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Prospective, Multi-Center and Single-Arm Evaluation of the Safety and Efficacy of the In-Situ Fenestration System for the Preservation of the Supra-Arch Artery in the TEVAR for Aortic Arch Pathologies

Prospective, Multi-Center and Single-Arm Evaluation of the Safety and Efficacy of the In-Situ Fenestration System for the Preservation of the Supra-Arch Artery in the TEVAR for Aortic Arch Pathologies

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900026696
Enrollment
Unknown
Registered
2019-10-19
Start date
2019-11-01
Completion date
Unknown
Last updated
2020-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic arch pathologies

Interventions

trial group:In-situ fenestration in TEVAR

Sponsors

Zhongshan Hospital Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-80 years; 2. Patients who understand the objectives of this study, and are willing to sign informed consent files by themselves or their legal representatives; 3. Patients with good compliance to accomplish follow-up; 4. Life expectancy > 1 year; 5. Definitive diagnosis of aortic arch dilatation disease involving supra-arch vessels; 6. Suitable candidates for surgery with available access arteries.

Exclusion criteria

Exclusion criteria: 1. Patients who are not suitable for vascular intervention therapy; 2. Severe multi-organ failure or malignant tumor; 3. Allergic to intravascular contrast media; 4. History of myocardial infarction, TIA or stroke in the past three months;

Design outcomes

Primary

MeasureTime frame
Freedom from MAE at 30 days;

Secondary

MeasureTime frame
Success rate of technology;

Countries

China

Contacts

Public ContactYi Si

Zhongshan Hospital Fudan University

sysiy@yahoo.com+86 15921314969

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 16, 2026