Catheter-interventional Treatment of Pulmonary Embolism
CATCH-PE
A Randomized Trial for Catheter-interventional Treatment of Intermediate High Risk Pulmonary Embolism
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2022
CompletedStudy Start
First participant enrolled
June 16, 2022
CompletedFirst Posted
Study publicly available on registry
July 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 10, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 10, 2024
CompletedMarch 14, 2025
March 1, 2025
2.3 years
June 16, 2022
March 12, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
RV-LV-Ratio
Change in right to left ventricular diameter ratio
Day 1 after randomization
clinical efficacy
quotient of systolic systemic blood pressure over heart rate and respiratory rate
Day 1 after randomization
Secondary Outcomes (8)
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
- +3 more secondary outcomes
Study Arms (2)
Combined interventional treatment
EXPERIMENTALCombined catheter-based fibrinolysis and thrombectomy plus conventional treatment
conventional treatment
ACTIVE COMPARATORConventional treatment
Interventions
combination of catheter-based thrombectomy with local pulmonary fibrinolysis plus conventional treatment
Eligibility Criteria
You may qualify if:
- confirmed intermediate high-risk pulmonary embolism
- age \>= 18 years
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Heart Center Leipzig at University of Leipzig
Leipzig, Saxony, 04289, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2022
First Posted
July 13, 2022
Study Start
June 16, 2022
Primary Completion
October 10, 2024
Study Completion
October 10, 2024
Last Updated
March 14, 2025
Record last verified: 2025-03