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Catheter-interventional Treatment of Pulmonary Embolism (CATCH-PE)

Primary Purpose

Pulmonary Embolism

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
combined catheter-thrombectomy and local fibrinolysis
conventional treatment
Sponsored by
Heart Center Leipzig - University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Embolism

Eligibility Criteria

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

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

Sites / Locations

  • Heart Center Leipzig at University of LeipzigRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Combined interventional treatment

conventional treatment

Arm Description

Combined catheter-based fibrinolysis and thrombectomy plus conventional treatment

Conventional treatment

Outcomes

Primary Outcome Measures

RV-LV-Ratio
Change in right to left ventricular diameter ratio
clinical efficacy
quotient of systolic systemic blood pressure over heart rate and respiratory rate

Secondary Outcome Measures

Mortality
difference in mortality between the treatment groups
Right heart failure
difference in new onset right heart failure between the groups
pulmonary artery pressure
difference in estimated pulmonary artery pressure between the groups
RV/LV-ratio
difference in RV/LV-ratio
TAPSE
TAPSE as assessed by transthoracic echocardiogram
RA volume between the groups
RA volume between the groups
Bleeding
difference in BARC bleeding events between the groups
Troponin and NT-proBNP
difference in high-sensitivity Troponin T and NT-proBNP between the groups

Full Information

First Posted
June 16, 2022
Last Updated
July 9, 2022
Sponsor
Heart Center Leipzig - University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05456789
Brief Title
Catheter-interventional Treatment of Pulmonary Embolism
Acronym
CATCH-PE
Official Title
A Randomized Trial for Catheter-interventional Treatment of Intermediate High Risk Pulmonary Embolism
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 16, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Heart Center Leipzig - University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Combined interventional treatment
Arm Type
Experimental
Arm Description
Combined catheter-based fibrinolysis and thrombectomy plus conventional treatment
Arm Title
conventional treatment
Arm Type
Active Comparator
Arm Description
Conventional treatment
Intervention Type
Device
Intervention Name(s)
combined catheter-thrombectomy and local fibrinolysis
Intervention Description
combination of catheter-based thrombectomy with local pulmonary fibrinolysis plus conventional treatment
Intervention Type
Other
Intervention Name(s)
conventional treatment
Intervention Description
conventional treatment of pulmonary embolism
Primary Outcome Measure Information:
Title
RV-LV-Ratio
Description
Change in right to left ventricular diameter ratio
Time Frame
Day 1 after randomization
Title
clinical efficacy
Description
quotient of systolic systemic blood pressure over heart rate and respiratory rate
Time Frame
Day 1 after randomization
Secondary Outcome Measure Information:
Title
Mortality
Description
difference in mortality between the treatment groups
Time Frame
1 day, 30 days, 1 year after randomization
Title
Right heart failure
Description
difference in new onset right heart failure between the groups
Time Frame
30 days and 1 year after randomization
Title
pulmonary artery pressure
Description
difference in estimated pulmonary artery pressure between the groups
Time Frame
1 day, 30 days and 1 year after randomization
Title
RV/LV-ratio
Description
difference in RV/LV-ratio
Time Frame
30 days and 1 year after randomization
Title
TAPSE
Description
TAPSE as assessed by transthoracic echocardiogram
Time Frame
1 day, 30 days and 1 year after randomization
Title
RA volume between the groups
Description
RA volume between the groups
Time Frame
1 day, 30 days and 1 year after randomization
Title
Bleeding
Description
difference in BARC bleeding events between the groups
Time Frame
1 day, 30 days and 1 year after randomization
Title
Troponin and NT-proBNP
Description
difference in high-sensitivity Troponin T and NT-proBNP between the groups
Time Frame
30 days and 1 year after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karl Fengler
Phone
+493418651427
Email
Karl.Fengler@medizin.uni-leipzig.de
Facility Information:
Facility Name
Heart Center Leipzig at University of Leipzig
City
Leipzig
State/Province
Saxony
ZIP/Postal Code
04289
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karl Fengler
Phone
+493418651427
Email
karl.fengler@medizin.uni-leipzig.de

12. IPD Sharing Statement

Learn more about this trial

Catheter-interventional Treatment of Pulmonary Embolism

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