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Recruiting NCT07316855

Evaluating the Feasibility of Bioresorbable Iron-Based Covered Stent: A Clinical Trial

No phase Interventional Coarctation of the Aorta

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Implantation of Bioresorbable Iron-based Covered Aortic Stent.
Who it may be relevant to
Registry conditions: Coarctation of the Aorta. Basic parameters: 1 year — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Safety and Efficacy of Bioresorbable Iron-Based Covered Stent System for the Treatment of Coarctation of the Aorta: A Single-Center Clinical Study

Overview

A single-center, feasible clinical study to Evaluate the Treatment of Iron Bioresorbable Covered Scaffold System in patients with Coarctation of the Aorta Diseases

Detailed description

There is a feasibility study. Ten subjects are intended to participate in this study and without control group. The Iron Bioresorbable Covered Scaffold System will be implanted surgically. Follow-up will be conducted at 1 month, 3 months, 6 months and 12 months post-procedure. The primary endpoint is the rate of no restenosis of the stent at 12 months post-procedure \[Defined on a per target lesion basis\]

Interventions

  • Device Implantation of Bioresorbable Iron-based Covered Aortic Stent
    A novel bioresorbable iron-based covered stent for coarctation of the aorta

Primary outcome measures

  • 1.Rate of no stent restenosis[Defined on a per target lesion basis] [Time frame: at 12 months post-procedure]
  • 2.Acute Procedure Success [Time frame: after the stent is delivered to the target lesion site and expanded during the procedure]
Secondary outcome measures (8)
  • 1.Acute Technical Success [Time frame: after the stent is delivered to the target lesion site and expanded during the procedure]
  • 2.Rate of no stent restenosis [Time frame: at 1,3, 6 months post-index procedure]
  • 3.The rate of device related Major Adverse Events ( MAE ) and Serious Adverse Events（SAE） [Time frame: at 1,3, 6, 12months post-index procedure]
  • 4.The rate of unexpected secondary surgical or interventional procedures [Time frame: at 1,3, 6, 12months post-index procedure]
  • 5.Rate of Stent Thrombosis [Time frame: at 1,3, 6, 12months post-index procedure]
  • 6.Rate of all-cause mortality [Time frame: at 1,3, 6, 12months post-index procedure]
  • 7.The rate of displacement after stent implantation [Time frame: at 1,3, 6, 12months post-index procedure]
  • 8.The rate of Major Adverse Events ( MAE ) and Serious Adverse Events（SAE）during the study [Time frame: at 1,3, 6, 12months post-index procedure]

Eligibility criteria

Inclusion criteria

  • Patient must between 1 and 60 years old

Patients being clinically diagnosed with CoA or patients with post-operative anastomotic stenosis after CoA surgery，meanwhile meeting one of the following conditions:

A：Pressure gradient of Carctation in a calm state. B：The degree of aortic stenosis is not less than 50% (degree of Carctation Of the Arota = (diameter of adjacent normal segment of blood vessel - residual vessel lumen diameter of stenotic segment)

  • 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.
  • Reference vessel (diameter of the adjacent normal segment vessel ) diameter：4-16mm

Exclusion criteria

  • 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
  • Patients with contraindications on antiplatelet agents and anticoagulant therapy.
  • Patients with thrombosis at the vascular wall of target lesion and the distal or proximal location of the lesion.
  • Patients with known severe renal or hepatic insufficiency, which are unsuitable for index procedure
  • Target lesion to be treated where stent was implanted previously.
  • Patients with severe stenosis or excessive tortuosity in the targeted vessel, or anatomical abnormalities, which predict the device will have difficulty reaching the target lesion.
  • Other conditions that are unfavorable for stent delivery or balloon expansion.
  • Patient who have already participated in another clinical trial, and have not yet completed or withdrawn within 3 months before the screening period of this trial.
  • Patients who are not suitable for participating the trial as per investigator judgement.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Device feasibility

Study locations

China · 1 center
  • Fuwai Central China Cardiovascular Hospital — Zhengzhou

Identifiers

NCT: NCT07316855 · CoA-ICS-I · 251111314300

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗