Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:48 PM
Ignite Modification Date:
2025-12-24 @ 4:48 PM
NCT ID:
NCT02637050
Eligibility Criteria:
Inclusion Criteria:
* Female and male patients ≥ 18 years of age, diagnosed with CTEPH regardless of the current treatment
* Availability of a signed informed consent
* WHO Pulmonary Hypertension clinical classification Group IV (CTEPH):
1. Right heart catheterization (RHC) results that are in line with both of the following haemodynamic levels:
* Mean pulmonary arterial pressure (PAP) ≥ 25 mmHg at rest
* Pulmonary arterial wedge pressure (PAWP) ≤ 15 mmHg
2. Confirmation of CTEPH diagnosis by one of the following as recommended by standard guidelines:
* At least 1 (segmental) perfusion defect(s) in ventilation/perfusion (V/Q) scan or
* Pulmonary artery obstruction seen by MDCT (multidetector computed tomography) angiography or
* Pulmonary artery obstruction seen by conventional pulmonary cineangiography (In case of suspicion/diagnosis of 'sub-acute' Pulmonary Embolism: Patients who are treated with anti-coagulation for at least 3 months before diagnosis of CTEPH)
Exclusion Criteria:
* Patients with an underlying medical disorder with an anticipated life expectancy less than 6 months
* Any medical condition which, in the opinion of the investigator, could jeopardize the safety of the patient or his/her compliance in the study, or otherwise make the patient inappropriate for study participation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02637050
Study Brief:
Protocol Section:
NCT02637050