Optimum Duration of Acoustic Pulse Thrombolysis Procedure in Acute Pulmonary Embolism
Public ClinicalTrials.gov record NCT02396758. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Study of the OPTtimum Duration of Acoustic Pulse ThromboLYSis ProcEdure in the Treatment of Acute Submassive Pulmonary Embolism
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02396758
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 131 participants
Conditions and interventions
Conditions
Interventions
- Ekosonic® Endovascular Device ultrasonic infusion catheter Device
- Recombinant tissue plasminogen activator Biological
Device · Biological
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 12, 2015 (Actual)
- Primary completion
- Apr 30, 2019 (Actual)
- Completion
- Jan 30, 2020 (Actual)
- Last update posted
- Jul 19, 2021
2015 – 2020
United States locations
- U.S. sites
- 16
- U.S. states
- 13
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cedars Sinai | Beverly Hills | California | 90211 | — |
| Tallahassee Memorial Hospital | Tallahassee | Florida | 32308 | — |
| Florida Hospital Tampa | Tampa | Florida | 33613 | — |
| Piedmont Hospital | Atlanta | Georgia | 30309 | — |
| University Hospital | Augusta | Georgia | 30901 | — |
| St. Vincent Medical Group | Indianapolis | Indiana | 46260 | — |
| Jewish Hospital | Louisville | Kentucky | 40202 | — |
| East Jefferson General Hospital | Metairie | Louisiana | 70006 | — |
| Detroit Medical Center | Detroit | Michigan | 48201 | — |
| Mount Carmel Health System | Columbus | Ohio | 43213 | — |
| UPMC Hamot | Erie | Pennsylvania | 16507 | — |
| Lankenau Medical Center | Wynnewood | Pennsylvania | 19096 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Houston Methodist Sugarland Hospital | Richmond | Texas | 77469 | — |
| Inova Alexandria Hospital | Alexandria | Virginia | — | — |
| Providence Sacred Heart Medical Center | Spokane | Washington | 99204 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02396758, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 19, 2021 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02396758 live on ClinicalTrials.gov.