'Thrombectomy in High-Risk Pulmonary Embolism - Device Versus Thrombolysis Netherlands': TORPEDO-NL

NARecruitingINTERVENTIONAL
Enrollment

111

Participants

Timeline

Start Date

February 28, 2025

Primary Completion Date

January 31, 2028

Study Completion Date

January 31, 2029

Conditions
Pulmonary Embolism Acute
Interventions
DEVICE

Catheter-directed thrombectomy (CDT)

The intervention consists of immediate thrombectomy (thrombectomy with any approved device) without systemic/locally administered thrombolysis. Thrombectomy is performed via jugular or femoral venous access according to the instructions for use for the particular device. The catheter is advanced over a preplaced guidewire across the right heart into the pulmonary arteries to the location of proximal thrombus. Procedural therapeutic anticoagulation with heparin is administered. After removal of the dilator, the thrombus is extracted by controlled volume aspiration through an aspiration catheter using a syringe or dedicated aspiration system, with multiple aspirations performed as needed. Procedural objectives will be clearly stated prior to the intervention and patient's clinical and hemodynamic status and residual thrombus will guide the investigators to determine when to terminate the procedure. Treatment success is defined as clear evidence of right ventricular recompensation.

DRUG

thrombolysis therapy

Standard reperfusion treatment for high-risk PE patients is thrombolytic therapy, typically consisting of Alteplase, Urokinase, or Tenecteplase, with the idea of accelerated fragmentation of the thrombus by lytic medication given systemically.

Trial Locations (1)

2333ZA

RECRUITING

Leiden University Medical Centre, Leiden

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Dutch Heart Foundation

OTHER

collaborator

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

collaborator

Zorginstituut Nederland: The Health Care Insurance Board

UNKNOWN

lead

Leiden University Medical Center

OTHER