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 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT01479218
Eligibility Criteria:
Inclusion Criteria:
1. Patients with a demonstrated patent ductus arteriosus
2. Female or male
3. Belonging to any ethnic group
4. Age between \> 6 months and 70 years
5. Body weight \> 6 kg \< 120 kg
Exclusion Criteria:
1. Associated congenital cardiac anomalies,
2. Body weight \< 6 Kilograms
General exclusion criteria
* presence of a known coagulation disorder
* thrombus at the position allocated for the implantation
* a vein thrombosis in the blood vessels chosen for the introducing system
* an active infection
* Nitinol intolerance (nickel or titanium)
* contrast medium intolerance
* patients who have a vascular system which is too small to admit the required sheath
* patients with pulmonary hypertension and pulmonary-vascular resistance of \>8 Woods Units or a lung - / systemic resistance (PR/SR) of \>0.4.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
70 Years
Study:
NCT01479218
Study Brief:
Protocol Section:
NCT01479218