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
NOT_YET_RECRUITING
Shenyang
Shenzhen Children's Hospital
NOT_YET_RECRUITING
Shenzhen
Fuwai Central China Cardiovascular Hospital
NOT_YET_RECRUITING
Zhengzhou
Contact Information
Primary
Ying Xia
xiaying@lifetechmed.com
86 13760184511
Time Frame
Start Date: 2021-07-13
Estimated Completion Date: 2025-12
Participants
Target number of participants: 82
Treatments
Experimental: IBS Angel
Iron Bioresorbable Scaffold System
Related Therapeutic Areas
Sponsors
Leads: Biotyx Medical (Shenzhen) Co., Ltd.

This content was sourced from clinicaltrials.gov

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