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Balloon Pulmonary Angioplasty in Non-operable CTEPH Patients

NCT02964390 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-08-19

No results posted yet for this study

Summary

Balloon pulmonary angioplasty (BPA) emerged as a potential therapeutic option for non-operable patients with chronic thromboembolic pulmonary hypertension (CTEPH).

The aim of this study was to evaluate the safety and efficacy of BPA in patients disqualified from surgery or suffered from persistent CTEPH despite pulmonary endarterectomy.

This is a interventional study analyzing the benefits and the risk of BPA. Clinical evaluation, including: functional capacity, 6-minutes walking test, haemodynamics, biomarkers, cardiopulmonary exercise test, echocardiography, electrocardiography and QoL assessment with Short Form 36 (SF36) questionnaire was performed before the initiation therapy of BPA, and 3-6 months after last session of BPA.

Conditions

  • Chronic Thromboembolic Pulmonary Hypertension

Interventions

PROCEDURE

Balloon Pulmonary Angioplasty

Sponsors & Collaborators

  • Department of Pulmonary Circulation and Thromboembolic Diseases, Medical Center for Postgraduate Med

    lead OTHER

Principal Investigators

  • Marcin Kurzyna, MD,PhD · European Health Center Otwock

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2023-06-30
Completion
2023-12-31

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02964390 on ClinicalTrials.gov