Clinical trial NCT01513759: Submassive and Massive Pulmonary Embolism Treatment With Ultrasound Accelerated Thrombolysis Therapy
Official title: A Prospective, Single-Arm, Multi-Center Trial of EkoSonic® Endovascular System and Activase for Treatment of Acute Pulmonary Embolism (PE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
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
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
Collaborators: name: EKOS Corporation
First posted: 2012-01-20
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


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 (\<=)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)

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 (\<) 30 percent (%)
* Platelets \< 100 thousand/microliter (mcL)
* International Normalized Ratio (INR) greater 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

Primary outcomes:
measure: Change From Baseline in the Right Ventricle (RV) Diameter-to-Left Ventricle (LV) Diameter Ratio Within 48 +/- 6 Hours of Initiation of Therapy
timeFrame: Baseline, within 48 +/- 6 hours of initiation of therapy
measure: Number of Participants With Major Bleeding
timeFrame: From start of study drug infusion up to 72 hours
Secondary outcomes:
measure: Change From Baseline in Pulmonary Artery Systolic Pressure at 48 Hours After Start of Therapy
timeFrame: Baseline, Hour 48 after initiation of therapy
measure: Percentage of Participants With Symptomatic Recurrent Pulmonary Embolism (PE)
timeFrame: Baseline up to Day 30
measure: Number of Participants Who Died Due to Any Cause
timeFrame: Baseline up to Day 30
measure: Number of Devices That Could Not be Successfully Used for Infusion
timeFrame: Baseline up to Day 30
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Baptist Health
state: Alabama
city: Modesto
country: United States
facility: Memorial Medical Center
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Newark
country: United States
facility: Christiana Hospital
state: Delaware
city: Lakeland
country: United States
facility: Lakeland Regional Medical Center
state: Florida
city: Melbourne
country: United States
facility: Holmes Regional Medical Center
state: Florida
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Orlando
country: United States
facility: Orlando Regional Medical Center
state: Florida
city: Macon
country: United States
facility: Medical Center of Central Georgia
state: Georgia
city: Springfield
country: United States
facility: Prairie Heart Institute
state: Illinois
city: Indianapolis
country: United States
facility: St. Vincent Hospital
state: Indiana
city: Lexington
country: United States
facility: University of Kentucky, Gill Heart Institute
state: Kentucky
city: New Orleans
country: United States
facility: East Jefferson General Hospital
state: Louisiana
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Morristown
country: United States
facility: Overlook Medical Center
state: New Jersey
city: Teaneck
country: United States
facility: Holy Name Hospital
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Columbus
country: United States
facility: Mt. Carmel East
state: Ohio
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
city: El Paso
country: United States
facility: Providence Memorial and Sierra Medical Center
state: Texas
city: Alexandria
country: United States
facility: Inova Alexandria Hospital
state: Virginia
Study officials:
affiliation: Baptist Health
name: Narinder Bhalla, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford Hospital and Clinics
name: William Kuo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Memorial Medical Center - Modesto
name: Stephen K Liu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hartford Hospital
name: Immad Sidiq, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brigham and Women's
name: Samuel Z Goldhaber, MD
role: STUDY_CHAIR
affiliation: Christiana Hospital
name: Mark J Garcia, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AdventHealth
name: Rohit Bhatheja, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Holmes Regional Medical Center
name: Robert Kennedy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lakeland Regional Medical Center
name: Fakhir Elmasri, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Orlando Regional Medical Center
name: Barry S Weinstock, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical Center of Central Georgia
name: Juan Ayerdi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Prairie Heart Institute - St.John's Hospital
name: Nilesh Goswami, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St Vincent's Hospital
name: Kannan Natarajan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: East Jefferson General Hospital
name: Tod C Engelhardt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Overlook Medical Center
name: Mark Kumar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Holy Name Hospital
name: John Rundback, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Montefiore Medical Center
name: Jacob Cynamon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Miriam Hospital
name: Peter Soukas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Providence Memorial Hospital - Sierra Vista Hospital
name: Mohammad L Raja, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Inova Alexandria
name: Keith M Sterling, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Kentucky
name: John Gurley, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mt. Carmel East
name: Noah Jones, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.