultrasound of 2 and 6 hours (hrs) with r-tPA 2 milligrams (mg)/hr/catheter and ultrasound 4 and 6 hours with r-tPA, 1 mg/hr/catheter. On 08 June 2016, randomization into treatment group 4 (APT/6 hours-r-tPA/2 mg/hr/catheter) was closed following a reported intracranial hemorrhage (ICH) and death in a study participant in this arm.

Detailed description

This study is designed to investigate the lowest recombinant tissue plasminogen activator (r-tPA) dose-ultrasound treatment time required to achieve the same reductions in thrombus burden and associated improvement in physiologic parameters demonstrated in ULTIMA (EKOS 08 \[NCT01166997\]) and SEATTLE II (EKOS 09 \[NCT01513759\]). Results of this study are intended to inform the study design for further studies of the Acoustic Pulse Thrombolysis (APT) Procedure. Analysis of the first 100 evaluable participants in the United States study suggested a degree of equipoise between treatment groups 1, 2 and 3 of the protocol and therefore the sample size has been extended and additional sites in the United Kingdom (UK) National Health Service included, with a view to adding to the findings of the OPTALYSE study from sites in the UK and increasing the number of participants treated by treatment protocol.

Conditions

• Pulmonary Embolism and Thrombosis

Interventions

Type	Name	Description
DEVICE	Ekosonic® Endovascular Device ultrasonic infusion catheter	r-tPA will be administered via EKOS.
BIOLOGICAL	Recombinant tissue plasminogen activator	Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm.

Timeline

• Start date: 2015-06-12
• Primary completion: 2019-04-30
• Completion: 2020-01-30
• First posted: 2015-03-24
• Last updated: 2021-07-19
• Results posted: 2021-03-02

Locations

21 sites across 2 countries: United States, United Kingdom