It is expected to treat congenital or acquired, non-diffuse stenosis of left and right pulmonary artery or pulmonary artery branches.
Conditions
Interventions
Sponsors
Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with pulmonary artery stenosis who signed an informed consent and were implanted with Pul-Stent® in premarket studies.
Exclusion criteria
Exclusion criteria: It is strictly prohibited for patients with the following possibilities: 1) Allergic to cobalt alloy; 2) pregnant; 3) Contraindications of antiplatelet and anticoagulant ther calcification of target vessels; 5) Contrast agent allergy; 6) Patients whose cardiopulmonary function cannot tolerate surgery; 7)Others had lesions that were not conducive to stent delivery or balloon dilation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of stent displacement, detachment and fracture;Vascular diameter change rate and pressure gradient in stent segment;Incidence of stent removal;The incidence of stent re-expansion;Incidence of thrombotic events requiring treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mortality rate; | — |
Countries
China
Contacts
Public ContactGao Wei
Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed