Balloon Pulmonary Angioplasty in Non-operable CTEPH Patients

August 18, 2021 updated by: Marcin Kurzyna, Department of Pulmonary Circulation and Thromboembolic Diseases, Medical Center for Postgraduate Med

Assessment of Safety and Efficacy of Balloon Pulmonary Angioplasty in Non-operable CTEPH Patients

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Chronic thromboembolic pulmonary hypertension (CTEPH) is a rare but potentially life-threatening disease of the pulmonary circulation. Management of CTEPH requires precise differential diagnosis, long life anticoagulation when confirmed and qualification for surgical treatment by an experienced multidisciplinary team. The gold standard of treatment in operable patients is pulmonary endarterectomy (PEA), which is highly effective in restoring functional status and improving life expectancy. Nevertheless, even in the leading CTEPH referral centres almost 50% patients remain on medical treatment alone, with grim perspectives regarding life quality and expectancy. Recently, balloon pulmonary angioplasty (BPA) has emerged as a promising new interventional option in non-operable CTEPH.

The development BPA was far from rapid. It took 13 years from the first case-report to the publication of a first series of 17 patients treated with BPA in Boston/US and another 13 years until the results of first European series of 20 patients has been reported from Oslo/Norway. In Poland BPA was started to perform in non-operable CTEPH patients in 2013, motivated by their expected poor prognosis, when compared to those to whom surgical PEA was offered.

The aim of this study is an analysis of efficacy and safety of BPA procedure.

The BPA is performed by two senior interventional specialist - cardiologist and radiologist with extensive experience in coronary, pulmonary and general vessel interventions supported by perfusion nurse. All patients undergoing BPA are given informed consent before the first BPA intervention. The limited experience with and experimental nature of BPA are emphasised to candidates.

A standard BPA procedure is typically performed from the right femoral vein, with anticoagulation of unfractionated heparin in periprocedural period. A long (70 or 90 cm) sheath is introduced into the pulmonary trunk with support of pigtail catheter. Selective and super-selective catheterisation of lobar arteries, segmental and when appropriate subsegmental arteries is performed to demonstrate variety of clots: "webs", "rings", "occlusions", "pouch" lesions and reduction of parenchymal opacification after injection of vascular contrast medium. Balloon catheters (diameter 1.25-6.0 mm) are positioned over the selected lesion and dilated for several seconds. Immediate selective angiography is performed after dilation to confirm satisfactory results which presented the improvement of contrast medium distribution and venous return. Control angiography is done to rule out residual stenosis or signs of vessel injury. Following BPA procedure, patients are moved to ICU for 48 h surveillance.

Right before the initiation of BPA and during 3-6 months after last session, a full workup is made, including: World Health Organization (WHO) functional class, 6-minute walking test (6MWT), concentration of biomarkers (NT-proBNP, Troponin T, sST2), cardiopulmonary exercise test, echocardiography, electrocardiography and right heart catheterization including measurements of right atrial pressure (RAP), pulmonary artery pressure (PAP), pulmonary capillary wedge pressure (PCWP), cardiac output (CO), cardiac index (CI), pulmonary vascular resistance (PVR), mixed venous oxygenation (MVsat.O2) and systemic oxygenation (AOsatO2). Additionally patients fill in the Short Form 36 (SF36) quality of life questionnaire before initiation of BPA and 3-6 months after last session.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • diagnosed with CTEPH according to ESC Guidelines
  • WHO functional capacity ≥ II
  • documented period of anticoagulation > 6 months after the episode of Pulmonary Embolism,

Exclusion Criteria:

  • age < 18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Balloon Pulmonary Angioplasty
This arm includes patients qualified to BPA procedure. They have a baseline workup performed before the initiation of BPA treatment and had a follow up examination from 3 to 6 months after the last BPA session.
Procedure: Balloon Pulmonary Angioplasty
Other Names:
  • BPA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of BPA procedure.
Time Frame: From initiation of BPA to 3-6 months after last session
Surveillance of complications including: vessel injury, desaturation, cough, mild hemoptysis (<50ml), severe hemoptysis (>50ml), reperfusion pulmonary injury, death.
From initiation of BPA to 3-6 months after last session
Improvement of haemodynamics caused by series of BPA.
Time Frame: From initiation of BPA to 3-6 months after last session
Measurements taken during right heart catheterization in at least 25 patients with accomplished interventional treatment of BPA. The measurements will include pulmonary artery pressure - PAP [mmHg].
From initiation of BPA to 3-6 months after last session
Improvement of functional capacity caused by series of BPA.
Time Frame: From initiation of BPA to 3-6 months after last session.
Examined using World Health Organization (WHO) functional capacity classification is evaluated by physician in every patient, on admission and follow up.
From initiation of BPA to 3-6 months after last session.
Improvement of NT-proBNP caused by series of BPA.
Time Frame: From initiation of BPA to 3-6 months after last session.
Baseline measurements of the concentration of NT-proBNP [pg/ml] in at least 25 subjects who accomplished their invasive treatment.
From initiation of BPA to 3-6 months after last session.
Improvement of six minutes walk test caused by series of BPA.
Time Frame: From initiation of BPA to 3-6 months after last session.
Six minutes walking test - 6MWT is performed according to European Society of Cardiology (ESC) guidelines. The baseline distance [meters] covered during the 6MWT will be compared to the follow up value in patients (at least 25) who accomplished their invasive treatment of BPA.
From initiation of BPA to 3-6 months after last session.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Marcin Kurzyna, MD,PhD, European Health Center Otwock

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

September 6, 2016

First Submitted That Met QC Criteria

November 13, 2016

First Posted (Estimate)

November 16, 2016

Study Record Updates

Last Update Posted (Actual)

August 19, 2021

Last Update Submitted That Met QC Criteria

August 18, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 002 (University of CT Health Center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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