Early Catheter-directed Treatment of High Risk Pulmonary Embolism

NCT ID: NCT06672081

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 315 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-27
• Study Completion Date: 2027-06-30

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

Conditions

Pulmonary Embolism Acute Massive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Conventional care

Intervention Type: DRUG

reperfusion treatment

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 Sheaths will be withdrawn immediately after catheter-based thrombectomy or after completion of catheter-directed local fibrinolysis, typically 5 to 10 hours after initiation.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.

Group Type: EXPERIMENTAL

Early Catheter-Interventional Treatment

Intervention Type: PROCEDURE

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 care

Intervention Type: DRUG

reperfusion treatment

Interventions

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.

Intervention Type: PROCEDURE

Conventional care

reperfusion treatment

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heart Center Leipzig at University of Leipzig

UNKNOWN

Sponsor Role: collaborator

Helios Health Institute GmbH

OTHER

Sponsor Role: collaborator

Leipzig Heart Science gGmbH

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karl Fengler, MD, Assoc. Prof.

Role: STUDY_CHAIR

Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology

Holger Thiele, MD. Prof.

Role: STUDY_CHAIR

Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology

Locations

Universitätsklinikum Freiburg

Bad Krozingen, , Germany

Site Status: RECRUITING

Universitätsklinikum Bonn

Bonn, , Germany

Site Status: RECRUITING

Universitätsklinikum Halle

Halle, , Germany

Site Status: RECRUITING

Asklepios Klinik St. Georg

Hamburg, , Germany

Site Status: RECRUITING

SLK-Kliniken Heilbronn

Heilbronn, , Germany

Site Status: RECRUITING

Universitätsklinikum Leipzig

Leipzig, , Germany

Site Status: RECRUITING

Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology

Leipzig, , Germany

Site Status: RECRUITING

Universitätsklinikum Mannheim

Mannheim, , Germany

Site Status: RECRUITING

Schwarzwald-Baar-Klinikum

Villingen-Schwenningen, , Germany

Site Status: RECRUITING

Rems-Murr-Kliniken

Winnenden, , Germany

Site Status: RECRUITING

Helios Kliniken Wuppertal

Wuppertal, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Karl Fengler, MD, Assoc. Prof.

Role: CONTACT

karl.fengler@medizin.uni-leipzig.de

+49 341 865-1426

Holger Thiele, MD, Prof. Dr.

Role: CONTACT

holger.thiele@medizin.uni-leipzig.de

Facility Contacts

Elias Noory, MD

Role: primary

Georg Nickenig, MD

Role: primary

Alexander Vogt, MD

Role: primary

Eike Tigges, MD

Role: primary

Markus Hennersdorf, MD

Role: primary

Karsten Lenk, MD

Role: primary

Karl Fengler, MD

Role: primary

Ibrahim Akin, MD

Role: primary

Sebastian Ewen, MD

Role: primary

Dirk Mühlberger, MD

Role: primary

Alexander Wolf, MD

Role: primary

Other Identifiers

2024-0124

Identifier Type: -

Identifier Source: org_study_id