IRIS
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
Sponsor study identifier
interventional
82
1 country
10
Study Start
July 13, 2021
Actual (reported)Primary Completion
July 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 11, 2021
Actual (reported)July 13, 2021
Actual (reported)July 22, 2021
Actual (reported)July 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Rate of freedom from in-stent restenosis
Defined on a per target lesion basis.
12 months
Rate of procedural success
Defined on a per target lesion basis.
Immediately post-procedure
Rate of technical success
Immediately post-procedure
Rate of freedom from in-stent restenosis
1 month
Rate of freedom from in-stent restenosis
3 months
Rate of freedom from in-stent restenosis
6 months
Rate of device-related adverse events
1 month
Iron Bioresorbable Scaffold System
Subjects in this arm will be implanted with IBS Angel.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The Second Xiangya Hospital of Central South University
Changsha, China
Children's Hospital of Chongqing Medical University
Chongqing, China
The People's Hospital of Gaozhou
Gaozhou, China
Sun L, Li JJ, Xu YK, Xie YM, Wang SS, Zhang ZW. Initial status and 3-month results relating to the use of biodegradable nitride iron stents in children and the evaluation of right ventricular function. Front Cardiovasc Med. 2022 Aug 1;9:914370. doi: 10.3389/fcvm.2022.914370. eCollection 2022.
First Submitted
June 11, 2021
First Posted
July 22, 2021
Study Start
July 13, 2021
Actual (reported)Primary Completion
July 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Evaluation of Visceral Pleural Lumbar Lymphatic Drainage
Contact the study team to confirm eligibility.
Guangdong Provincial People's Hospital
Guangzhou, China
Fuwai Yunnan Cardiovascular Hospital
Kunming, China
Shanghai Children's Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China
General Hospital of Northern Theater Command of Chinese People's Liberation Army
Shenyang, China
Shenzhen Children's Hospital
Shenzhen, China
Fuwai Central China Cardiovascular Hospital
Zhengzhou, China
Study Completion
December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 19, 2021
Record last verified: 2021-11
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Source: ClinicalTrials.gov.
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