Early Catheter-directed Treatment of High Risk Pulmonary Embolism (CATCH-PE II)

Leipzig Heart Science gGmbH

Status: Enrolling

Conditions: Pulmonary Embolism Acute Massive

Treatments: Procedure: Early Catheter-Interventional Treatment; Drug: Conventional care

Study type: Interventional

Funder types: Other

Identifiers

NCT06672081

2024-0124

Details and patient eligibility

About

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

Enrollment: 315 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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315 participants in 2 patient groups

conventional care

Active Comparator group

Description:

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

Treatment:

Drug: Conventional care

Early Catheter-Interventional Treatment + conventional care

Experimental group

Description:

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.

Treatment:

Drug: Conventional care

Procedure: Early Catheter-Interventional Treatment