Concave Supra-arch Branched Stent-Graft System for Treatment of Aortic Arch Diseases
NCT05996354 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2023-10-11
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.
Conditions
- Aortic Dissection
- Aneurysm, Aortic Arch
- Aortic Pseudoaneurysm
- Aortic Ulcer, Penetrating
- Aortic Intramural Hematoma
Interventions
- 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.
Sponsors & Collaborators
-
China National Center for Cardiovascular Diseases
lead OTHER_GOV
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-03-01
- Primary Completion
- 2023-10-01
- Completion
- 2025-04-30
Countries
- China
Study Locations
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