Early Catheter-directed Treatment of High Risk Pulmonary Embolism

Not Applicable

Recruiting

• Conditions: Pulmonary Embolism Acute Massive
• Interventions: Drug: Conventional care; Procedure: Early Catheter-Interventional Treatment

• Registration Number: NCT06672081
• Lead Sponsor: Leipzig Heart Science gGmbH

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-01
• Study First Submitted QC: 2024-11-01
• Study First Posted: 2024-11-04
• Study Start: 2024-12-27
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-24
• Last Update Posted: 2025-06-25
• Primary Completion: 2027-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 315

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional care	Conventional care	Patients in the conventional care group will receive guideline directed therapy including reperfusion treatment. If no clinically relevant hemodynamic improvement occurs, catheter-interventional treatment may be used as stated in the current ESC-guidelines
Early Catheter-Interventional Treatment + conventional care	Early Catheter-Interventional Treatment	Patients in this group 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. The choice of the catheter types and sizes will be left to the treating interventionalists' discretion.
Early Catheter-Interventional Treatment + conventional care	Conventional care	Patients in this group 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. The choice of the catheter types and sizes will be left to the treating interventionalists' discretion.

Primary Outcome Measures

Name	Time	Method
Composite endpoint of mortality (all-cause) and recurrent cardiac arrest or persistent / recurrent shock	7 days	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

Secondary Outcome Measures

Name	Time	Method
All-cause mortality	7 days	All-cause mortality at day 7 after randomization
PE-related mortality	7 days	PE-related mortality at day 7 after randomization
Mortality (all-cause)	30 days	Mortality (all-cause) at day 30 after randomization
Bail out therapy	7 days	Bail out therapy at day 7 after randomization
GUSTO moderate or severe bleeding	7 days	GUSTO moderate or severe bleeding up to 7 days after randomization
VA-ECMO use	7 days	VA-ECMO use between randomization and day 7 after randomization
Change in echocardiographic parameters	24 hours	Change in echocardiographic parameters (RV/LV ratio, RV-strain, TAPSE) 24h after randomization
Time to hemodynamic stabilization	30 days	Time to hemodynamic stabilization
Days of ICU stay	30 days	Days of ICU stay

Trial Locations

Locations (11)

Universitätsklinikum Freiburg; 🇩🇪 Bad Krozingen, Germany

Universitätsklinikum Bonn; 🇩🇪 Bonn, Germany

Universitätsklinikum Halle; 🇩🇪 Halle (Saale), Germany

SLK-Kliniken Heilbronn; 🇩🇪 Heilbronn, Germany

Universitätsklinikum Leipzig; 🇩🇪 Leipzig, Germany

Universitätsklinikum Mannheim; 🇩🇪 Mannheim, Germany

Schwarzwald-Baar-Klinikum; 🇩🇪 Villingen-Schwenningen, Germany

Rems-Murr-Kliniken; 🇩🇪 Winnenden, Germany

Helios Kliniken Wuppertal; 🇩🇪 Wuppertal, Germany

Asklepios Klinik St. Georg; 🇩🇪 Hamburg, Germany

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