Phase 3
Completed N=150
Submassive and Massive Pulmonary Embolism Treatment With Ultrasound Accelerated Thrombolysis Therapy
Chronic Obstructive Pulmonary Disease · Sub-massive Pulmonary Embolism · Massive Pulmonary Embolism
Source: ClinicalTrials.gov NCT01513759 ↗
Enrolled (actual)
150
Serious AEs
18.7%
Results posted
Jul 2019
Primary outcomePrimary: Change From Baseline in the Right Ventricle (RV) Diameter-to-Left Ventricle (LV) Diameter Ratio Within 48 +/- 6 Hours of Initiation of Therapy — 1.55; -0.42 ratio
◆ Published Evidence
Highly cited
922citations · ~84 / year
A Prospective, Single-Arm, Multicenter Trial of Ultrasound-Facilitated, Catheter-Directed, Low-Dose Fibrinolysis for Acute Massive and Submassive Pulmonary Embolism: The SEATTLE II Study.
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.
Linked Publications (2)
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A Prospective, Single-Arm, Multicenter Trial of Ultrasound-Facilitated, Catheter-Directed, Low-Dose Fibrinolysis for Acute Massive and Submassive Pulmonary Embolism: The SEATTLE II Study.
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Risk factors for major bleeding in the SEATTLE II trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Right Ventricle (RV) Diameter-to-Left Ventricle (LV) Diameter Ratio Within 48 +/- 6 Hours of Initiation of Therapy |
1.55; -0.42 | — |
| PRIMARY Number of Participants With Major Bleeding |
14 | — |
| SECONDARY Change From Baseline in Pulmonary Artery Systolic Pressure at 48 Hours After Start of Therapy |
51.4; -14.4 | — |
| SECONDARY Percentage of Participants With Symptomatic Recurrent Pulmonary Embolism (PE) |
— | — |
| SECONDARY Number of Participants Who Died Due to Any Cause |
4 | — |
| SECONDARY Number of Devices That Could Not be Successfully Used for Infusion |
7 | — |
Eligibility Criteria
Inclusion Criteria
- Computed tomography (CT) evidence of proximal PE (filling defect in at least one main or segmental pulmonary artery)
- PE symptom duration less than or equal to ( =] 0.9 on contrast-enhanced chest CT)
Exclusion Criteria
- Stroke or transient ischemic attack (TIA), head trauma, or other active intracranial or intraspinal disease within one year
- Recent (within one month) or active bleeding from a major organ
- Hematocrit less than ( ) 3
- Activated partial thromboplastin time (aPTT) >50 seconds on no anticoagulants
- Major surgery within seven days of screening for study enrollment
- Serum creatinine >2 milligrams/deciliter (mg/dL)
- Clinician deems high-risk for catastrophic bleeding
- History of heparin-induced thrombocytopenia (HIT)
- Pregnancy
- Catheter-based pharmacomechanical treatment for pulmonary embolism within 3 days of study enrollment
- Systolic blood pressure less than 80 mm Hg despite vasopressor or inotropic support
- Cardiac arrest (including pulseless electrical activity and asystole) requiring active cardiopulmonary resuscitation (CPR)
- Evidence of irreversible neurological compromise
- Life expectancy <30 days
- Use of thrombolytics or glycoprotein IIb/IIIa antagonists within 3 days prior to inclusion in the study
- Previous enrollment in the SEATTLE study
Data sourced from ClinicalTrials.gov (NCT01513759) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.