Pulmonary EmbolismPhase 3SEATTLE IINCT01513759

Submassive and Massive Pulmonary Embolism Treatment With Ultrasound Accelerated Thrombolysis Therapy

A Phase 3 study testing recombinant tissue plasminogen activator and EKOS EkoSonic Endovascular System in people with Pulmonary Embolism and Acute Pulmonary Embolism, run by Boston Scientific Corporation at 22 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pulmonary Embolism, Acute Pulmonary Embolism, Sub-massive Pulmonary Embolism
What is being tested?: recombinant tissue plasminogen activator and EKOS EkoSonic Endovascular System
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 150 participants
Where: 22 sitesUnited States
Study dates: 7 Jun 2012to 17 Feb 2013
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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 (<=)14 days
Informed consent can be obtained from participant or Legally Authorized Representative (LAR)
Massive PE (syncope, systemic arterial hypotension, cardiogenic shock, or resuscitated cardiac arrest) or
Submassive PE (RV diameter-to-LV diameter greater than or equal to [>=] 0.9 on contrast-enhanced chest CT)

Who cannot join

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 (<) 30 percent (%)
Platelets < 100 thousand/microliter (mcL)
International Normalized Ratio (INR) greater than (>) 3
Activated partial thromboplastin time (aPTT) >50 seconds on no anticoagulants

Show all 18Show fewer

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

Trial locations and contacts

22 sites in 1 country.

City, postcode or hospital

22 sites in 1 country

United States22 sites

Inova Alexandria Hospital
Alexandria, Virginia, 22304
Mt. Carmel East
Columbus, Ohio, 43213
Providence Memorial and Sierra Medical Center
El Paso, Texas, 79902
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Hartford Hospital
Hartford, Connecticut
St. Vincent Hospital
Indianapolis, Indiana
Lakeland Regional Medical Center
Lakeland, Florida, 33805
University of Kentucky, Gill Heart Institute
Lexington, Kentucky, 40536
Medical Center of Central Georgia
Macon, Georgia, 31201
Holmes Regional Medical Center
Melbourne, Florida, 32901
Memorial Medical Center
Modesto, California, 95355
Baptist Health
Montgomery, Alabama, 36116
Overlook Medical Center
Morristown, New Jersey, 07960
East Jefferson General Hospital
New Orleans, Louisiana, 70006
Christiana Hospital
Newark, Delaware, 19718
Florida Hospital
Orlando, Florida, 32803
Orlando Regional Medical Center
Orlando, Florida, 32806
The Miriam Hospital
Providence, Rhode Island, 02906
Prairie Heart Institute
Springfield, Illinois, 62701
Stanford University Medical Center
Stanford, California, 94305
Holy Name Hospital
Teaneck, New Jersey, 07666
Montefiore Medical Center
The Bronx, New York, 10467

Other trials in United States

About this study

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

Conditions: Pulmonary Embolism, Acute Pulmonary Embolism, Sub-massive Pulmonary Embolism, Massive Pulmonary Embolism, Pulmonary Thromboembolism
Being tested: recombinant tissue plasminogen activator, EKOS EkoSonic Endovascular System
Keywords: Fibrinolysis, catheter directed fibrinolysis, ultrasound accelerated fibrinolysis, recombinant t-PA, Activase
Medical subject headings: Pulmonary Embolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

recombinant tissue plasminogen activatorDrug
Also called r-tPA, t-PA, Alteplase
Participants will receive 24 mg of r-tPA delivered via the EkoSonic Endovascular Device.
EKOS EkoSonic Endovascular SystemDevice
Also called EkoSonic Endovascular Device, EkoSonic
24 mg of r-tPA will be delivered through the EkoSonic Endovascular System.

Study groups in NCT01513759
Study group	Role	What they receive
EkoSonic® Endovascular System	Experimental	Participants will receive a total of 24 milligrams (mg) of recombinant t-PA infusion, at an infusion rate of 1 milligrams/hour (mg/hr) per device (2 mg/hour for bilateral PE) delivered through the EkoSonic® Endovascular System. This regimen allows for a recombinant t-PA infusion time of 24 hours for one catheter and 12 hours for two catheters, respectively. Receives: Drug: recombinant tissue plasminogen activator; Device: EKOS EkoSonic Endovascular System

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in the Right Ventricle (RV) Diameter-to-Left Ventricle (LV) Diameter Ratio Within 48 +/- 6 Hours of Initiation of Therapy
Change from baseline in RV diameter/LV diameter ratio was determined by contrast-enhanced chest computed tomography (CT) within 48 +/- 6 hours after initiating ultrasound-accelerated catheter-directed fibrinolysis.
Measured: Baseline, within 48 +/- 6 hours of initiation of therapy
Number of Participants With Major Bleeding
Bleeding adverse events were graded (severe or life-threatening, moderate or mild bleeding) according to the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) classification. The participant incidence of major bleeding events was defined as GUSTO moderate and severe events occurring within 72 hours after starting the ultrasound-accelerated catheter-directed fibrinolysis procedure. Mild: Does not meet criteria for moderate or severe; Moderate: Requires transfusion - No hemodynamic compromise; and Severe: Bleeding causes hemodynamic compromise and required intervention or intracranial hemorrhage. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Measured: From start of study drug infusion up to 72 hours

Secondary outcomes (4)

Change From Baseline in Pulmonary Artery Systolic Pressure at 48 Hours After Start of Therapy
Change in pulmonary artery systolic pressure was assessed by baseline right-heart catheterization compared with right-heart catheterization at the conclusion of ultrasound-accelerated catheter-directed fibrinolysis and estimated by post-procedure transthoracic echocardiography within 48 hours after initiating the procedure.
Measured: Baseline, Hour 48 after initiation of therapy
Percentage of Participants With Symptomatic Recurrent Pulmonary Embolism (PE)
Percentage of participants with symptomatic recurrent PE up to 30 days following the conclusion of the ultrasound-accelerated catheter-directed fibrinolysis procedure, were reported with a Wilson score 95% confidence interval. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Measured: Baseline up to Day 30
Number of Participants Who Died Due to Any Cause
Number of participants who died due to any cause for up to 30 days following the conclusion of the ultrasound-accelerated catheter-directed fibrinolysis procedure, were reported.
Measured: Baseline up to Day 30
Number of Devices That Could Not be Successfully Used for Infusion
Technical complications associated with the use of the EkoSonic device was recorded during catheter placement in the pulmonary artery and during the infusion procedure.
Measured: Baseline up to Day 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Jun 201217 Feb 2013

First posted20 Jan 2012 (estimated)
Study start7 Jun 2012
Primary completion17 Feb 2013
Study completion17 Feb 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01513759
Sponsor's protocol ID: EKOS 09
Acronym: SEATTLE II
Status last verified: Jul 2021
First submitted: 17 Jan 2012
Last updated: 19 Jul 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Sadiq I, Goldhaber SZ, Liu PY, Piazza G; Submassive and Massive Pulmonary Embolism Treatment with Ultrasound AcceleraTed ThromboLysis ThErapy (SEATTLE II) Investigators. Risk factors for major bleeding in the SEATTLE II trial. Vasc Med. 2017 Feb;22(1):44-50. doi: 10.1177/1358863X16676355. Epub 2017 Jan 31.
PubMed 27913777
Piazza G, Hohlfelder B, Jaff MR, Ouriel K, Engelhardt TC, Sterling KM, Jones NJ, Gurley JC, Bhatheja R, Kennedy RJ, Goswami N, Natarajan K, Rundback J, Sadiq IR, Liu SK, Bhalla N, Raja ML, Weinstock BS, Cynamon J, Elmasri FF, Garcia MJ, Kumar M, Ayerdi J, Soukas P, Kuo W, Liu PY, Goldhaber SZ; SEATTLE II Investigators. 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. JACC Cardiovasc Interv. 2015 Aug 24;8(10):1382-1392. doi: 10.1016/j.jcin.2015.04.020.
PubMed 26315743

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System
Pulmonary Embolism
Not yet recruiting
Pilot Study Evaluating Catheter Directed Thrombolysis Device in Acute Intermediate Risk Pulmonary Embolism
Pulmonary Embolism (PE), Pulmonary Embolism With Right Ventricle Enlargement
RecruitingObservational study
Inari VISION Registry
Pulmonary Embolism
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)

All Pulmonary Embolism trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Single-Arm, Multi-Center Trial of EkoSonic® Endovascular System and Activase for Treatment of Acute Pulmonary Embolism (PE)
ClinicalTrials.gov ID: NCT01513759
Acronym / sponsor ID: SEATTLE II / EKOS 09
Conditions: Pulmonary Embolism, Acute Pulmonary Embolism, Sub-massive Pulmonary Embolism, Massive Pulmonary Embolism, Pulmonary Thromboembolism
Keywords: Fibrinolysis, catheter directed fibrinolysis, ultrasound accelerated fibrinolysis, recombinant t-PA, Activase
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: Boston Scientific CorporationIndustry (pharma, biotech, devices)
Collaborators: EKOS Corporation
Study start: 7 Jun 2012 (actual)
Primary completion: 17 Feb 2013 (actual)
Study completion: 17 Feb 2013 (actual)
First posted: 20 Jan 2012 (estimated)
Results: Posted 5 Jul 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
EkoSonic® Endovascular System	Experimental	Drug: recombinant tissue plasminogen activator, Device: EKOS EkoSonic Endovascular SystemParticipants will receive a total of 24 milligrams (mg) of recombinant t-PA infusion, at an infusion rate of 1 milligrams/hour (mg/hr) per device (2 mg/hour for bilateral PE) delivered through the EkoSonic® Endovascular System. This regimen allows for a recombinant t-PA infusion time of 24 hours for one catheter and 12 hours for two catheters, respectively.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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 (<=)14 days
Informed consent can be obtained from participant or Legally Authorized Representative (LAR)
Massive PE (syncope, systemic arterial hypotension, cardiogenic shock, or resuscitated cardiac arrest) or
Submassive PE (RV diameter-to-LV diameter greater than or equal to [>=] 0.9 on contrast-enhanced chest CT)

Key exclusion criteria (18 listed)

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 (<) 30 percent (%)
Platelets < 100 thousand/microliter (mcL)
International Normalized Ratio (INR) greater than (>) 3

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
recombinant tissue plasminogen activatorAlso: r-tPA, t-PA, AlteplaseParticipants will receive 24 mg of r-tPA delivered via the EkoSonic Endovascular Device.	Drug	EkoSonic® Endovascular System
EKOS EkoSonic Endovascular SystemAlso: EkoSonic Endovascular Device, EkoSonic24 mg of r-tPA will be delivered through the EkoSonic Endovascular System.	Device	EkoSonic® Endovascular System

Primary outcome

Change From Baseline in the Right Ventricle (RV) Diameter-to-Left Ventricle (LV) Diameter Ratio Within 48 +/- 6 Hours of Initiation of Therapy
Time frame: Baseline, within 48 +/- 6 hours of initiation of therapy
Change from baseline in RV diameter/LV diameter ratio was determined by contrast-enhanced chest computed tomography (CT) within 48 +/- 6 hours after initiating ultrasound-accelerated catheter-directed fibrinolysis.
Number of Participants With Major Bleeding
Time frame: From start of study drug infusion up to 72 hours
Bleeding adverse events were graded (severe or life-threatening, moderate or mild bleeding) according to the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) classification. The participant incidence of major bleeding events was defined as GUSTO moderate and severe events occurring within 72 hours after starting the ultrasound-accelerated catheter-directed fibrinolysis procedure. Mild: Does not meet criteria for moderate or severe; Moderate: Requires transfusion - No hemodynamic compromise; and Severe: Bleeding causes hemodynamic compromise and required intervention or intracranial hemorrhage. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

4 secondary outcomes

Change From Baseline in Pulmonary Artery Systolic Pressure at 48 Hours After Start of Therapy
Time frame: Baseline, Hour 48 after initiation of therapy
Percentage of Participants With Symptomatic Recurrent Pulmonary Embolism (PE)
Time frame: Baseline up to Day 30
Number of Participants Who Died Due to Any Cause
Time frame: Baseline up to Day 30
Number of Devices That Could Not be Successfully Used for Infusion
Time frame: Baseline up to Day 30

Results and safety

Results posted to the registry on 5 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
EkoSonic® Endovascular System	150	145

Primary outcome: Change From Baseline in the Right Ventricle (RV) Diameter-to-Left Ventricle (LV) Diameter Ratio Within 48 +/- 6 Hours of Initiation of Therapy

Time frame: Baseline, within 48 +/- 6 hours of initiation of therapy. Mean (Standard Deviation). Unit: ratio

Measure	EkoSonic® Endovascular System n = 150
Baseline	1.55 (0.39)
Change within 48 +/- 6 hours	-0.42 (0.36)

Population analysed: Efficacy analysis set included all participants who started the ultrasound accelerated thrombolysis therapy. Here, 'Overall number of participants analyzed' signifies participants with available data at both baseline and post-baseline. 'Number analyzed' signifies participants with available data at specified timepoint.

Primary outcome: Number of Participants With Major Bleeding

Time frame: From start of study drug infusion up to 72 hours. Count of participants. Unit: Participants

Measure	EkoSonic® Endovascular System n = 150
Value	14

Population analysed: Safety analysis set included all participants who started the EkoSonic device placement procedure.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to Day 30. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
EkoSonic® Endovascular System	28 of 150 (18.7%)	59 of 150 (39.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27913777Sadiq I, Goldhaber SZ, Liu PY, Piazza G; Submassive and Massive Pulmonary Embolism Treatment with Ultrasound AcceleraTed ThromboLysis ThErapy (SEATTLE II) Investigators. Risk factors for major bleeding in the SEATTLE II trial. Vasc Med. 2017 Feb;22(1):44-50. doi: 10.1177/1358863X16676355. Epub 2017 Jan 31.
Derived from this study: PubMed 26315743Piazza G, Hohlfelder B, Jaff MR, Ouriel K, Engelhardt TC, Sterling KM, Jones NJ, Gurley JC, Bhatheja R, Kennedy RJ, Goswami N, Natarajan K, Rundback J, Sadiq IR, Liu SK, Bhalla N, Raja ML, Weinstock BS, Cynamon J, Elmasri FF, Garcia MJ, Kumar M, Ayerdi J, Soukas P, Kuo W, Liu PY, Goldhaber SZ; SEATTLE II Investigators. 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. JACC Cardiovasc Interv. 2015 Aug 24;8(10):1382-1392. doi: 10.1016/j.jcin.2015.04.020.

Related trials for Pulmonary Embolism

RecruitingObservational study
Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System
Pulmonary Embolism
Not yet recruiting
Pilot Study Evaluating Catheter Directed Thrombolysis Device in Acute Intermediate Risk Pulmonary Embolism
Pulmonary Embolism (PE), Pulmonary Embolism With Right Ventricle Enlargement
RecruitingObservational study
Inari VISION Registry
Pulmonary Embolism
RecruitingPhase 3
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RecruitingPhase 3
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Cancer-Associated Thrombosis (CAT)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Narinder Bhalla, MD principal investigator

Baptist Health

William Kuo, MD principal investigator

Stanford Hospital and Clinics

Stephen K Liu, MD principal investigator

Memorial Medical Center - Modesto

22 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in the Right Ventricle (RV) Diameter-to-Left Ventricle (LV) Diameter Ratio Within 48 +/- 6 Hours of Initiation of Therapy (time frame: Baseline, within 48 +/- 6 hours of initiation of therapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01513759, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2021.