Nit-Occlud PDA Post-Approval Study

pfm medical

Status: Completed

Conditions: Patent Ductus Arteriosus (PDA)

Treatments: Device: PDA Coil

Study type: Observational

Funder types: Industry

Identifiers

NCT02100683

TP126

Details and patient eligibility

About

The Nit-Occlud PDA Post-Approval Study is designed to continue to evaluate the safety and effectiveness of the device in the post-approval phase.

Enrollment: 184 patients

Sex: All

Ages: 6 months to 21 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Angiographically confirmed PDA with minimum diameter < 4 mm.
• Weight is ≥ 5 kg.
• Age 6 months to 21 years.

Exclusion criteria

• Cardiac anomalies requiring surgery.
• Known bleeding or coagulation disorder.
• Febrile illness within 7 days of planned procedure.
• Pregnancy.
• Pulmonary hypertension with increased pulmonary vascular resistance (≥ 5 Wood Units).
• Hypersensitivity to contrast medium.
• Known nickel allergy.

Trial design

184 participants in 1 patient group

PDA Coil

Description:

Patients age 6 months to 21 years weighing \> 5kg with an angiographically confirmed PDA with a minimum diameter of \< 4 mm.

Treatment:

Device: PDA Coil