Pulmonary EmbolismCATCH-PENCT05456789
Catheter-interventional Treatment of Pulmonary Embolism
A study testing combined catheter-thrombectomy and local fibrinolysis and conventional treatment in people with Pulmonary Embolism, run by Heart Center Leipzig - University Hospital at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- combined catheter-thrombectomy and local fibrinolysis and conventional treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 16 Jun 2022to 10 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- confirmed intermediate high-risk pulmonary embolism
- age >= 18 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Heart Center Leipzig at University of Leipzig
Leipzig, Saxony, 04289
About this study
Official title: A Randomized Trial for Catheter-interventional Treatment of Intermediate High Risk Pulmonary Embolism
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.
- Conditions
- Pulmonary Embolism
- Being tested
- combined catheter-thrombectomy and local fibrinolysis, conventional treatment
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Combined interventional treatment | Experimental | Combined catheter-based fibrinolysis and thrombectomy plus conventional treatment Receives: Device: combined catheter-thrombectomy and local fibrinolysis |
| conventional treatment | Active comparator | Conventional treatment Receives: Other: conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
RV-LV-Ratio
Change in right to left ventricular diameter ratio
Measured: Day 1 after randomization
clinical efficacy
quotient of systolic systemic blood pressure over heart rate and respiratory rate
Measured: Day 1 after randomization
Secondary outcomes (8)
Mortality
difference in mortality between the treatment groups
Measured: 1 day, 30 days, 1 year after randomization
Right heart failure
difference in new onset right heart failure between the groups
Measured: 30 days and 1 year after randomization
pulmonary artery pressure
difference in estimated pulmonary artery pressure between the groups
Measured: 1 day, 30 days and 1 year after randomization
RV/LV-ratio
difference in RV/LV-ratio
Measured: 30 days and 1 year after randomization
TAPSE
difference in TAPSE as assessed by transthoracic echocardiogram
Measured: 1 day, 30 days and 1 year after randomization
difference in RA volume between the groups
RA volume between the groups
Measured: 1 day, 30 days and 1 year after randomization
Bleeding
difference in BARC bleeding events between the groups
Measured: 1 day, 30 days and 1 year after randomization
Troponin and NT-proBNP
difference in high-sensitivity Troponin T and NT-proBNP between the groups
Measured: 30 days and 1 year after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start16 Jun 2022
- Primary completion10 Oct 2024
- Study completion10 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heart Center Leipzig - University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05456789
- Sponsor's protocol ID
- CATCH-PE
- Acronym
- CATCH-PE
- Status last verified
- Mar 2025
- First submitted
- 16 Jun 2022
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial for Catheter-interventional Treatment of Intermediate High Risk Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT05456789
- Acronym / sponsor ID
- CATCH-PE / CATCH-PE
- Conditions
- Pulmonary Embolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Heart Center Leipzig - University HospitalUniversity, hospital or other
- Study start
- 16 Jun 2022 (actual)
- Primary completion
- 10 Oct 2024 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 13 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined interventional treatment | Experimental | Device: combined catheter-thrombectomy and local fibrinolysisCombined catheter-based fibrinolysis and thrombectomy plus conventional treatment |
| conventional treatment | Active comparator | Other: conventional treatmentConventional treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- confirmed intermediate high-risk pulmonary embolism
- age >= 18 years
Key exclusion criteria (6 listed)
- high-risk pulmonary embolism
- contraindications for catheter-based treatment
- known allergy to anticoagulant treatment or fibrinolytics
- pregnancy
- participation in other randomized trials
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| combined catheter-thrombectomy and local fibrinolysiscombination of catheter-based thrombectomy with local pulmonary fibrinolysis plus conventional treatment | Device | Combined interventional treatment |
| conventional treatmentconventional treatment of pulmonary embolism | Other | conventional treatment |
Primary outcome
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
8 secondary outcomes
Mortality
Time frame: 1 day, 30 days, 1 year after randomization
Right heart failure
Time frame: 30 days and 1 year after randomization
pulmonary artery pressure
Time frame: 1 day, 30 days and 1 year after randomization
RV/LV-ratio
Time frame: 30 days and 1 year after randomization
TAPSE
Time frame: 1 day, 30 days and 1 year after randomization
difference in RA volume between the groups
Time frame: 1 day, 30 days and 1 year after randomization
Bleeding
Time frame: 1 day, 30 days and 1 year after randomization
Troponin and NT-proBNP
Time frame: 30 days and 1 year after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing combined catheter-thrombectomy and local fibrinolysis and conventional treatment in people with Pulmonary Embolism, run by Heart Center Leipzig - University Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RV-LV-Ratio (time frame: Day 1 after randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.