NCT05996354

Concave Supra-arch Branched Stent-Graft System for Treatment of Aortic Arch Diseases

A Study on the Concave Supra-arch Branched Stent-Graft System for Treatment of Aortic Arch Diseases

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: China National Center for Cardiovascular Diseases · Other Government
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

There are no endoluminal stent systems available on the Chinese market for the effective treatment of aortic arch lesions (involving aortic arch aneurysms, aortic coarctation, aortic pseudoaneurysms, aortic ulcers, and intermural hematomas), and therefore this study is intended to be a prospective, single-arm study.

Detailed description

The physician shall strictly follow the clinical study protocol and shall not deviate from or substantially change the protocol. However, in case of emergency such as immediate risk to the subjects, which needs to be eliminated immediately, it may be reported in written form afterwards. During the course of the study, documents such as amendments to the clinical study protocol and informed consent, requests for deviation, and resumption of the suspended clinical study shall be subject to the written approval of the Ethics Committee.

Conditions

• Aortic Dissection
• Aneurysm, Aortic Arch
• Aortic Pseudoaneurysm
• Aortic Ulcer, Penetrating
• Aortic Intramural Hematoma

Interventions

Type	Name	Description
DEVICE	Concave Supra-arch Branched stent-graft system	To evaluate the efficacy and safety of the Concave Supra-arch Branched stent-graft system for endovascular treatment of aortic arch diseases.

Timeline

• Start date: 2022-03-01
• Primary completion: 2023-10-01
• Completion: 2025-04-30
• First posted: 2023-08-18
• Last updated: 2023-10-11

Locations

3 sites across 1 country: China