Early Catheter-directed Treatment of High Risk Pulmonary Embolism
CATCH-PE II
A Randomized Trial for Early Catheter-directed Treatment of High Risk Pulmonary Embolism
1 other identifier
interventional
210
1 country
18
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2024
Typical duration for not_applicable
18 active sites
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
November 1, 2024
CompletedFirst Posted
Study publicly available on registry
November 4, 2024
CompletedStudy Start
First participant enrolled
December 27, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
March 4, 2026
March 1, 2026
2.5 years
November 1, 2024
March 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Composite endpoint of mortality (all-cause) and recurrent cardiac arrest or persistent / recurrent shock
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
7 days
Secondary Outcomes (9)
All-cause mortality
7 days
PE-related mortality
7 days
Mortality (all-cause)
30 days
Bail out therapy
7 days
GUSTO moderate or severe bleeding
7 days
- +4 more secondary outcomes
Study Arms (2)
conventional care
ACTIVE COMPARATORPatients 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
EXPERIMENTALPatients 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.
Interventions
reperfusion treatment
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.
Eligibility Criteria
You may qualify if:
- Pulmonary embolism as confirmed by CT angiogram with high mortality risk as defined by ESC guidelines:
- a) 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
You may not qualify if:
- 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Leipzig Heart Science gGmbHlead
- Heart Center Leipzig at University of Leipzigcollaborator
- Helios Health Institute GmbHcollaborator
Study Sites (18)
Universitätsklinikum Freiburg
Bad Krozingen, 79189, Germany
Oberlausitzklinikum Bautzen, Medizinische Klinik I
Bautzen, 02625, Germany
Universitätsklinikum Bonn
Bonn, 53127, Germany
Universitätsklinik Düsseldorf, Klinik für Kardiologie, Pneumologie und Angiologie
Düsseldorf, 40225, Germany
HELIOS Klinikum Erfurt
Erfurt, 99089, Germany
Universitätsklinikum Frankfurt, Med. Klinik III - Kardiologie, Angiologie
Frankfurt am Main, 60590, Germany
Universitätsklinikum Halle
Halle, 06120, Germany
Asklepios Klinik St. Georg
Hamburg, 20099, Germany
SLK-Kliniken Heilbronn
Heilbronn, 74078, Germany
Westpfalz-Klinikum GmbH, Klinik für Innere Medizin 2
Kaiserslautern, 67655, Germany
Universitätsklinikum Leipzig
Leipzig, 04103, Germany
Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
Leipzig, 04289, Germany
Universitätsklinikum Mannheim
Mannheim, 68167, Germany
Klinik für Innere Medizin 8 Schwerpunkt Kardiologie Universitätsklinik der Paracelsus Medizinischen Privatuniversität Klinikum Nürnberg I Campus Süd
Nuremberg, 90471, Germany
Bundeswehrkrankenhaus Ulm, Abteilung I - Innere Medizin, Schwerpunkt Kardiologie
Ulm, 89081, Germany
Schwarzwald-Baar-Klinikum
Villingen-Schwenningen, 78052, Germany
Rems-Murr-Kliniken
Winnenden, 71364, Germany
Helios Kliniken Wuppertal
Wuppertal, 42117, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Karl Fengler, MD, Assoc. Prof.
Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
- STUDY CHAIR
Holger Thiele, MD. Prof.
Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
Central Study Contacts
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
November 1, 2024
First Posted
November 4, 2024
Study Start
December 27, 2024
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
June 30, 2027
Last Updated
March 4, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share