Clinical trial NCT06672081: Early Catheter-directed Treatment of High Risk Pulmonary Embolism
Official title: A Randomized Trial for Early Catheter-directed Treatment of High Risk Pulmonary Embolism
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Embolism Acute Massive
Keywords: pulmonary embolism
early catheter-directed treatment
Lead sponsor: Leipzig Heart Science gGmbH
Sponsor class: OTHER
Collaborators: name: Heart Center Leipzig at University of Leipzig
name: Helios Health Institute GmbH
First posted: 2024-11-04
Enrollment: 315
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Composite endpoint of mortality (all-cause) and recurrent cardiac arrest or persistent / recurrent shock
timeFrame: 7 days
Secondary outcomes:
measure: All-cause mortality
timeFrame: 7 days
measure: PE-related mortality
timeFrame: 7 days
measure: Mortality (all-cause)
timeFrame: 30 days
measure: Bail out therapy
timeFrame: 7 days
measure: GUSTO moderate or severe bleeding
timeFrame: 7 days
measure: VA-ECMO use
timeFrame: 7 days
measure: Change in echocardiographic parameters
timeFrame: 24 hours
measure: Days of ICU stay
timeFrame: 30 days
measure: Time to hemodynamic stabilization
timeFrame: 30 days
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Asklepios Klinik St. Georg
city: Leipzig
country: Germany
facility: Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
Study officials:
affiliation: Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
name: Karl Fengler, MD, Assoc. Prof.
role: STUDY_CHAIR
affiliation: Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
name: Holger Thiele, MD. Prof.
role: STUDY_CHAIR
References: