Evaluating the Feasibility of Bioresorbable Iron-Based Covered Stent: A Clinical Trial
ConditionCoarctation of the Aorta
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-60
SponsorShubo Song
About this trial
A single-center, feasible clinical study to Evaluate the Treatment of Iron Bioresorbable Covered Scaffold System in patients with Coarctation of the Aorta Diseases
Eligibility criteria
Qualifiers
Patient must between 1 and 60 years old
diameter of adjacent normal segment of blood vessel×100% ) C：Peak velocity of echocardiographic Doppler in the CoA≥2.5m/s
The patients and their families have high compliance, sign the informed consent and willing to undergo 1-year follow-ups and related examinations.
The patient's expected lifespan is more than one year after successful treatment with the stent.
Disqualifiers
Patients with a history of iron overload or iron disorder, such as hereditary hemochromatosis, etc.
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.
Patients with known allergy to contrast agent, iron and its degradation products.
Patients with hemorrhagic disorders
Trial design
Treatments tested in this trial
- Implantation of Bioresorbable Iron-based Covered Aortic Stent
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Shubo Song
Lead sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor institution
Central China Fuwai Hospital of Zhengzhou University
Collaborator
Source ClinicalTrials.gov