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

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 Overview

• Status: Recruiting
• Conditions: Pulmonary Embolism Acute Massive
• Intervention / Treatment: Drug: Conventional care; Procedure: Early Catheter-Interventional Treatment

• Study Type: Interventional
• Enrollment (Estimated): 210
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Holger Thiele, MD, Prof. Dr.; Email: holger.thiele@medizin.uni-leipzig.de
• Study Contact Backup: Name: Karl Fengler, MD, Assoc. Prof.; Phone Number: +49 341 865-1426; Email: karl.fengler@medizin.uni-leipzig.de

Study Locations

• Germany
  • Bad Krozingen, Germany, 79189
    • Recruiting
    • Universitatsklinikum Freiburg
    • Contact: Elias Noory, MD
  • Bautzen, Germany, 02625
    • Recruiting
    • Oberlausitzklinikum Bautzen, Medizinische Klinik I
    • Contact: Dr. med. Servi R. Ada, Dr. med.; Phone Number: 03591 36377288; Email: ServiRemzi.Ada@Oberlausitz-Kliniken.de
    • Contact: Prof. Dr. Steffen Schön, Prof. Dr.; Phone Number: 03591 36377143; Email: Steffen.Schoen@Oberlausitz-Kliniken.de
  • Bonn, Germany, 53127
    • Recruiting
    • Universitatsklinikum Bonn
    • Contact: Georg Nickenig, MD
  • Düsseldorf, Germany, 40225
    • Recruiting
    • Universitätsklinik Düsseldorf, Klinik für Kardiologie, Pneumologie und Angiologie
    • Contact: Dr. med. Lucas Busch Busch, Dr. med.; Phone Number: +49 2118108753; Email: HansLucas.Busch@med.uni-duesseldorf.de
  • Erfurt, Germany, 99089
    • Recruiting
    • HELIOS Klinikum Erfurt
    • Contact: Prof. Dr. Alexander Lauten, Prof. Dr.; Phone Number: +49 361 781 2481; Email: alexander.lauten@helios-gesundheit.de
  • Frankfurt am Main, Germany, 60590
    • Recruiting
    • Universitätsklinikum Frankfurt, Med. Klinik III - Kardiologie, Angiologie
    • Contact: PD Dr. med. Robert Stöhr, PD Dr. med.; Phone Number: +49 69630185884; Email: robert.stoehr@unimedizin-ffm.de
  • Halle, Germany, 06120
    • Recruiting
    • Universitatsklinikum Halle
    • Contact: Alexander Vogt, MD
  • Hamburg, Germany, 20099
    • Recruiting
    • Asklepios Klinik St. Georg
    • Contact: Eike Tigges, MD
  • Heilbronn, Germany, 74078
    • Recruiting
    • SLK-Kliniken Heilbronn
    • Contact: Markus Hennersdorf, MD
  • Kaiserslautern, Germany, 67655
    • Recruiting
    • Westpfalz-Klinikum GmbH, Klinik für Innere Medizin 2
    • Contact: Prof. Dr. med. Burghard Schumacher, Prof. Dr. med.; Phone Number: +49 631 2031079; Email: bschumacher@westpfalz-klinikum.de
  • Leipzig, Germany, 04103
    • Recruiting
    • Universitätsklinikum Leipzig
    • Contact: Karsten Lenk, MD
  • Leipzig, Germany, 04289
    • Recruiting
    • Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
    • Contact: Karl Fengler, MD
  • Mannheim, Germany, 68167
    • Recruiting
    • Universitätsklinikum Mannheim
    • Contact: Ibrahim Akin, MD
  • Nuremberg, Germany, 90471
    • Recruiting
    • Klinik für Innere Medizin 8 Schwerpunkt Kardiologie Universitätsklinik der Paracelsus Medizinischen Privatuniversität Klinikum Nürnberg I Campus Süd
    • Contact: Dr. med. Simon Roth, Dr. med.; Phone Number: +49 911398118722; Email: Simon.Roth@klinikum-nuernberg.de
  • Ulm, Germany, 89081
    • Recruiting
    • Bundeswehrkrankenhaus Ulm, Abteilung I - Innere Medizin, Schwerpunkt Kardiologie
    • Contact: Dr. med. Jakob Lindner, Dr. med.; Phone Number: +49 731 171031013; Email: jakob1Lindner@bundeswehr.org
  • Villingen-Schwenningen, Germany, 78052
    • Recruiting
    • Schwarzwald-Baar-Klinikum
    • Contact: Sebastian Ewen, MD
  • Winnenden, Germany, 71364
    • Recruiting
    • Rems-Murr-Kliniken
    • Contact: Dirk Mühlberger, MD
  • Wuppertal, Germany, 42117
    • Recruiting
    • Helios Kliniken Wuppertal
    • Contact: Alexander Wolf, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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

2. Age ≥18 years

Exclusion Criteria:

1. Contraindications for catheter-based treatment

2. Contraindications to systemic fibrinolytic treatment or anticoagulation*

   1. Active, potentially life-threatening bleeding
   2. Surgery within 24h before screening
   3. Cranial or spinal surgery within 14d before screening
   4. Stroke within 14d before screening
   5. Intracranial tumor
   6. Any condition not listed here but estimated as clinically relevant as judged by the treating investigator

3. Pregnancy

   • Patients with contraindications to systemic fibrinolysis or anticoagulation can be enrolled in a third study arm (registry) and undergo catheter-directed therapy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: conventional care; 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	Drug: Conventional care; reperfusion treatment
Experimental: Early Catheter-Interventional Treatment + conventional care; 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.	Drug: Conventional care; reperfusion treatment; Procedure: Early Catheter-Interventional 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 followingrecurrent cardiac arrest orpersistent / 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	All-cause mortality at day 7 after randomization	7 days
PE-related mortality	PE-related mortality at day 7 after randomization	7 days
Mortality (all-cause)	Mortality (all-cause) at day 30 after randomization	30 days
Bail out therapy	Bail out therapy at day 7 after randomization	7 days
GUSTO moderate or severe bleeding	GUSTO moderate or severe bleeding up to 7 days after randomization	7 days
VA-ECMO use	VA-ECMO use between randomization and day 7 after randomization	7 days
Change in echocardiographic parameters	Change in echocardiographic parameters (RV/LV ratio, RV-strain, TAPSE) 24h after randomization	24 hours
Days of ICU stay	Days of ICU stay	30 days
Time to hemodynamic stabilization	Time to hemodynamic stabilization	30 days

Collaborators and Investigators

• Sponsor: Leipzig Heart Science gGmbH
• Collaborators: Heart Center Leipzig at University of Leipzig; Helios Health Institute GmbH
• Investigators: 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

Study record dates

Study Major Dates

• Study Start (Actual): December 27, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: November 1, 2024
• First Submitted That Met QC Criteria: November 1, 2024
• First Posted (Actual): November 4, 2024

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: pulmonary embolism; early catheter-directed treatment
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Pulmonary Embolism
• Other Study ID Numbers: 2024-0124

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No