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A prospective, multi-center, single arm post-marketing study of the safety and efficacy of pul-Stent pulmonary artery stents in real-world clinical use

A prospective, multi-center, single arm post-marketing study of the safety and efficacy of pul-Stent pulmonary artery stents in real-world clinical use

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100052162
Enrollment
Unknown
Registered
2021-10-20
Start date
2021-11-01
Completion date
Unknown
Last updated
2022-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

It is expected to treat congenital or acquired, non-diffuse stenosis of left and right pulmonary artery or pulmonary artery branches

Interventions

Case series:No

Sponsors

Shanghai Children's Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients who are judged by the investigator to be suitable for implantation of pulmonary artery stents; 2. Patients (patients or immediate family members, guardians) agree to participate in this trial and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Those who are allergic to cobalt alloys; 2. Pregnancy; 3. Those with contraindications to antiplatelet and anticoagulant therapy; 4. Severe calcified lesions of target blood vessels; 5. Those who are allergic to contrast media; 6. Cardiopulmonary function can not tolerate surgery; 7. Other lesions that are not conducive to stent delivery or balloon dilation.

Design outcomes

Primary

MeasureTime frame
Restenosis rate of stent segment vessels;

Secondary

MeasureTime frame
Immediate postoperative success rate;Restenosis rate of stent segment vessels;Incidence of stent fracture;Incidence of stent re-expansion;Incidence of stent thrombosis;

Countries

China

Contacts

Public ContactGao Wei

Shanghai Children's Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine

davidgao1963@163.com+86 18930830812

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026