A Clinical Trial to Evaluate the Safety and Efficacy of IBS Angel in Patients With Pulmonary Artery Stenosis
NCT ID: NCT04973540
Last Updated: 2021-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
82 participants
INTERVENTIONAL
2021-07-13
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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IBS Angel
Iron Bioresorbable Scaffold System
Iron Bioresorbable Scaffold System (IBS Angel)
Subjects in this arm will be implanted with IBS Angel.
Interventions
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Iron Bioresorbable Scaffold System (IBS Angel)
Subjects in this arm will be implanted with IBS Angel.
Eligibility Criteria
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Inclusion Criteria
2. 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%.
3. Patients and whose family have high compliance, voluntarily participate in and sign the informed consent form, and complete the 2-year follow-up.
4. Patients have life expectancy \>2 year after successful stent implantation.
Exclusion Criteria
2. Patients with cardiopulmonary function that cannot tolerate surgery, such as severe heart failure (NYHA Grade III and above) that cannot be controlled by active medical treatment.
3. Patients with known allergy to contrast agent, iron and its degradation products.
4. Patients with hemorrhagic disorders.
5. Patients with contraindications on antiplatelet agents and anticoagulant therapy.
6. Patients with thrombosis at the vascular wall of target lesion or the distal or proximal location.
7. Patients with known severe renal or hepatic insufficiency which are unsuitable for index procedure as per investigator judgement.
8. Previous stent implantation has been performed to treat the target lesion;
9. Patients with severe stenosis or excessive tortuosity in the targeted vessels, or anatomical abnormalities, making it difficult for device to reach the target lesion.
10. Other conditions that are not suitable for stent delivery or balloon expansion.
11. Patient who have already participated in another drug or medical device clinical trial that have not yet completed or withdrawn within 3 months before the screening period of this trial.
12. Patients who are not suitable for participating the trial as per investigator judgement.
1 Year
14 Years
ALL
No
Sponsors
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Biotyx Medical (Shenzhen) Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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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
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
Countries
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Central Contacts
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References
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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.
Other Identifiers
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IBS Angel-01
Identifier Type: -
Identifier Source: org_study_id