Status:
ENROLLING_BY_INVITATION
Balloon Pulmonary Angioplasty vs. Combined Approach With Pulmonary Artery Denervation in CTEPH: Effectiveness Comparison
Lead Sponsor:
Boris Dzudovic
Collaborating Sponsors:
Military Medical Academy, Belgrade, Serbia
Galen Research
Conditions:
Chronic Thromboembolic Pulmonary Hypertension
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
Brief Summary
This clinical trial investigates new treatment approaches for chronic thromboembolic pulmonary hypertension (CTEPH), a condition affecting the lungs' blood vessels. CTEPH often develops after repeated...
Detailed Description
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, le...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06209710
Start Date
April 1 2024
End Date
December 1 2025
Last Update
April 2 2024
Active Locations (1)
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1
Military Medical Academy
Belgrade, Serbia, 11000