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A Multi-center, Open-label, Randomized, Control Study Compared with Imported Like Products to Evaluate the Efficacy and Safety of Domestic Abdominal Aortic Aneurysm Stent-Graft System

A Multi-center, Open-label, Randomized, Control Study Compared with Imported Like Products to Evaluate the Efficacy and Safety of Domestic Abdominal Aortic Aneurysm Stent-Graft System

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035393
Enrollment
Unknown
Registered
2020-08-09
Start date
2020-11-01
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

Infrarenal Abdominal Aortic Aneurysm

Interventions

Control:Medtronic Endurant stent graft
Experimental group:MicroPort Minos stent graft

Sponsors

Zhongshan Hospital Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Males or non-pregnant females aged >=18 years; 2. Definitive diagnosed with infrarenal abdominal aortic aneurysm 3. The length of the aneurysm neck >=15mm, and the angle between the neck and the aneurysm <=60 degree; 4. Suitable candidates for surgical treatment; 5. Available iliac and femoral artery access; 6. Suitable for endovascular treatment according to the researcher's judgment; 7. Patients who can understand the purpose of the trial, volunteer to participate and sign informed consent forms, and are willing to follow up.

Exclusion criteria

Exclusion criteria: 1. Landing zone with severe stenosis or calcification, which is difficult to adhere to; 2. Patients with ruptured aneurysm or acute aneurysm; 3. Patients with infectious aneurysm; 4. Diagnosed with suprarenal aneurysm and pararenal aneurysm; 5. Patients without at least one internal iliac artery; 6. History of myocardial infarction or unstable angina pectoris in the past 3 months; 7. History of TIA or cerebral infarction in the past 3 months; 8. Allergic to contrast media, Nitinol and other stent materials; 9. Patients with connective tissue diseases, such as Marfan syndrome; 10. Patients whose creatinine exceeds 2.5 times the upper limit of normal or who are on dialysis; 11. Patients with severe disease such as liver failure; 12. Life expectancy < 12 months.

Design outcomes

Primary

MeasureTime frame
Freedom from MAE at 30 days;12-month clinical success rate;

Secondary

MeasureTime frame
Second intervention;All cause death;Aneurysm related death;Serious adverse event;Device-related adverse events;

Countries

China

Contacts

Public ContactWeiguo Fu

Zhongshan Hospital Fudan University

fu.weiguo@zs-hospital.sh.cn+86 13801760929

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026