A Prospective, Multi-center, Single-arm Clinical Trial to Evaluate the Safety and Efficacy of Iron Bioresorbable Scaffold System (IBS Angel) in Patients With Pulmonary Artery Stenosis
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This is a prospective, multi-center, single-arm clinical trial to evaluate the safety and efficacy of Iron Bioresorbable Scaffold System (IBS Angel) in patients with pulmonary artery stenosis.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 14
Healthy Volunteers: f
View:
• Patients must between 1 and 14 years old.
• Patients who have congenital or secondary pulmonary artery stenosis (including pulmonary artery trunk, left pulmonary artery and right pulmonary artery), and meeting one of the following criteria:
• A: The pressure gradient across the stenosis ≥20mmHg measured by catheter; B: The degree of pulmonary artery stenosis ≥50% ( calculated by (diameter of adjacent normal segments - residual lumen diameter of the stenosis segment)/diameter of adjacent normal segments ×100%); C: The ratio of right ventricular systolic pressure to aortic systolic pressure ≥50%.
• Patients and whose family have high compliance, voluntarily participate in and sign the informed consent form, and complete the 2-year follow-up.
• Patients have life expectancy \>2 year after successful stent implantation.
Locations
Other Locations
China
The Second Xiangya Hospital of Central South University
NOT_YET_RECRUITING
Changsha
Children's Hospital of Chongqing Medical University
NOT_YET_RECRUITING
Chongqing
The People's Hospital of Gaozhou
RECRUITING
Gaozhou
Guangdong Provincial People's Hospital
RECRUITING
Guangzhou
Fuwai Yunnan Cardiovascular Hospital
NOT_YET_RECRUITING
Kunming
Shanghai Children's Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine
NOT_YET_RECRUITING
Shanghai
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
NOT_YET_RECRUITING
Shanghai
General Hospital of Northern Theater Command of Chinese People's Liberation Army