Early Catheter-directed Treatment of High Risk Pulmonary Embolism
A Randomized Trial for Early Catheter-directed Treatment of High Risk Pulmonary Embolism
Leipzig Heart Science gGmbH
210 participants
Dec 27, 2024
INTERVENTIONAL
Conditions
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
Eligibility
Inclusion Criteria3
- 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 Criteria10
- 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.
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Interventions
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 Sheaths will be withdrawn immediately after catheter-based thrombectomy or after completion of catheter-directed local fibrinolysis, typically 5 to 10 hours after initiation.
reperfusion treatment
Locations(18)
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NCT06672081