The Branch-based Intraoperative Stent System in the Treatment of Stanford A Aortic Dissection（BROAD）

Permed Biomedical Engineering

Status: Active, not recruiting

Conditions: Aneurysm; Aneurysm, Dissecting; Cardiovascular Diseases; Vascular Diseases; Aortic Dissection

Treatments: Device: PerMed Stent Graft System In Surgical Operation; Device: Endovastec CRONUS® Intraoperative stent system

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05659641

IS-CT（CN）

Details and patient eligibility

About

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

Full 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.

Enrollment: 259 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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259 participants in 3 patient groups

Branched Surgical Stent Graft System,

Experimental group

Description:

Learning curve case group Experimental: Beijing PerMed Branched Surgical Stent Graft System,Permedos apex.

Treatment:

Device: PerMed Stent Graft System In Surgical Operation

Single Branch Structure Stent Graft System single group

Experimental group

Description:

Beijing PerMed single branch intraoperative stent system

Treatment:

Device: PerMed Stent Graft System In Surgical Operation

CRONUS® Stent Graft System In Surgical Operation

Other group

Description:

Control group：CRONUS® Stent Graft

Treatment:

Device: Endovastec CRONUS® Intraoperative stent system