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Early Catheter-directed Treatment of High Risk Pulmonary Embolism

NCT06672081 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2026-03-04

No results posted yet for this study

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

Interventions

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 Sheaths will be withdrawn immediately after catheter-based thrombectomy or after completion of catheter-directed local fibrinolysis, typically 5 to 10 hours after initiation.

DRUG

Conventional care

reperfusion treatment

Sponsors & Collaborators

  • Heart Center Leipzig at University of Leipzig

    collaborator UNKNOWN

  • Helios Health Institute GmbH

    collaborator OTHER

  • Leipzig Heart Science gGmbH

    lead OTHER

Principal Investigators

  • Karl Fengler, MD, Assoc. Prof. · Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology

  • Holger Thiele, MD. Prof. · Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-27
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06672081 on ClinicalTrials.gov