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NCT06090838: BALLOON

BPA in CTEPD Without PH

Recruiting now NA Last updated 19 October 2023
What this trial tests

NA trial testing Balloon Pulmonary Angioplasty (BPA) in Chronic Thromboembolic Disease in 60 participants. Currently enrolling.

Timeline
15 June 2023
Primary endpoint
31 October 2025
31 October 2027

Quick facts

Lead sponsorAmsterdam UMC, location VUmc
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment60
Start date15 June 2023
Primary completion31 October 2025
Estimated completion31 October 2027
Sites1 location across Netherlands

Drugs / interventions tested

Conditions studied

Sponsor

Amsterdam UMC, location VUmc — full company profile →

Who can join

Adults 18 to 80, any sex, with Chronic Thromboembolic Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this clinical trial is to assess the effect of Balloon Pulmonary Angioplasty (BPA) on quality of life and exercise capacity in patients with chronic tromboembolic pulmonary disease (CTEPD) without pulmonary hypertension (PH). The main question\[s\] it aims to answer are: * What is the effect of BPA on quality of life, measured with the PEmb-QoL-questionnaire, in patients with CTEPD without PH? * What is the effect of is the effect of BPA on exercise capacity in patients with CTEPD without PH? This study is a randomised clinical trial with cross-over design. Participants will be randomised in an intervention and a control group. At baseline, questionnaires and exercise tests will be perfomed in all patients. The intervention group will first receive BPA-treatment. After 6 months, all patients will fill in the questionaires and undergo the exercise tests. At this point the control group will also receive BPA-treatment. After 12 months the study outcomes will be measured in all participants with the same questionnaires and exercise tests. The total follow-up is 24 months.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Balloon Pulmonary Angioplasty (BPA)

Trials testing the same drug.

Other recruiting trials for Chronic Thromboembolic Disease

Currently open trials in the same condition.

Other Amsterdam UMC, location VUmc trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06090838.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing