Balloon Pulmonary Angioplasty vs. Combined Approach With Pulmonary Artery Denervation in CTEPH: Effectiveness Comparison

PHASE2/PHASE3Enrolling by invitationINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

April 1, 2024

Primary Completion Date

August 31, 2025

Study Completion Date

December 31, 2025

Conditions
Chronic Thromboembolic Pulmonary Hypertension
Interventions
PROCEDURE

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.

PROCEDURE

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

Trial Locations (1)

11000

Military Medical Academy, Belgrade

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Military Medical Academy, Belgrade, Serbia

OTHER

collaborator

Galen Research

UNKNOWN

lead

Boris Dzudovic

OTHER

NCT06209710 - Balloon Pulmonary Angioplasty vs. Combined Approach With Pulmonary Artery Denervation in CTEPH: Effectiveness Comparison | Biotech Hunter | Biotech Hunter