20
Participants
Start Date
April 1, 2024
Primary Completion Date
August 31, 2025
Study Completion Date
December 31, 2025
Balloon Pulmonary Angioplasty combined with Pulmonary Artery Denervation
Participants in the intervention arm will undergo a combination of Balloon Pulmonary Angioplasty (BPA) and Pulmonary Artery Denervation (PADN), as part of this phase 2/3 clinical trial. The trial aims to determine the optimal number of radiofrequency (RF) ablation points required for effective PADN based on pulmonary artery size or diameter. The BPA procedure addresses segmental and subsegmental thrombi masses through pulmonary artery dilation, while the PADN procedure involves the placement of a denervation catheter near the bifurcation of the main pulmonary artery. RF energy is selectively applied, and ablation points are determined based on individual patient characteristics and expected therapeutic effects. This unique approach seeks to customize the intervention to the patient's specific pulmonary anatomy, contributing to the overall effectiveness of the treatment strategy.
Balloon Pulmonary Angioplasty with Sham Pulmonary Artery Denervation
Participants receive Balloon Pulmonary Angioplasty (BPA) combined with a sham Pulmonary Artery Denervation (PADN) procedure. The sham PADN involves catheter placement mimicking the actual procedure without the application of radiofrequency energy
Military Medical Academy, Belgrade
Collaborators (1)
Military Medical Academy, Belgrade, Serbia
OTHER
Galen Research
UNKNOWN
Boris Dzudovic
OTHER