Aneurysm, Aneurysm, Dissecting, Aortic Dissection, Cardiovascular Diseases, Vascular Diseases
Conditions
Keywords
Stanford A aortic dissection
Brief summary
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
Detailed description
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.
Interventions
DEVICEPerMed Stent Graft System In Surgical Operation
PerMed Branch Stent Graft
DEVICEEndovastec CRONUS® Intraoperative stent system
CRONUS® Branch Stent Graft
Sponsors
Shanghai Zhongshan Hospital
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Fujian Medical University Union Hospital
West China Hospital
Changhai Hospital
Yunnan Cardiovascular hospital
First Affiliated Hospital Xi'an Jiaotong University
Anhui Provincial Hospital
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Southwest Hospital, China
First Affiliated Hospital of Xinjiang Medical University
Linyi People's Hospital
The First Hospital of Jilin University
Second Affiliated Hospital of Nanchang University
First Affiliated Hospital of Harbin Medical University
The First Hospital of Hebei Medical University
The University of Hong Kong-Shenzhen Hospital
Qilu Hospital of Shandong University
Xiamen Cardiovascular Hospital, Xiamen University
Permed Biomedical Engineering Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Learning Curve+Parallel+Single Group
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 and ≤ 75 years, male or female; 2. Stanford type A aortic dissection subjects with involvement of the descending arch aorta； 3. Subjects treated with stent pictorial procedures as judged appropriate by the investigator； 4. Subjects or their legal surrogates were able to understand the purpose of the study, had adequate compliance to the clinical study protocol, and voluntarily signed the informed consent form.
Exclusion criteria
1. Subjects with aortic dissections confined to the ascending and / or arch 2. Subjects with a left common carotid artery branch vessel diameter \< 5 mm or \> 16 mm (not applicable to subjects enrolled with a single branch structure) 3. Subjects with a left subclavian artery branch vessel diameter \< 7 mm or \> 16 mm 4. Subjects with aortic dissection with severe malperfusion syndrome preoperatively (e.g., subjects presenting with coma, paraplegia, need for dialysis, gastrointestinal necrosis or limb necrosis due to ischemia, etc.) 5. Subjects with vertebral artery variants 6. Subjects with infectious aortic dissections 7. Subjects with acute systemic infection, severe infection and associated sepsis, shock or multiple organ failure 8. Subjects unable to tolerate anaesthesia and cardiopulmonary bypass 9. Subjects who had undergone open surgical procedures of the cardiocerebral vasculature within 90 days prior to surgery 10. Subjects with history of active bleeding, coagulopathy or refusal of blood transfusion 11. Subjects known to be allergic to materials such as contrast agents, nitinol alloys, coated artificial blood vessels 12. Subjects with a life expectancy of less than 12 months (other than disease due to aortic dissection) 13. Subjects being enrolled in other clinical trials 14. Pregnant and lactating women, and subjects with a recent pregnancy preparation 15. Subjects with poor compliance other conditions that the investigator considers inappropriate for participation in the clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All cause mortality | after procedure 1 year | Percentage of subjects who died from any cause within 12 months ±30 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operation success rate | Immediately after procedure | It refers to the proportion of subjects who have completed the expected surgical treatment |
| 30 day all-cause mortality after procedure | 30 day | It refers to the proportion of dead subjects within 30 days (including 30 days) after operation |
| false-lumen thrombosis rates | 6 month, 1 year | 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. |
| Branch patency | 1 year | 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. |
| Secondary intervention rate of target lesions | 1 year | The proportion of participants with unexpected re intervention due to the trial or control device. |
| Device implantation success rate | Immediately after implantation | 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. |
| Incidence of spinal cord ischemia | 1 year | 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 |
| Incidence of acute kidney injury | 1 year | 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. |
| Mortality associated with aortic dissection | 30 day | 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 |
| Incidence of device-related adverse events | 6month，1 year，5 year | 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. |
| stroke rate | 1 year | 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 |
Countries
China
Outcome results
None listed