Actively Recruiting
Evaluating the Feasibility of Bioresorbable Iron-Based Covered Stent: A Clinical Trial
Led by Shubo Song · Updated on 2026-01-05
10
Participants Needed
1
Research Sites
176 weeks
Total Duration
On this page
Sponsors
S
Shubo Song
Lead Sponsor
C
Central China Fuwai Hospital of Zhengzhou University
Collaborating Sponsor
AI-Summary
What this Trial Is About
A single-center, feasible clinical study to Evaluate the Treatment of Iron Bioresorbable Covered Scaffold System in patients with Coarctation of the Aorta Diseases
CONDITIONS
Official Title
Evaluating the Feasibility of Bioresorbable Iron-Based Covered Stent: A Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient must be between 1 and 60 years old
- Diagnosed with Coarctation of the Aorta or post-operative anastomotic stenosis after Coarctation surgery
- Meet at least one of the following: Pressure gradient of Coarctation in a calm state; degree of aortic stenosis of 50% or more; peak velocity of echocardiographic Doppler in the Coarctation area of 2.5 m/s or higher
- Patients and families must have high compliance, sign informed consent, and agree to 1-year follow-ups and examinations
- Expected lifespan of more than one year after successful stent treatment
- Reference vessel diameter between 4 and 16 mm
You will not qualify if you...
- History of iron overload or iron disorders such as hereditary hemochromatosis
- Cardiopulmonary function unable to tolerate surgery, including severe heart failure (NYHA Grade III or above) uncontrolled by treatment
- Known allergy to contrast agents, iron, or its degradation products
- Hemorrhagic disorders
- Contraindications to antiplatelet or anticoagulant therapy
- Thrombosis at the vascular wall of the target lesion or nearby locations
- Severe renal or hepatic insufficiency unsuitable for the procedure
- Target lesion previously treated with a stent
- Severe stenosis, excessive tortuosity, or anatomical abnormalities making stent delivery difficult
- Other conditions unfavorable for stent delivery or balloon expansion
- Participation in another clinical trial within 3 months prior to screening
- Any other condition deemed unsuitable for trial participation by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fuwai Central China Cardiovascular Hospital
Zhengzhou, Henan, China, 450000
Actively Recruiting
Research Team
S
Shubo Song, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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