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Optimum Duration of Acoustic Pulse Thrombolysis Procedure in Acute Pulmonary Embolism (OPTALYSE PE)

Primary Purpose

Pulmonary Embolism and Thrombosis

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Ekosonic® Endovascular Device ultrasonic infusion catheter

Recombinant tissue plasminogen activator

About this trial

This is an interventional treatment trial for Pulmonary Embolism and Thrombosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female greater than or equal to (≥) 18 years of age and less than or equal to (≤) 75 years of age.
CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery).
PE symptom duration ≤14 days.
Submassive PE: RV/LV diameter ≥ 0.9 from CTA and hemodynamically stable. For Participants in UK Sites: Submassive PE: RV/LV diameter ≥ 0.9 from CTA, hemodynamically stable and an elevated biomarker.
Must be treated within 48 hours of diagnosis of PE by CTA.
Signed Informed consent obtained from subject or Legally Authorized Representative.

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.
Major surgery within seven days of screening for study enrollment.
Clinician deems the subject high-risk for catastrophic bleeding.
History of heparin-induced thrombocytopenia (HIT).
Catheter-based pharmacomechanical treatment for PE within 3 days of study enrollment.
Systolic blood pressure (SBP) less than 90 mm Hg and/or use of vasopressors.
Cardiac arrest (including pulseless electrical activity and asystole) requiring active cardiopulmonary resuscitation (CPR).
Evidence of irreversible neurological compromise.
Life expectancy < one year. For Participants in UK Sites: Life expectancy < one year or enrollment in hospice care.
Use of thrombolytics or glycoprotein IIb/IIIa antagonists within 3 days prior to inclusion in the study.
Out-of-Range Laboratory Values: Hematocrit < 30%, Platelets < 100 thousand/microliter (μL), International normalized ratio (INR) > 3.
Creatinine outside the normal range for the treating institution.
Participant is pregnant (positive pregnancy test; women of childbearing capacity must be tested) or breast feeding.
Active cancer (metastatic, progressive, or treated within the last 6 months). Exception: participants with non-melanoma primary skin cancers are eligible to participate in the study.
Known allergy, hypersensitivity, or thrombocytopenia from heparin, r-tPA, or iodinated contrast except for mild-moderate contrast allergies for which steroid pre-medication can be used.
History of any hematologic disease potentially involving abnormal platelet number or function.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

APT/2 Hours-r-tPA/2 mg/hr/Catheter

APT/4 Hours-r-tPA/1 mg/hr/Catheter

APT/6 Hours-r-tPA/1 mg/hr/Catheter

APT/6 Hours-r-tPA/2 mg/hr/Catheter

Arm Description

A total of 4 or 8 mg r-tPA (as 2 mg/hour [hr]/catheter) will be delivered through Ekosonic® Endovascular Device (EKOS) ultrasonic infusion catheter for 2 hrs.

A total of 4 or 8 mg r-tPA (as 1 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 4 hrs.

A total of 6 or 12 mg r-tPA (as 1 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs.

A total of 12 or 24 mg r-tPA (as 2 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs.

Outcomes

Primary Outcome Measures

Change From Baseline in the Right Ventricle (RV) Diameter-to-Left Ventricle (LV) Diameter Ratio to 48 ± 6 Hours After the Start of the APT Procedure

Change from baseline in RV/LV will be determined by computed tomographic angiography (CTA).

Number of Participants With Major Bleeding Within 72 Hours After Initiating the APT Procedure

Criteria for major bleeding events, as defined by the International Society on Thrombosis and Haemostasis (ISTH): 1. Fatal bleeding and/or; 2. Symptomatic bleeding in a critical area or organ (intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome) and/or; 3. Bleeding causing a fall in hemoglobin level of 20 grams/liter (g/L) or more, or leading to transfusion of two or more units of whole blood or red blood cells.

Secondary Outcome Measures

Percentage of Participants With Treatment Success of an APT Procedure

Treatment success of an APT procedure will be assessed by an Adjudication Committee that is blinded to the participant's treatment. The criteria for treatment success are defined as follows: A decrease in RV/LV from baseline to 48 hours after the start of the procedure of at least 0.2; and no life-threatening adverse events related to PE or its treatment through 30 days after the start of the APT procedure.

Change From Baseline in RV/LV at Days 0, 2, 30, 90, and 365, as Assessed by Echocardiograph.

An echocardiogram was obtained at specified timepoints to evaluate RV/LV.

Change From Baseline in Tricuspid Annular Plane Systolic Excursion (TAPSE) at Days 0, 2, 30, 90, and 365, as Assessed by Echocardiograph

The extent of displacement of the tricuspid valves, termed as TAPSE was measured at specified timepoints using echocardiogram.

Change From Baseline in Estimated Right Ventricular Systolic Pressure (RVSP) at Days 0, 2, 30, 90, and 365, as Assessed by Echocardiograph

RVSP was measured at specified timepoints using echocardiogram.

Percentage of Participants With Collapse of the Inferior Vena Cava (IVC) With Respiration at Days 0, 2, 30, 90, and 365, as Assessed by Echocardiograph

The collapse of IVC was measured at specified timepoints using echocardiogram.

Change From Baseline in Thrombus Burden by Miller Score as Assessed by Pulmonary Arteriogram (PAgram) at Day 0

Miller score is composed of a score for arterial obstruction (objective score) and a score for reduction of peripheral perfusion of lungs (subjective evaluation). Right pulmonary artery (PA) is assigned 9 segmental arteries (3 to the upper, 2 to the middle, and 4 to the lower lobe), and left PA is assigned only 7 segmental arteries (2 to the upper, 2 to the lingula, and 3 to the lower lobe). Presence of segmental emboli, regardless of the degree of obstruction, is scored 1 point. Proximal emboli to the segmental level are scored a value equal to the number of segmental arteries arising distally. Maximal score of obstruction=16. Reduction of peripheral perfusion is scored by dividing each lung into upper, middle, and lower zones and by using a 4-point scale: 0=normal perfusion; 1=moderately reduced perfusion; 2=severely reduced perfusion; 3=no perfusion. Maximal score of reduced perfusion=18. Thus, the maximal Miller score =34. Higher Miller score=more thrombus burden.

Change From Baseline in Thrombus Burden by Modified Miller Score as Assessed by CTA Scan at 48 ± 6 Hours After the Start of the APT Procedure

Modified miller score quantifies thrombus burden on CTA scans. Each segmental pulmonary artery (9 on the right, 7 on the left) that is fully or partly occluded by thrombus is given a score of 1. Any further proximal involves vessels score the number of segmental branches distal to that vessel, thereby giving a modified miller score of 0 (no thrombus) to 16 (thrombus in all segmental arteries or saddle embolism).

Change in 6 Minute Walk (6MW) Distance From Day 30 to Day 90 and 365

The 6 minute Walk Test is a measure of functional exercise capacity. Participants will be asked to walk as far as possible within a 6-minute period, and the distance covered at the end will be noted and recorded.

Change in Borg Scale Score Before and After 6MW Distance Test at Days 30, 90, and 365

Borg is a 10-point scale rating the maximum level of dyspnea (difficulty in breathing) and fatigue experienced before and after the 6MW distance test. Scores ranges from 0 (for no shortness of breath, or no fatigue) to 10 (for the greatest shortness of breath ever experienced, or maximum amount of fatigue felt). Higher scores indicates worse outcome.

Number of Participants Who Received Oxygen Therapy

Oxygen source is categorized as room air, nasal prongs, mask, and intubated.

Change in Participant Reported Outcomes Measurement Information System Physical Function (PROMIS-PF) 6b Score From Day 30 to Day 365

PROMIS-PF 6b questionnaire is developed by including 2-items from item-improved Health Assessment Questionnaire (HAQ) and 4-items from item-improved Physical Function-10 (PF-10) instruments. Both of these instruments assess participant's present abilities. Both "Item-Improved instruments" have 5-response options: HAQ - 1="without any difficulty," 2="with a little difficulty," 3="with some difficulty," 4="with much difficulty," 5="unable to do"; PF-10 - 1="not at all," 2="very little," 3="somewhat," 4="quite a lot," 5="cannot do." Total score is the average of all scores of component items, which ranges from 0 (no disability) to 100 (worst disability).

Change in Pulmonary Embolism Quality of Life (PEmb-QOL) Score From Day 30 to Day 365

The PEmb-QoL questionnaire contains 6 dimensions that has been created based on the contents of the items, frequency of complaints (Question [Q]1; score range: 1 [every day] to 5 [never]), activities of daily living (ADL) limitations (Q4; score range: 1 [limited a lot] to 3 [not at all]), work-related problems (Q5; response: yes/no), social limitations (Q6; score range: 1 [not at all] to 5 [extremely]), intensity of complaints (Q7 [pain in chest/shoulders]/8 [breathlessness]; score range: 1 [none] to 6 [very serious]) and emotional complaints (Q9; score range: 1 [at all times] to 6 [none of the times]). Total Score for all dimensions are calculated by the sum of the scores for each item of the dimension divided by the number of items. Total score ranges from 1 (better quality of life) to 100 (worst quality of life). Higher scores indicate poorer outcome (decreased quality of life). Questions 1, 4, 5, and 9 are reverse scored. Questions 2 and 3 provide descriptive information.

Number of Participants Who Encountered Technical Procedural Complications

Technical complications associated with the use of the EKOS device will be recorded during catheter placement in the pulmonary artery and during the infusion procedure.

Number of Participants With Symptomatic Recurrent Pulmonary Embolism (Per Adjudication)

Number of participants with symptomatic recurrent pulmonary embolism up to 365 days following the APT procedure, were reported. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

Number of Participants Who Die Due to Any Cause

Number of participants who died due to any cause for up to 365 days following the APT procedure, were reported.

For Participants of UK Sites: Freedom From Major Harm Occurring Between Enrolment and 30 Days

Number of UK participants with freedom from major harms assessed by Safety Monitor using the following criteria: 1) Mortality - all cause and PE related; 2) Cardiovascular (CV) collapse defined as one or more of the following: a) Greater than (>) 40 millimeters of mercury (mmHg) drop in systolic blood pressure (SBP) (for >15 minutes from documented blood pressure as an in-patient) despite intravenous (IV) fluid challenge and absence of new atrial arrhythmia; b) Requirement for emergency systemic thrombolysis; c) Requirement for emergency surgical embolectomy ; d) Requirement for vasopressors; e)and/or Intubation/Ventilation; 3) Major bleeding per ISTH; 4) Recurrent PE (confirmed by imaging); and/or 5) Surgical correction of device related complication. Due to changes in the protocol, there were no subjects enrolled in the UK in Treatment Arm 4.

For Participants of UK Sites:Change in EuroQual - 5 Dimensions - 5 Levels (EQ-5D-5L) Score From Day 30 to Day 365

The EQ-5D-5L consists of 2 parts - the descriptive system (Index Score) and the EQ Visual Analogue scale (VAS Score). The EQ-5D-5L descriptive system comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression) and each dimension has 5 levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4), and extreme problems (5). Each one digit number expressing the level selected for each dimension is combined into a 5-digit number describing the respondent's heath state. These 5-digit numbers are converted into an index value, where 1 represents full health and 0 is equivalent to death. The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale with 100 being the best health imaginable and 0 being the worst health imaginable. Due to changes in the protocol, there were no subjects enrolled in the UK in Treatment Arm 4.

For Participants of UK Sites: Time From Hospital Admission to Diagnosis of PE

Duration of time between hospital admission and the diagnosis of pulmonary embolism (PE) measured in hours for UK participants.Due to changes in the protocol, there were no subjects enrolled in the UK in Treatment Arm 4.

For Participants of UK Sites: Time From Diagnostic Computed Tomography (CT) Scan to Initiation of Treatment for PE

Duration of time between Diagnostic Computed Tomography (CT) Scan to Initiation of Treatment for pulmonary embolism (PE) measured in hours for UK Participants. Due to changes in the protocol, there were no subjects enrolled in the UK in Treatment Arm 4.

For Participants of UK Sites: Time in Each Level of Care (Level 0 and 1; Level 2; and/or Level 3) Through Discharge

Levels are defined according to National Framework Document: Level 0 - normal acute ward care (patients whose needs can be met through normal ward care in an acute hospital), Level 1 - acute ward care, with additional advice and support from the critical care team (Patients at risk of their condition deteriorating, or those recently relocated from higher levels of care, whose needs can be met on an acute ward with additional advice from a critical care team), Level 2 - more detailed observation or intervention (requiring more detailed observation or intervention including support for a single failing organ system or post-operative care and those 'stepping down' from higher levels of care) and Level 3 - advanced respiratory support alone, or basic respiratory support together with support of at least two organ systems (includes all complex patients requiring support for multi-organ failure). Due to changes in the protocol, there were no subjects enrolled in the UK in Treatment Arm 4.

Healthcare Resource Utilization: Team Managing the Participant During Hospitalization - Number of Healthcare Professional (HCP) Specialties Involved. (UK Participants Only)

Number of Healthcare Professional (HCP) Specialists involved with care of participant during hospitalization of UK participants.Due to changes in the protocol, there were no subjects enrolled in the UK in Treatment Arm 4.

Healthcare Resource Utilization: Number of Healthcare Professionals (HCP) Visits for Venous Thromboembolism (VTE) After Hospitalization and During 12month Follow-up. (UK Participants Only)

Number of Healthcare Professional (HCP) Specialists involved with care of participant for Venous Thromboembolism (VTE) after hospitalization through 365 days for UK participants. Due to changes in the protocol, there were no subjects enrolled in the UK in Treatment Arm 4.

Healthcare Resource Utilization: Number of Healthcare Professionals (HCP) Visits for Venous Thromboembolism (VTE) After Hospitalization and During 12 Month Follow-up. (UK Participants Only)

Healthcare Resource Utilization: Number of Hospital Re-Admissions After Hospitalization and During 12 Month Follow-up. (UK Participants Only)

Number of Hospital Re-Admissions after hospitalization and during 12 month follow-up for UK Participants. Due to changes in the protocol, there were no subjects enrolled in the UK in Treatment Arm 4.

Healthcare Resource Utilization: Duration of Hospital Re-Admissions After Hospitalization and During 12 Month Follow-up. (UK Participants Only)

Duration of Hospital Re-Admissions after hospitalization and during 12 month follow-up for UK Participants. Due to changes in the protocol, there were no subjects enrolled in the UK in Treatment Arm 4.

Full Information

NCT ID

NCT02396758

First Posted

March 10, 2015

Last Updated

July 15, 2021

Sponsor

Boston Scientific Corporation

Collaborators

EKOS Corporation

1. Study Identification

Unique Protocol Identification Number

NCT02396758

Brief Title

Optimum Duration of Acoustic Pulse Thrombolysis Procedure in Acute Pulmonary Embolism

Acronym

OPTALYSE PE

Official Title

Study of the OPTtimum Duration of Acoustic Pulse ThromboLYSis ProcEdure in the Treatment of Acute Submassive Pulmonary Embolism

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

June 12, 2015 (Actual)

Primary Completion Date

April 30, 2019 (Actual)

Study Completion Date

January 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boston Scientific Corporation

Collaborators

EKOS Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed Description

This study is designed to investigate the lowest recombinant tissue plasminogen activator (r-tPA) dose-ultrasound treatment time required to achieve the same reductions in thrombus burden and associated improvement in physiologic parameters demonstrated in ULTIMA (EKOS 08 [NCT01166997]) and SEATTLE II (EKOS 09 [NCT01513759]). Results of this study are intended to inform the study design for further studies of the Acoustic Pulse Thrombolysis (APT) Procedure. Analysis of the first 100 evaluable participants in the United States study suggested a degree of equipoise between treatment groups 1, 2 and 3 of the protocol and therefore the sample size has been extended and additional sites in the United Kingdom (UK) National Health Service included, with a view to adding to the findings of the OPTALYSE study from sites in the UK and increasing the number of participants treated by treatment protocol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Embolism and Thrombosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

131 (Actual)

8. Arms, Groups, and Interventions

Arm Title

APT/2 Hours-r-tPA/2 mg/hr/Catheter

Arm Type

Experimental

Arm Description

A total of 4 or 8 mg r-tPA (as 2 mg/hour [hr]/catheter) will be delivered through Ekosonic® Endovascular Device (EKOS) ultrasonic infusion catheter for 2 hrs.

Arm Title

APT/4 Hours-r-tPA/1 mg/hr/Catheter

Arm Type

Experimental

Arm Description

A total of 4 or 8 mg r-tPA (as 1 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 4 hrs.

Arm Title

APT/6 Hours-r-tPA/1 mg/hr/Catheter

Arm Type

Experimental

Arm Description

A total of 6 or 12 mg r-tPA (as 1 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs.

Arm Title

APT/6 Hours-r-tPA/2 mg/hr/Catheter

Arm Type

Experimental

Arm Description

A total of 12 or 24 mg r-tPA (as 2 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs.

Intervention Type

Device

Intervention Name(s)

Ekosonic® Endovascular Device ultrasonic infusion catheter

Other Intervention Name(s)

Acoustic Pulse Thrombolysis Procedure (APT Procedure), EKOS

Intervention Description

r-tPA will be administered via EKOS.

Intervention Type

Biological

Intervention Name(s)

Recombinant tissue plasminogen activator

Other Intervention Name(s)

r-tPA

Intervention Description

Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm.

Primary Outcome Measure Information:

Title

Change From Baseline in the Right Ventricle (RV) Diameter-to-Left Ventricle (LV) Diameter Ratio to 48 ± 6 Hours After the Start of the APT Procedure

Description

Change from baseline in RV/LV will be determined by computed tomographic angiography (CTA).

Time Frame

Change from Baseline to 48 hrs ± 6 hours

Title

Number of Participants With Major Bleeding Within 72 Hours After Initiating the APT Procedure

Description

Time Frame

Day 3 (within 72 hours after initiating the APT procedure)

Secondary Outcome Measure Information:

Title

Percentage of Participants With Treatment Success of an APT Procedure

Description

Time Frame

From Baseline up to Day 30

Title

Change From Baseline in RV/LV at Days 0, 2, 30, 90, and 365, as Assessed by Echocardiograph.

Description

An echocardiogram was obtained at specified timepoints to evaluate RV/LV.

Time Frame

Baseline (Day -2 [within -48 hrs of APT start]), Day 0 (within 4 hours after APT end), Day 2 (48 [± 6] hrs of APT start), Day 30 (± 5 days), Day 90 (± 10 days) and Day 365 (± 14 days)

Title

Change From Baseline in Tricuspid Annular Plane Systolic Excursion (TAPSE) at Days 0, 2, 30, 90, and 365, as Assessed by Echocardiograph

Description

The extent of displacement of the tricuspid valves, termed as TAPSE was measured at specified timepoints using echocardiogram.

Time Frame

Baseline (Day -2 [within -48 hrs of APT start]), Day 0 (within 4 hours after APT end), Day 2 (48 [± 6] hrs of APT start), Day 30 (± 5 days), Day 90 (± 10 days) and Day 365 (± 14 days)

Title

Change From Baseline in Estimated Right Ventricular Systolic Pressure (RVSP) at Days 0, 2, 30, 90, and 365, as Assessed by Echocardiograph

Description

RVSP was measured at specified timepoints using echocardiogram.

Time Frame

Baseline (Day -2 [within -48 hrs of APT start]), Day 0 (within 4 hours after APT end), Day 2 (48 [± 6] hrs of APT start), Day 30 (± 5 days), Day 90 (± 10 days) and Day 365 (± 14 days)

Title

Percentage of Participants With Collapse of the Inferior Vena Cava (IVC) With Respiration at Days 0, 2, 30, 90, and 365, as Assessed by Echocardiograph

Description

The collapse of IVC was measured at specified timepoints using echocardiogram.

Time Frame

Baseline (Day -2 [within -48 hrs of APT start]), Day 0 (within 4 hours after APT end), Day 2 (48 [± 6] hrs of APT start), Day 30 (± 5 days), Day 90 (± 10 days) and Day 365 (± 14 days)

Title

Change From Baseline in Thrombus Burden by Miller Score as Assessed by Pulmonary Arteriogram (PAgram) at Day 0

Description

Time Frame

Baseline, Day 0 (within 4 hours after APT end)

Title

Change From Baseline in Thrombus Burden by Modified Miller Score as Assessed by CTA Scan at 48 ± 6 Hours After the Start of the APT Procedure

Description

Time Frame

From Baseline to 48 hrs ± 6 hours

Title

Change in 6 Minute Walk (6MW) Distance From Day 30 to Day 90 and 365

Description

Time Frame

Days 30, 90, 365

Title

Change in Borg Scale Score Before and After 6MW Distance Test at Days 30, 90, and 365

Description

Time Frame

Days 30, 90, and 365

Title

Number of Participants Who Received Oxygen Therapy

Description

Oxygen source is categorized as room air, nasal prongs, mask, and intubated.

Time Frame

Days 30, 90, and 365

Title

Change in Participant Reported Outcomes Measurement Information System Physical Function (PROMIS-PF) 6b Score From Day 30 to Day 365

Description

Time Frame

Day 30, Day 365

Title

Change in Pulmonary Embolism Quality of Life (PEmb-QOL) Score From Day 30 to Day 365

Description

Time Frame

Day 30, Day 365

Title

Number of Participants Who Encountered Technical Procedural Complications

Description

Technical complications associated with the use of the EKOS device will be recorded during catheter placement in the pulmonary artery and during the infusion procedure.

Time Frame

From device placement through Day 2

Title

Number of Participants With Symptomatic Recurrent Pulmonary Embolism (Per Adjudication)

Description

Time Frame

From Baseline up to Day 365

Title

Number of Participants Who Die Due to Any Cause

Description

Number of participants who died due to any cause for up to 365 days following the APT procedure, were reported.

Time Frame

From Baseline up to Day 365

Title

For Participants of UK Sites: Freedom From Major Harm Occurring Between Enrolment and 30 Days

Description

Time Frame

From Baseline up to Day 30

Title

For Participants of UK Sites:Change in EuroQual - 5 Dimensions - 5 Levels (EQ-5D-5L) Score From Day 30 to Day 365

Description

Time Frame

Day 30, Day 365

Title

For Participants of UK Sites: Time From Hospital Admission to Diagnosis of PE

Description

Time Frame

From Baseline through Day 3

Title

For Participants of UK Sites: Time From Diagnostic Computed Tomography (CT) Scan to Initiation of Treatment for PE

Description

Time Frame

From Baseline through Day 3

Title

For Participants of UK Sites: Time in Each Level of Care (Level 0 and 1; Level 2; and/or Level 3) Through Discharge

Description

Time Frame

From Baseline up to Hospital Discharge

Title

Healthcare Resource Utilization: Team Managing the Participant During Hospitalization - Number of Healthcare Professional (HCP) Specialties Involved. (UK Participants Only)

Description

Time Frame

From Baseline up to Day 365

Title

Healthcare Resource Utilization: Number of Healthcare Professionals (HCP) Visits for Venous Thromboembolism (VTE) After Hospitalization and During 12month Follow-up. (UK Participants Only)

Description

Time Frame

From Day 30 up to Day 365

Title

Healthcare Resource Utilization: Number of Healthcare Professionals (HCP) Visits for Venous Thromboembolism (VTE) After Hospitalization and During 12 Month Follow-up. (UK Participants Only)

Description

Time Frame

From Day 30 up to Day 365

Title

Healthcare Resource Utilization: Number of Hospital Re-Admissions After Hospitalization and During 12 Month Follow-up. (UK Participants Only)

Description

Number of Hospital Re-Admissions after hospitalization and during 12 month follow-up for UK Participants. Due to changes in the protocol, there were no subjects enrolled in the UK in Treatment Arm 4.

Time Frame

From Day 30 up to Day 365

Title

Healthcare Resource Utilization: Duration of Hospital Re-Admissions After Hospitalization and During 12 Month Follow-up. (UK Participants Only)

Description

Time Frame

From Day 30 through Day 365

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female greater than or equal to (≥) 18 years of age and less than or equal to (≤) 75 years of age. CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery). PE symptom duration ≤14 days. Submassive PE: RV/LV diameter ≥ 0.9 from CTA and hemodynamically stable. For Participants in UK Sites: Submassive PE: RV/LV diameter ≥ 0.9 from CTA, hemodynamically stable and an elevated biomarker. Must be treated within 48 hours of diagnosis of PE by CTA. Signed Informed consent obtained from subject or Legally Authorized Representative. 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. Major surgery within seven days of screening for study enrollment. Clinician deems the subject high-risk for catastrophic bleeding. History of heparin-induced thrombocytopenia (HIT). Catheter-based pharmacomechanical treatment for PE within 3 days of study enrollment. Systolic blood pressure (SBP) less than 90 mm Hg and/or use of vasopressors. Cardiac arrest (including pulseless electrical activity and asystole) requiring active cardiopulmonary resuscitation (CPR). Evidence of irreversible neurological compromise. Life expectancy < one year. For Participants in UK Sites: Life expectancy < one year or enrollment in hospice care. Use of thrombolytics or glycoprotein IIb/IIIa antagonists within 3 days prior to inclusion in the study. Out-of-Range Laboratory Values: Hematocrit < 30%, Platelets < 100 thousand/microliter (μL), International normalized ratio (INR) > 3. Creatinine outside the normal range for the treating institution. Participant is pregnant (positive pregnancy test; women of childbearing capacity must be tested) or breast feeding. Active cancer (metastatic, progressive, or treated within the last 6 months). Exception: participants with non-melanoma primary skin cancers are eligible to participate in the study. Known allergy, hypersensitivity, or thrombocytopenia from heparin, r-tPA, or iodinated contrast except for mild-moderate contrast allergies for which steroid pre-medication can be used. History of any hematologic disease potentially involving abnormal platelet number or function.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Victor Tapson, MD

Organizational Affiliation

Cedar Sinai, Los Angeles

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cedars Sinai

City

Beverly Hills

State/Province

California

ZIP/Postal Code

90211

Country

United States

Facility Name

Tallahassee Memorial Hospital

City

Tallahassee

State/Province

Florida

ZIP/Postal Code

32308

Country

United States

Facility Name

Florida Hospital Tampa

City

Tampa

State/Province

Florida

ZIP/Postal Code

33613

Country

United States

Facility Name

Piedmont Hospital

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30309

Country

United States

Facility Name

University Hospital

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30901

Country

United States

Facility Name

St. Vincent Medical Group

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46260

Country

United States

Facility Name

Jewish Hospital

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Facility Name

East Jefferson General Hospital

City

Metairie

State/Province

Louisiana

ZIP/Postal Code

70006

Country

United States

Facility Name

Detroit Medical Center

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Facility Name

Mount Carmel Health System

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43213

Country

United States

Facility Name

UPMC Hamot

City

Erie

State/Province

Pennsylvania

ZIP/Postal Code

16507

Country

United States

Facility Name

Lankenau Medical Center

City

Wynnewood

State/Province

Pennsylvania

ZIP/Postal Code

19096

Country

United States

Facility Name

Vanderbilt University Medical Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

Facility Name

Houston Methodist Sugarland Hospital

City

Richmond

State/Province

Texas

ZIP/Postal Code

77469

Country

United States

Facility Name

Inova Alexandria Hospital

City

Alexandria

State/Province

Virginia

Country

United States

Facility Name

Providence Sacred Heart Medical Center

City

Spokane

State/Province

Washington

ZIP/Postal Code

99204

Country

United States

Facility Name

Royal Devon & Exeter Hospital

City

Exeter

State/Province

England

ZIP/Postal Code

EX2 5DW

Country

United Kingdom

Facility Name

Medway Maritime Hospital

City

Gillingham

State/Province

England

ZIP/Postal Code

ME7 5NY

Country

United Kingdom

Facility Name

Royal Free Hospital

City

London

State/Province

England

ZIP/Postal Code

NW3 2QG

Country

United Kingdom

Facility Name

St. Thomas Hospital

City

London

State/Province

England

ZIP/Postal Code

SE1 7EH

Country

United Kingdom

Facility Name

Ninewells Hospital

City

Dundee

State/Province

Scotland

ZIP/Postal Code

DD1 9SY

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

32757658

Citation

Piazza G, Sterling KM, Tapson VF, Ouriel K, Sharp ASP, Liu PY, Goldhaber SZ. One-Year Echocardiographic, Functional, and Quality of Life Outcomes After Ultrasound-Facilitated Catheter-Based Fibrinolysis for Pulmonary Embolism. Circ Cardiovasc Interv. 2020 Aug;13(8):e009012. doi: 10.1161/CIRCINTERVENTIONS.120.009012. Epub 2020 Aug 6.

Results Reference

background

PubMed Identifier

30025734

Citation

Tapson VF, Sterling K, Jones N, Elder M, Tripathy U, Brower J, Maholic RL, Ross CB, Natarajan K, Fong P, Greenspon L, Tamaddon H, Piracha AR, Engelhardt T, Katopodis J, Marques V, Sharp ASP, Piazza G, Goldhaber SZ. A Randomized Trial of the Optimum Duration of Acoustic Pulse Thrombolysis Procedure in Acute Intermediate-Risk Pulmonary Embolism: The OPTALYSE PE Trial. JACC Cardiovasc Interv. 2018 Jul 23;11(14):1401-1410. doi: 10.1016/j.jcin.2018.04.008.

Results Reference

result

Learn more about this trial

Optimum Duration of Acoustic Pulse Thrombolysis Procedure in Acute Pulmonary Embolism

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Optimum Duration of Acoustic Pulse Thrombolysis Procedure in Acute Pulmonary Embolism (OPTALYSE PE)

Pulmonary Embolism and Thrombosis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial