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:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 1:26 AM
NCT ID:
NCT03456193
Eligibility Criteria:
Inclusion Criteria:
* Pulmonary vein stenosis involving at least one but up to all of the main pulmonary veins following initial treatment, including but not limited to balloon dilation, stenting, surgical repair or chemotherapy
* Focal pulmonary stenosis limited to the main pulmonary veins or their first or second order branches.
Exclusion Criteria:
* Diffuse pulmonary vein stenosis involving long segments of one or more pulmonary veins including diffuse stenosis into the second order pulmonary vein branches or beyond
* Significant underlying lung disease
* Irreversible pulmonary artery hypertension exceeding indexed 10 Woods units (WU)
* Irreversible multisystem organ failure; or additive effects of multiple systems affected making transplant survival unlikely
* Progressive systemic disease with early mortality (genetic/metabolic, idiopathic, syndromic)
* Morbid obesity (BMI\>30)
* Diabetes mellitus with evidence of end-organ damage
* Severe chromosomal, neurologic or syndromic abnormalities
* Active infection
* HIV or chronic hepatitis B or C infection
* Severe left ventricular dysfunction
* Malignancy within 5 years prior to transplant
* Severe renal or liver failure
* Inadequate social support for post-transplant management
* Recent history of illicit drug, tobacco or alcohol abuse despite trials/assistance to stop behavior
* Episode of acute rejection within the previous 6 months
* Post-transplant lymphoproliferative disease that has been within two years
* Evidence of large stroke with high risk for hemorrhagic conversion
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
17 Years
Study:
NCT03456193
Study Brief:
Protocol Section:
NCT03456193