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recombinant tissue plasminogen activator

Phase 3

Pulmonary Embolism | Small molecule | Other |Boston Scientific Corporation|Last Updated: Jul 19, 2021

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment150
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01513759Submassive and Massive Pulmonary Embolism Treatment With Ultrasound Accelerated Thrombolysis TherapyPHASE3 COMPLETED 150Jun 7, 2012Feb 17, 2013Jul 19, 202122 United States
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Study Endpoints
Primary Endpoints
Change From Baseline in the Right Ventricle (RV) Diameter-to-Left Ventricle (LV) Diameter Ratio Within 48 +/- 6 Hours of Initiation of Therapy
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
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.

Secondary Endpoints
Change From Baseline in Pulmonary Artery Systolic Pressure at 48 Hours After Start of Therapy
Baseline, Hour 48 after initiation of therapy
Percentage of Participants With Symptomatic Recurrent Pulmonary Embolism (PE)
Baseline up to Day 30
Number of Participants Who Died Due to Any Cause
Baseline up to Day 30
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
EkoSonic® Endovascular SystemEXPERIMENTALParticipants 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.
Interventions
NameTypeDescription
recombinant tissue plasminogen activatorDRUGParticipants will receive 24 mg of r-tPA delivered via the EkoSonic Endovascular Device.
EKOS EkoSonic Endovascular SystemDEVICE24 mg of r-tPA will be delivered through the EkoSonic Endovascular System.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites22

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) * Massiv...

Countries:United States
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Competitive Landscape -Pulmonary Embolism 6 trials