Pulmonary Embolism Acute MassiveCATCH-PE IINCT06672081
Early Catheter-directed Treatment of High Risk Pulmonary Embolism
A study testing Early Catheter-Interventional Treatment and Conventional care in people with Pulmonary Embolism Acute Massive, run by Leipzig Heart Science gGmbH at 18 sites in Germany.
Trial summary
Prospective, multicenter, open label, randomized controlled clinical trial to compare the effects of an early catheter-directed treatment plus conventional care with conventional care in patients with high-risk pulmonary embolism Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism Acute Massive
- What is being tested?
- Early Catheter-Interventional Treatment and Conventional care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 18 sitesGermany
- Study dates
- 27 Dec 2024to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Pulmonary embolism as confirmed by CT angiogram with high mortality risk as defined by ESC guidelines:
- One of the following: i. Cardiac arrest or ii. obstructive shock (systolic BP <90 mmHg or vasopressors required to achieve a BP ≥90 mmHg despite an adequate filling status), in combination with end-organ hypoperfusion (cold, clammy skin, oliguria or serum lactate ≥2 mmol/L) and b) Signs of right-ventricular dysfunction on transthoracic echocardiogram or CT scan
- Age ≥18 years
Who cannot join
- Contraindications for catheter-based treatment
- Contraindications to systemic fibrinolytic treatment or anticoagulation*
- Active, potentially life-threatening bleeding
- Surgery within 24h before screening
- Cranial or spinal surgery within 14d before screening
- Stroke within 14d before screening
Show all 10Show fewer
- Intracranial tumor
- Any condition not listed here but estimated as clinically relevant as judged by the treating investigator
- Pregnancy
- Patients with contraindications to systemic fibrinolysis or anticoagulation can be enrolled in a third study arm (registry) and undergo catheter-directed therapy.
Trial locations and contacts
18 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Holger Thiele, MD, Prof. Dr. contact
18 sites in 1 country
Germany18 sites, 18 recruiting
- Recruiting
Universitätsklinikum Freiburg
Bad Krozingen, 79189
Elias Noory, MD
- Recruiting
Oberlausitzklinikum Bautzen, Medizinische Klinik I
Bautzen, 02625
Dr. med. Servi R. Ada, Dr. med., 03591 36377288, ServiRemzi.Ada@Oberlausitz-Kliniken.de
Prof. Dr. Steffen Schön, Prof. Dr., 03591 36377143, Steffen.Schoen@Oberlausitz-Kliniken.de
- Recruiting
Universitätsklinikum Bonn
Bonn, 53127
Georg Nickenig, MD
- Recruiting
Universitätsklinik Düsseldorf, Klinik für Kardiologie, Pneumologie und Angiologie
Düsseldorf, 40225
Dr. med. Lucas Busch Busch, Dr. med., +49 2118108753, HansLucas.Busch@med.uni-duesseldorf.de
- Recruiting
HELIOS Klinikum Erfurt
Erfurt, 99089
Prof. Dr. Alexander Lauten, Prof. Dr., +49 361 781 2481, alexander.lauten@helios-gesundheit.de
- Recruiting
Universitätsklinikum Frankfurt, Med. Klinik III - Kardiologie, Angiologie
Frankfurt am Main, 60590
PD Dr. med. Robert Stöhr, PD Dr. med., +49 69630185884, robert.stoehr@unimedizin-ffm.de
- Recruiting
Universitätsklinikum Halle
Halle, 06120
Alexander Vogt, MD
- Recruiting
Asklepios Klinik St. Georg
Hamburg, 20099
Eike Tigges, MD
- Recruiting
SLK-Kliniken Heilbronn
Heilbronn, 74078
Markus Hennersdorf, MD
- Recruiting
Westpfalz-Klinikum GmbH, Klinik für Innere Medizin 2
Kaiserslautern, 67655
Prof. Dr. med. Burghard Schumacher, Prof. Dr. med., +49 631 2031079, bschumacher@westpfalz-klinikum.de
- Recruiting
Universitätsklinikum Leipzig
Leipzig, 04103
Karsten Lenk, MD
- Recruiting
Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
Leipzig, 04289
Karl Fengler, MD
- Recruiting
Universitätsklinikum Mannheim
Mannheim, 68167
Ibrahim Akin, MD
- Recruiting
Klinik für Innere Medizin 8 Schwerpunkt Kardiologie Universitätsklinik der Paracelsus Medizinischen Privatuniversität Klinikum Nürnberg I Campus Süd
Nuremberg, 90471
Dr. med. Simon Roth, Dr. med., +49 911398118722, Simon.Roth@klinikum-nuernberg.de
- Recruiting
Bundeswehrkrankenhaus Ulm, Abteilung I - Innere Medizin, Schwerpunkt Kardiologie
Ulm, 89081
Dr. med. Jakob Lindner, Dr. med., +49 731 171031013, jakob1Lindner@bundeswehr.org
- Recruiting
Schwarzwald-Baar-Klinikum
Villingen-Schwenningen, 78052
Sebastian Ewen, MD
- Recruiting
Rems-Murr-Kliniken
Winnenden, 71364
Dirk Mühlberger, MD
- Recruiting
Helios Kliniken Wuppertal
Wuppertal, 42117
Alexander Wolf, MD
About this study
Official title: A Randomized Trial for Early Catheter-directed Treatment of High Risk Pulmonary Embolism
Prospective, multicenter, open label, randomized controlled clinical trial to compare the effects of an early catheter-directed treatment plus conventional care with conventional care in patients with high-risk pulmonary embolism
- Conditions
- Pulmonary Embolism Acute Massive
- Being tested
- Early Catheter-Interventional Treatment, Conventional care
- Keywords
- pulmonary embolism, early catheter-directed 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.
Early Catheter-Interventional TreatmentProcedure or surgery
Patients will undergo a catheter-interventional treatment within 60 min. after randomization. Fibrinolytic treatment will be prepared parallel to interventional treatment preparations to avoid any delay in its administration if clinically necessary. Catheter-interventional treatment may include any certified devices for the treatment of PE including aspiration thrombectomy, local fibrinolytic therapy, local ultrasound treatment as assistance to local fibrinolysis or any combination of these.Transfemoral venous access routes will be used for any catheter-directed treatment using sheath-sizes as recommended in the IFUs by the respective manufacturers. Sheaths will be withdrawn immediately after catheter-based thrombectomy or after completion of catheter-directed local fibrinolysis, typically 5 to 10 hours after initiation.
Conventional careDrug
reperfusion treatment
| Study group | Role | What they receive |
|---|---|---|
| conventional care | Active comparator | Patients in the conventional care group will receive guideline directed therapy including reperfusion treatment. If no clinically relevant hemodynamic improvement occurs, catheter-interventional treatment may be used as stated in the current ESC-guidelines Receives: Drug: Conventional care |
| Early Catheter-Interventional Treatment + conventional care | Experimental | Patients in this group will undergo a catheter-interventional treatment within 60 min. after randomization. Fibrinolytic treatment will be prepared parallel to interventional treatment preparations to avoid any delay in its administration, if clinically necessary. Catheter-interventional treatment may include any certified devices for the treatment of PE including aspiration thrombectomy, local fibrinolytic therapy, local ultrasound treatment as assistance to local fibrinolysis or any combination of these. Transfemoral venous access routes will be used for any catheter-directed treatment using sheath-sizes as recommended in the IFUs by the respective manufacturers. Sheaths will be withdrawn immediately after catheter-based thrombectomy or after completion of catheter-directed local fibrinolysis, typically 5 to 10 hours after initiation. The choice of the catheter types and sizes will be left to the treating interventionalists' discretion. Receives: Procedure: Early Catheter-Interventional Treatment; Drug: Conventional care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint of mortality (all-cause) and recurrent cardiac arrest or persistent / recurrent shock
- mortality (all-cause) up to 7 days after randomization and
- either one of the following
- recurrent cardiac arrest or
- persistent / recurrent shock (systolic BP <90 mmHg or vasopressors or ECMO required to achieve a systolic BP ≥90 mmHg, in combination with end-organ hypoperfusion (cold, clammy skin, oliguria or serum lactate ≥2 mmol/L) 24 hours after randomization
Measured: 7 days
Secondary outcomes (9)
All-cause mortality
All-cause mortality at day 7 after randomization
Measured: 7 days
PE-related mortality
PE-related mortality at day 7 after randomization
Measured: 7 days
Mortality (all-cause)
Mortality (all-cause) at day 30 after randomization
Measured: 30 days
Bail out therapy
Bail out therapy at day 7 after randomization
Measured: 7 days
GUSTO moderate or severe bleeding
GUSTO moderate or severe bleeding up to 7 days after randomization
Measured: 7 days
VA-ECMO use
VA-ECMO use between randomization and day 7 after randomization
Measured: 7 days
Change in echocardiographic parameters
Change in echocardiographic parameters (RV/LV ratio, RV-strain, TAPSE) 24h after randomization
Measured: 24 hours
Days of ICU stay
Days of ICU stay
Measured: 30 days
Time to hemodynamic stabilization
Time to hemodynamic stabilization
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start27 Dec 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Embolism Acute MassiveStudies 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
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leipzig Heart Science gGmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Heart Center Leipzig at University of Leipzig, Helios Health Institute GmbH
- Responsible party
- Sponsor
- Investigators
- Karl Fengler, MD, Assoc. Prof., Study chair, Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/CardiologyHolger Thiele, MD. Prof., Study chair, Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06672081
- Sponsor's protocol ID
- 2024-0124
- Acronym
- CATCH-PE II
- Status last verified
- Mar 2026
- First submitted
- 1 Nov 2024
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial for Early Catheter-directed Treatment of High Risk Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT06672081
- Acronym / sponsor ID
- CATCH-PE II / 2024-0124
- Conditions
- Pulmonary Embolism Acute Massive
- Keywords
- pulmonary embolism, early catheter-directed treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Leipzig Heart Science gGmbHUniversity, hospital or other
- Collaborators
- Heart Center Leipzig at University of Leipzig, Helios Health Institute GmbH
- Study start
- 27 Dec 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 4 Nov 2024 (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.
Prospective, multicenter, open label, randomized controlled clinical trial to compare the effects of an early catheter-directed treatment plus conventional care with conventional care in patients with 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 |
|---|---|---|
| conventional care | Active comparator | Drug: Conventional carePatients in the conventional care group will receive guideline directed therapy including reperfusion treatment. If no clinically relevant hemodynamic improvement occurs, catheter-interventional treatment may be used as stated in the current ESC-guidelines |
| Early Catheter-Interventional Treatment + conventional care | Experimental | Procedure: Early Catheter-Interventional Treatment, Drug: Conventional carePatients in this group will undergo a catheter-interventional treatment within 60 min. after randomization. Fibrinolytic treatment will be prepared parallel to interventional treatment preparations to avoid any delay in its administration, if clinically necessary. Catheter-interventional treatment may include any certified devices for the treatment of PE including aspiration thrombectomy, local fibrinolytic therapy, local ultrasound treatment as assistance to local fibrinolysis or any combination of these. Transfemoral venous access routes will be used for any catheter-directed treatment using sheath-sizes as recommended in the IFUs by the respective manufacturers. Sheaths will be withdrawn immediately after catheter-based thrombectomy or after completion of catheter-directed local fibrinolysis, typically 5 to 10 hours after initiation. The choice of the catheter types and sizes will be left to the treating interventionalists' discretion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pulmonary embolism as confirmed by CT angiogram with high mortality risk as defined by ESC guidelines:
- Age ≥18 years
Key exclusion criteria (10 listed)
- Contraindications for catheter-based treatment
- Contraindications to systemic fibrinolytic treatment or anticoagulation*
- Pregnancy
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 |
|---|---|---|
| Early Catheter-Interventional TreatmentPatients will undergo a catheter-interventional treatment within 60 min. after randomization. Fibrinolytic treatment will be prepared parallel to interventional treatment preparations to avoid any delay in its administration if clinically necessary. Catheter-interventional treatment may include any certified devices for the treatment of PE including aspiration thrombectomy, local fibrinolytic therapy, local ultrasound treatment as assistance to local fibrinolysis or any combination of these.Transfemoral venous access routes will be used for any catheter-directed treatment using sheath-sizes as recommended in the IFUs by the respective manufacturers. Sheaths will be withdrawn immediately after catheter-based thrombectomy or after completion of catheter-directed local fibrinolysis, typically 5 to 10 hours after initiation. | Procedure or surgery | Early Catheter-Interventional Treatment + conventional care |
| Conventional carereperfusion treatment | Drug | Early Catheter-Interventional Treatment + conventional care, conventional care |
Primary outcome
Composite endpoint of mortality (all-cause) and recurrent cardiac arrest or persistent / recurrent shock
Time frame: 7 days
1. mortality (all-cause) up to 7 days after randomization and 2. either one of the following 1. recurrent cardiac arrest or 2. persistent / recurrent shock (systolic BP <90 mmHg or vasopressors or ECMO required to achieve a systolic BP ≥90 mmHg, in combination with end-organ hypoperfusion (cold, clammy skin, oliguria or serum lactate ≥2 mmol/L) 24 hours after randomization
9 secondary outcomes
All-cause mortality
Time frame: 7 days
PE-related mortality
Time frame: 7 days
Mortality (all-cause)
Time frame: 30 days
Bail out therapy
Time frame: 7 days
GUSTO moderate or severe bleeding
Time frame: 7 days
VA-ECMO use
Time frame: 7 days
Change in echocardiographic parameters
Time frame: 24 hours
Days of ICU stay
Time frame: 30 days
Time to hemodynamic stabilization
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Holger Thiele, MD, Prof. Dr. contact
Karl Fengler, MD, Assoc. Prof. study chair
Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
Holger Thiele, MD. Prof. study chair
Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Catheter-Interventional Treatment and Conventional care in people with Pulmonary Embolism Acute Massive, run by Leipzig Heart Science gGmbH at 18 sites 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 3 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karl Fengler, MD, Assoc. Prof. (+49 341 865-1426, karl.fengler@medizin.uni-leipzig.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite endpoint of mortality (all-cause) and recurrent cardiac arrest or persistent / recurrent shock (time frame: 7 days). 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 4 Mar 2026.