The purpose of the study was to evaluate the safety and efficacy of a branched type intraoperative stent system for the treatment of Stanford type A aortic dissection
Types The clinical trial design was prospective, muticenter, open, randomized controlled design with an additional single group design. Plan Before the randomized controlled trial, each center will enroll one subject as a learning curve case(only use PerMed double branched structures). 212 participants were planned to be enrolled from no less than 10 qualified clinical research institutions and randomly assigned 1:1 to the intraoperative stent systems of Endovastec and the branched type intraoperative stent systems of PerMed double branched structures. An additional 30 subjects were enrolled using a branched type intraoperative stent system with a single branch structure from PerMed, Beijing. All enrolled participants were followed up clinically intraoperatively, before discharge or 30 days ± 7 days after procedure, 6 months ± 30 days after procedure, 12 months ± 30 days after procedure, and 2-5 years after procedure.Non inferiority of the trial product to the control product was assessed with the primary end point of all-cause mortality at 12 months after procedure. The statistical analysis and summary report will be conducted based on the 12-month follow-up data of all subjects, and the application for medical device registration will be carried out. The long-term efficacy and safety evaluation of the product will be carried out after long-term follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
259
PerMed Branch Stent Graft
CRONUS® Branch Stent Graft
Anhui Provincial Hospital
Hefei, Anhui, China
First Hospital Affiliated to the Army Medical University
Chongqing, Chongqing Municipality, China
All cause mortality
Percentage of subjects who died from any cause within 12 months ±30 days
Time frame: after procedure 1 year
Device implantation success rate
Refers to the proportion of successful device implantation. That is, the test product or control product was successfully introduced into the true lumen of the vessel and successfully released, the delivery system was successfully withdrawn, and the anastomosis was completed with the artificial vessel.
Time frame: Immediately after implantation
Operation success rate
It refers to the proportion of subjects who have completed the expected surgical treatment
Time frame: Immediately after procedure
30 day all-cause mortality after procedure
It refers to the proportion of dead subjects within 30 days (including 30 days) after operation
Time frame: 30 day
false-lumen thrombosis rates
Complete thrombosis refers to the rate of complete thrombosis of the entire aortic false lumen on arterial phase and delayed phase imaging. Partial thrombogenicity refers to the rate of presence of thrombus in the false lumen but residual flow in the arterial and delayed phases. Details are described in the 2022 ACC guidelines for the diagnosis and management of AHA aortic disease.
Time frame: 6 month, 1 year
Branch patency
The proportion of subjects with stenosis degree of left subclavian artery and/or left common carotid artery less than 50% within 12 months after procedure.
Time frame: 1 year
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Fujian Medical University Union Hospital
Fuzhou, Fujian, China
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Wuhan Union Hospital, China
Wuhan, Hubei, China
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The First Hospital of Jilin University
Changchun, Jilin, China
First Affiliated Hospital Xi'an Jiaotong University
Xi'an, Shaanxi, China
...and 8 more locations
Secondary intervention rate of target lesions
The proportion of participants with unexpected re intervention due to the trial or control device.
Time frame: 1 year
stroke rate
It refers to a cerebrovascular event caused by the implantation of the test product or control product, which shows partial or complete loss of movement or sensation, and lasts for more than 24 hours
Time frame: 1 year
Incidence of spinal cord ischemia
It refers to the ratio of subjects with spinal cord functional defects caused by ischemia after the implantation of the experimental or control device. Except those caused by tumor, trauma, tuberculosis and other factors with clear causes
Time frame: 1 year
Incidence of acute kidney injury
Renal hypofunction refers to the increase of serum creatinine (SCR) ≥ 50% compared with the basic value (SCR value in screening period) and (or) urine volume\<0.5 ml/(kg · h)\>6 h. Except for acute renal injury caused by poisoning and other clear causes.
Time frame: 1 year
Mortality associated with aortic dissection
It refers to the proportion of subjects who died of aortic dissection within 30 days (inclusive) after operation or within 30 days (inclusive) after the secondary intervention of target lesion
Time frame: 30 day
Incidence of device-related adverse events
It refers to the ratio of device related adverse events occurring after the implantation of the test product in the follow-up period to the total adverse events.
Time frame: 6month,1 year,5 year