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NCT02396758 · ClinicalTrials.gov registry record · Phase 4
Optimum Duration of Acoustic Pulse Thrombolysis Procedure in Acute Pulmonary Embolism
A Phase 4 study, sponsored by Boston Scientific Corporation.
- Completed
- Registry status
- Phase 4
- Development phase
- 131
- Enrollment target
NCT02396758 is a Phase 4 study that has completed, run by Boston Scientific Corporation. The registered enrollment target is 131 participants.
The verdict
NCT02396758, a Phase 4 study, has completed, sponsored by Boston Scientific Corporation.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 131 participants
- Enrollment target
Study 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.
Interventions
- DEVICE Ekosonic® Endovascular Device ultrasonic infusion catheter
- BIOLOGICAL Recombinant tissue plasminogen activator
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 131 participants |
| Start Date | 2015-06-12 |
| Est. Completion | 2020-01-30 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02396758
The ClinicalTrials.gov registry entry for NCT02396758 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 131 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Scientific Corporation, which has 280 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Ekosonic® Endovascular Device ultrasonic infusion catheter is the first listed.
NCT02396758 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02396758 about?
NCT02396758 is a clinical study titled "Optimum Duration of Acoustic Pulse Thrombolysis Procedure in Acute Pulmonary Embolism". 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 w...
What is the current status of trial NCT02396758?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 131 participants. The study started on 2015-06-12. Estimated completion is 2020-01-30.
What interventions are being tested in trial NCT02396758?
The interventions under investigation include: Ekosonic® Endovascular Device ultrasonic infusion catheter (DEVICE), Recombinant tissue plasminogen activator (BIOLOGICAL).
Who is sponsoring clinical trial NCT02396758?
This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.
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