Catheter-interventional Treatment of Pulmonary Embolism

Heart Center Leipzig - University Hospital20 enrolled

Overview

Recent evidence supports the use of catheter-interventional techniques for the treatment of intermediate-high-risk pulmonary embolism. While there is evidence supporting the use of catheter-thrombectomy and alternatively local fibrinolysis, less is known on the combination of both approaches. The investigators aim to assess the effects of a combined interventional local fibrinolysis and catheter-thrombectomy and to compare them with conventional treatment in a cohort of patients with intermediate-high-risk pulmonary embolism.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pulmonary Embolism

Interventions

combined catheter-thrombectomy and local fibrinolysisDEVICE

combination of catheter-based thrombectomy with local pulmonary fibrinolysis plus conventional treatment

conventional treatmentOTHER

conventional treatment of pulmonary embolism

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * confirmed intermediate high-risk pulmonary embolism * age \>= 18 years Exclusion Criteria: * high-risk pulmonary embolism * contraindications for catheter-based treatment * known allergy to anticoagulant treatment or fibrinolytics * pregnancy * participation in other randomized trials * patients under legal supervision or guardianship

Locations (1)

Heart Center Leipzig at University of Leipzig

Leipzig, Saxony, Germany

Outcomes

Primary Outcomes

RV-LV-Ratio

Change in right to left ventricular diameter ratio

Time frame: Day 1 after randomization

clinical efficacy

quotient of systolic systemic blood pressure over heart rate and respiratory rate

Time frame: Day 1 after randomization

Secondary Outcomes

Mortality

difference in mortality between the treatment groups

Time frame: 1 day, 30 days, 1 year after randomization

Right heart failure

difference in new onset right heart failure between the groups

Time frame: 30 days and 1 year after randomization

pulmonary artery pressure

difference in estimated pulmonary artery pressure between the groups

Time frame: 1 day, 30 days and 1 year after randomization

RV/LV-ratio

difference in RV/LV-ratio

Time frame: 30 days and 1 year after randomization

TAPSE

difference in TAPSE as assessed by transthoracic echocardiogram

Time frame: 1 day, 30 days and 1 year after randomization

difference in RA volume between the groups

RA volume between the groups

Time frame: 1 day, 30 days and 1 year after randomization

Bleeding

Data from ClinicalTrials.gov

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