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Recruiting NCT06672081

Early Catheter-directed Treatment of High Risk Pulmonary Embolism

No phase Interventional Pulmonary Embolism Acute Massive

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Early Catheter-Interventional Treatment, Conventional care.
Who it may be relevant to
Registry conditions: Pulmonary Embolism Acute Massive. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized Trial for Early Catheter-directed Treatment of High Risk Pulmonary Embolism

Overview

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

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.Tran
  • Drug Conventional care
    reperfusion treatment

Primary outcome measures

  • Composite endpoint of mortality (all-cause) and recurrent cardiac arrest or persistent / recurrent shock [Time frame: 7 days]
Secondary outcome measures (9)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Germany · 18 centers
  • Universitätsklinikum Freiburg — Bad Krozingen
  • Oberlausitzklinikum Bautzen, Medizinische Klinik I — Bautzen
  • Universitätsklinikum Bonn — Bonn
  • Universitätsklinik Düsseldorf, Klinik für Kardiologie, Pneumologie und Angiologie — Düsseldorf
  • HELIOS Klinikum Erfurt — Erfurt
  • Universitätsklinikum Frankfurt, Med. Klinik III - Kardiologie, Angiologie — Frankfurt am Main
  • Universitätsklinikum Halle — Halle
  • Asklepios Klinik St. Georg — Hamburg
  • … and 10 more centers

Identifiers

NCT: NCT06672081 · 2024-0124

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗