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Early Catheter-directed Treatment of High Risk Pulmonary Embolism

ConditionPulmonary Embolism Acute Massive
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLeipzig Heart Science gGmbH

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

Disqualifiers

Contraindications for catheter-based treatment

Contraindications to systemic fibrinolytic treatment or anticoagulation*

Active, potentially life-threatening bleeding

Surgery within 24h before screening

Trial design

Design model

Parallel

Treatments tested in this trial

  • Early Catheter-Interventional Treatment

    Procedure/Surgery

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 Sheaths will be withdrawn immediately after catheter-based thrombectomy or after completion of catheter-directed local fibrinolysis, typically 5 to 10 hours after initiation.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

    Drug

    reperfusion treatment

Treatment groups

210 Participants
are divided into 2 treatment groups
Group A: conventional careActive comparator 1 intervention
Group B: Early Catheter-Interventional Treatment + conventional careExperimental treatment 2 interventions

Trial outcomes

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

Time frame
7 days

Secondary outcomes

1

All-cause mortality

All-cause mortality at day 7 after randomization

Time frame
7 days
2

PE-related mortality

PE-related mortality at day 7 after randomization

Time frame
7 days
3

Mortality (all-cause)

Mortality (all-cause) at day 30 after randomization

Time frame
30 days
4

Bail out therapy

Bail out therapy at day 7 after randomization

Time frame
7 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Leipzig Heart Science gGmbH

Lead sponsor

Heart Center Leipzig at University of Leipzig

Collaborator

Helios Health Institute GmbH

Collaborator

Source ClinicalTrials.gov
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