Study on the Safety and Efficacy of the Aortic Arch Single Branch Covered Stent System for Aortic Dissection Involving the Aortic Arch

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The objective of the study is to evaluate the Safety and Efficacy of Aortic Arch Single Branch Covered Stent System for Aortic Dissection Involving the Aortic Arch

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Age between 18 and 80 years, gender unrestricted.

• Patients are diagnosed with Stanford Type B aortic dissection and need revascularization of the left subclavian artery.

• Anatomical criteria:

‣ The diameter range of the proximal aortic landing zone is 20-42 mm.

⁃ The length of the proximal aortic landing zone (the distance from the posterior edge of the left common carotid artery orifice to the first intimal tear) is ≥15 mm.

⁃ The distance between the left common carotid artery and the left subclavian artery is ≥5 mm.

⁃ The length of the left subclavian artery landing zone is ≥25 mm, and the diameter range of the landing zone is 5-15 mm.

⁃ Suitable access to the femoral artery, iliac artery, and upper limb artery.

• Patients understand the purpose of the study, volunteer to participate, and are willing to complete follow - up visits as required by the protocol.

Locations
Other Locations
China
Second Xiangya Hospital of Central South University
RECRUITING
Changsha
Contact Information
Primary
chang shu, Professor
changshu01@yahoo.com
13607444222
Time Frame
Start Date: 2025-04-30
Estimated Completion Date: 2031-06-30
Participants
Target number of participants: 135
Treatments
Experimental: Aortic Arch Single Branch Covered Stent System
Aortic Arch Single Branch Covered Stent System for Aortic Dissection Involving the Aortic Arch
Related Therapeutic Areas
Sponsors
Leads: Lifetech Scientific (Shenzhen) Co., Ltd.

This content was sourced from clinicaltrials.gov