A single-center, feasible clinical study to Evaluate the Treatment of Iron Bioresorbable Covered Scaffold System in patients with Coarctation of the Aorta Diseases
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 \[Defined on a per target lesion basis\]
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
10
A novel bioresorbable iron-based covered stent for coarctation of the aorta
Fuwai Central China Cardiovascular Hospital
Zhengzhou, Henan, China
RECRUITING1.Rate of no stent restenosis[Defined on a per target lesion basis]
Definition of stent restenosis: If the pressure difference within the stent on transthoracic echocardiography is 50% higher than the result of transthoracic echocardiography at 0-1 days post-procedure, will be considered as suspected restenosis.
Time frame: at 12 months post-procedure
2.Acute Procedure Success
Definition of Acute Procedure Success:Meeting any one of the following standards after the stent is delivered to the target lesion site and expanded during the procedure A.The pressure difference between the proximal and distal ends of the stenosis decreased by≥50% ,detected by right heart catheterization after the stent being placed. B.The inner diameter of the original stenotic segment of the blood vessel increases by ≥50% after the stent is placed,detected by pulmonary artery angiography after the stent being placed.
Time frame: after the stent is delivered to the target lesion site and expanded during the procedure
1.Acute Technical Success
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
defined on a per target lesion basis,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)
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
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unexpected secondary surgical or interventional procedures (excluding the expected secondary intervention procedures)
Time frame: at 1,3, 6, 12months post-index procedure
5.Rate of Stent Thrombosis
Stent Thrombosis
Time frame: at 1,3, 6, 12months post-index procedure
6.Rate of all-cause mortality
all-cause mortality
Time frame: at 1,3, 6, 12months post-index procedure
7.The rate of displacement after stent implantation
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
Major Adverse Events ( MAE ) and Serious Adverse Events(SAE)during the study
Time frame: at 1,3, 6, 12months post-index procedure