NCT05659641

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

A Prospective, Multicenter, Open, Randomized Controlled, Non Inferiority Clinical Trial to Evaluate the Safety and Efficacy the Branch-based Intraoperative Stent System in the Treatment of Stanford A Aortic Dissection

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 259 (estimated)
• Sponsor: Permed Biomedical Engineering Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Aortic Dissection
• Aneurysm, Dissecting
• Aneurysm
• Vascular Diseases
• Cardiovascular Diseases

Interventions

Type	Name	Description
DEVICE	PerMed Stent Graft System In Surgical Operation	PerMed Branch Stent Graft
DEVICE	Endovastec CRONUS® Intraoperative stent system	CRONUS® Branch Stent Graft

Timeline

• Start date: 2023-01-18
• Primary completion: 2025-01-06
• Completion: 2029-02-28
• First posted: 2022-12-21
• Last updated: 2025-06-03

Locations

18 sites across 1 country: China