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Search / Trial NCT06209710

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

Launched by BORIS DZUDOVIC · Jan 15, 2024

Trial Information

Current as of June 26, 2025

Enrolling by invitation

Keywords

Balloon Pulmonary Angioplasty Pulmonary Artery Denervation Cteph

ClinConnect Summary

This clinical trial focuses on advancing our understanding and treatment of chronic thromboembolic pulmonary hypertension (CTEPH). CTEPH arises when blood clots in the lungs fail to fully dissolve, leading to the formation of fibrous masses that obstruct blood vessels, increase pulmonary blood pressure, and strain the heart's right ventricle.

The study's primary objective is to evaluate the combined use of two innovative treatments, Balloon Pulmonary Angioplasty (BPA) and Pulmonary Artery Denervation (PADN), in comparison to the standard treatment for CTEPH. BPA involves using a balloon to...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Written informed consent.
  • Age 18 - 80 years.
  • Diagnosis of chronic thromboembolic heart disease.
  • Mean pulmonary arterial pressure (mPAP) \>20 mmHg.
  • Pulmonary vascular resistance \>3 Wood units.
  • Presence of organized thrombus masses.
  • World Health Organization (WHO) functional class II to IV.
  • Exclusion Criteria:
  • Proximal organized thrombotic masses not suitable for Balloon Pulmonary Angioplasty (BPA) and Pulmonary Artery Denervation (PADN).
  • WHO functional class I
  • Additionally, participants can be excluded from the trial under the following circumstances:
  • Withdrawal of consent at any time.
  • Failure to complete the treatment as per protocols.
  • Protocol violations.

About Boris Dzudovic

Boris Dzudovic is a dedicated clinical trial sponsor committed to advancing medical research and improving patient outcomes through innovative clinical studies. With a strong emphasis on ethical practices and regulatory compliance, Boris Dzudovic collaborates with leading researchers and healthcare institutions to design and implement trials that address critical health challenges. His expertise in trial management and patient engagement ensures that studies are conducted efficiently while prioritizing participant safety and data integrity. Through a focus on collaboration and transparency, Boris Dzudovic aims to contribute significantly to the fields of medicine and healthcare.

Locations

Belgrade, , Serbia

Patients applied

0 patients applied

Trial Officials

Slobodan Obradovic, MD, PhD

Principal Investigator

Clinic of Cardiology, Military Medical Academy, Belgrade, Serbia

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported