111
Participants
Start Date
February 28, 2025
Primary Completion Date
January 31, 2028
Study Completion Date
January 31, 2029
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.
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.
RECRUITING
Leiden University Medical Centre, Leiden
Collaborators (1)
Dutch Heart Foundation
OTHER
ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
Zorginstituut Nederland: The Health Care Insurance Board
UNKNOWN
Leiden University Medical Center
OTHER