A Randomized Trial for Catheter-interventional Treatment of Intermediate High Risk Pulmonary Embolism
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- RV-LV-Ratio
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
RV-LV-Ratio
Time Frame: Day 1 after randomization
Change in right to left ventricular diameter ratio
clinical efficacy
Time Frame: Day 1 after randomization
quotient of systolic systemic blood pressure over heart rate and respiratory rate
Secondary Outcomes
- Mortality(1 day, 30 days, 1 year after randomization)
- Right heart failure(30 days and 1 year after randomization)
- pulmonary artery pressure(1 day, 30 days and 1 year after randomization)
- RV/LV-ratio(30 days and 1 year after randomization)
- TAPSE(1 day, 30 days and 1 year after randomization)
- difference in RA volume between the groups(1 day, 30 days and 1 year after randomization)
- Bleeding(1 day, 30 days and 1 year after randomization)
- Troponin and NT-proBNP(30 days and 1 year after randomization)